<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972658</url>
  </required_header>
  <id_info>
    <org_study_id>16557</org_study_id>
    <secondary_id>I8D-MC-AZFD</secondary_id>
    <secondary_id>2016-003440-36</secondary_id>
    <nct_id>NCT02972658</nct_id>
  </id_info>
  <brief_title>A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia</brief_title>
  <official_title>A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The&#xD;
      purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in&#xD;
      participants with early Alzheimer's disease dementia at the time of entry into study&#xD;
      I8D-MC-AZES.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start&#xD;
      study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants&#xD;
      originally randomized to receive placebo in the double-blind feeder study AZES and switched&#xD;
      to LY3314814 at the start of study AZFD did not &quot;catch up&quot; on the Alzheimer's Disease&#xD;
      Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants&#xD;
      originally randomized to receive LY3314814 in the double-blind feeder study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As the feeder study (AZES) was stopped for futility after an independent assessment, this trial&#xD;
    was also stopped.&#xD;
  </why_stopped>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">October 2, 2018</completion_date>
  <primary_completion_date type="Actual">October 2, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</measure>
    <time_frame>AZES Baseline through AZFD Week 26</time_frame>
    <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</measure>
    <time_frame>AZES Baseline through AZFD Week 26</time_frame>
    <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</measure>
    <time_frame>AZES Baseline through AZFD Week 26</time_frame>
    <description>FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</measure>
    <time_frame>AZES Baseline through AZFD Week 26</time_frame>
    <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on the Mini-Mental Status Examination (MMSE)</measure>
    <time_frame>AZES Baseline through AZFD Week 26</time_frame>
    <description>The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Analysis on the ADAS-Cog13</measure>
    <time_frame>AZES Baseline through AZFD Week 52</time_frame>
    <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">421</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZES Placebo/AZFD Lanabecestat 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZES Placebo/AZFD Lanabecestat 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanabecestat</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg</arm_group_label>
    <arm_group_label>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</arm_group_label>
    <arm_group_label>AZES Placebo/AZFD Lanabecestat 20 mg</arm_group_label>
    <arm_group_label>AZES Placebo/AZFD Lanabecestat 50 mg</arm_group_label>
    <other_name>LY3314814</other_name>
    <other_name>AZD3293</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility&#xD;
             criteria for delayed-start I8D-MC-AZFD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who participate in AMARANTH (NCT02245737) who develop new conditions&#xD;
             precluding them from enrolling into I8D-MC-AZFD.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Alzheimer's Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Territory Neurology &amp; Research Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Network Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mile High Research Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Neurodegenerative Disorders</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIC, Inc.</name>
      <address>
        <city>Palmetto Bay</city>
        <state>Florida</state>
        <zip>33157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Neuroscience Associates</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roskamp Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premiere Research Institute at Palm Beach Neurology</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Multiple Sclerosis Center of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30327</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research Center</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Center for Memory</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Enhancement Center of America, Inc.</name>
      <address>
        <city>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cognitive and Research Center of NJ</name>
      <address>
        <city>Springfield</city>
        <state>New Jersey</state>
        <zip>07081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Memory Research Institute of New Jersey</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials, LLC</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester School of Medicine</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Primary Care</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Mood &amp; Memory Research Institute</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quillen College of Medicine, East TN State University</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Memory Clinic</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Neurology</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Clinical Research Unit</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmont Private Hospital</name>
      <address>
        <city>Glen Iris</city>
        <state>Victoria</state>
        <zip>3146</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Florey Institute of Neuroscience and Mental Health</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian Alzheimer's Research Foundation</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro Trials Victoria Pty Ltd</name>
      <address>
        <city>Noble Park</city>
        <zip>3174</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Universitaire Brugmann Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitaire Erasme Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okanagan Clinical Trials</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>True North Clinical Research Halifax, LLC</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3S1M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elizabeth Bruyere Health Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>KIN 5C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawartha Regional Memory Clinic</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9H2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Memory Program</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Memoire de l'Outaouais</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8T 8J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroSearch Developements</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de L'Enfant Jesus</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q&amp;T Research Sherbrooke Inc</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1J 2G2</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Centre Hospitalier Universitaire La Timone</name>
      <address>
        <city>Marseille</city>
        <state>Cedex 05</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille- Hôpital Roger Salengro</name>
      <address>
        <city>Lille</city>
        <state>Cedex</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse Hopital Purpan</name>
      <address>
        <city>Toulouse</city>
        <state>Cedex</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Neuro Pierre Wertheimer</name>
      <address>
        <city>Bron Cedex</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bocage CMRR</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Broca</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Fernand Widal</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Nantes Hopital Laennec</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Clinique du Gérontopôle Cité de la Santé</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital des Charpennes</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Württemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Studien und Gedächtniszentrum München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar der TU München</name>
      <address>
        <city>München</city>
        <state>Bayern</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Neurologie und Psychiatrie</name>
      <address>
        <city>Westerstede</city>
        <state>Niedersachsen</state>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DataMed Klinische Studien GmbH</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Praxis Siegen</name>
      <address>
        <city>Siegen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>57076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharm Studienzentrum Chemnitz</name>
      <address>
        <city>Mittweida</city>
        <state>Sachsen</state>
        <zip>09648</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SE Neurologiai Klinika</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute for Longevity Sciences NCGG</name>
      <address>
        <city>Obu</city>
        <state>Aichi</state>
        <zip>474-0038</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Chiba-East-Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Chiba</state>
        <zip>260-8712</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tsukuba University Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon Kokan Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>210-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katayama Medical Clinic</name>
      <address>
        <city>Kurashiki</city>
        <state>Okayama</state>
        <zip>701-0192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiroma Clinic</name>
      <address>
        <city>Urasoe</city>
        <state>Okinawa</state>
        <zip>901-2102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakaguchi Clinic</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>593-8301</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Sanatorium Toneyama Hospital</name>
      <address>
        <city>Toyonaka</city>
        <state>Osaka</state>
        <zip>560-8552</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Clinic Ochanomizu</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-0034</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Bunkyo-Ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Sanatorium Hokuriku Hospital</name>
      <address>
        <city>Nanto</city>
        <state>Toyama</state>
        <zip>939-1893</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utano Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>616-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>637086</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Medical Center</name>
      <address>
        <city>Seogu</city>
        <state>Busan</state>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanyang University Guri Hospital</name>
      <address>
        <city>Guri-si</city>
        <state>Gyeonggido</state>
        <zip>11923</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Junggu</city>
        <state>Incheon</state>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podlaskie Centrum Psychogeriatrii</name>
      <address>
        <city>Białystok</city>
        <state>Podlaskie</state>
        <zip>15-732</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Dom Sue Ryder - Pallmed Sp. z o.o.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Wielospecjalistyczna Poradnia Lekarska</name>
      <address>
        <city>Katowice</city>
        <zip>40-123</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Zdrowia Psychicznego Biomed - Jan Latala</name>
      <address>
        <city>Kielce</city>
        <zip>25-411</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowska Akademia Neurologii</name>
      <address>
        <city>Krakow</city>
        <zip>31-505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medycyna Milorzab</name>
      <address>
        <city>Lodz</city>
        <zip>93-118</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Medycyny Wsi</name>
      <address>
        <city>Lublin</city>
        <zip>20-950</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Neuroprotect</name>
      <address>
        <city>Warszawa</city>
        <zip>01-697</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Cruz Behavioral PSC</name>
      <address>
        <city>Bayamón</city>
        <zip>00961-6911</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Med Life SA</name>
      <address>
        <city>Bucuresti</city>
        <zip>010719</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Centrul Medical Sana SRL</name>
      <address>
        <city>Bucuresti</city>
        <zip>011025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen Del Puerto</name>
      <address>
        <city>Plasencia</city>
        <state>Caceres</state>
        <zip>10600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario De Getafe</name>
      <address>
        <city>Madrid</city>
        <state>Getafe</state>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITA Alzheimer</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Atencion Especializada (CAE) OROITU</name>
      <address>
        <city>Getxo</city>
        <state>Vizcaya</state>
        <zip>48993</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion ACE-Institut Catala de Neurociences Aplicades</name>
      <address>
        <city>Barcelona</city>
        <zip>08014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic I Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma De Mallorca</city>
        <zip>07010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr Pesset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Re-Cognition Health Ltd</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>W1G 9JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research-Manchester</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M13 9NQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Blackpool</city>
        <state>Lancashire</state>
        <zip>FY2 0JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>West London Mental Health NHS Trust</name>
      <address>
        <city>Isleworth</city>
        <state>London</state>
        <zip>TW7 6FY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Cannock</city>
        <state>Staffordshire</state>
        <zip>WS11 0BN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Re-Cognition Health Ltd</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glasgow Memory Clinic</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAC Clinical Research</name>
      <address>
        <city>Leeds</city>
        <zip>LS10 1DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
  </removed_countries>
  <link>
    <url>https://www.lillytrialguide.com/en-US/studies/alzheimer-s/AZFD#?postal=</url>
    <description>Click here for more information about this study: A Study of LY3314814 in Early Alzheimer's Disease Dementia</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=16557&amp;amp;attachmentIdentifier=a046bc93-718a-4179-8f30-4b65da56a317&amp;amp;fileName=CSP_NCT02972658.pdf&amp;amp;versionIdentifier=</url>
    <description>CSP</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=16557&amp;amp;attachmentIdentifier=a6ee5d0a-4796-4efd-b082-e84fbcbac489&amp;amp;fileName=SAP_NCT02972658.pdf&amp;amp;versionIdentifier=</url>
    <description>SAP</description>
  </link>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>June 11, 2019</results_first_submitted>
  <results_first_submitted_qc>June 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 5, 2019</results_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Dementia</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Neurodegenerative Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Delirium, Dementia, Amnestic, Cognitive Disorders</keyword>
  <keyword>Tauopathies</keyword>
  <keyword>Memory</keyword>
  <keyword>Amyloid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02972658/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02972658/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who completed feeder study [AZES (NCT02245737)] were enrolled in this study.</recruitment_details>
      <pre_assignment_details>Participants who were randomized in Study AZES to either 20 milligrams (mg) or 50 mg of lanabecestat continued on the treatment allocation from the feeder study. Participants randomized to placebo in Study AZES were randomized in a blinded fashion, 1:1 ratio, to either lanabecestat 20 mg or 50 mg daily (QD), administered orally.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
        </group>
        <group group_id="P2">
          <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
        </group>
        <group group_id="P3">
          <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
        </group>
        <group group_id="P4">
          <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="139"/>
                <participants group_id="P3" count="74"/>
                <participants group_id="P4" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1">1 participant was incorrectly marked as &quot;Completed&quot; rather than study terminated by Sponsor.</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="138"/>
                <participants group_id="P3" count="75"/>
                <participants group_id="P4" count="131"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other-determined by Investigator</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal due to Caregiver Circumstance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="127"/>
                <participants group_id="P3" count="72"/>
                <participants group_id="P4" count="119"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
        </group>
        <group group_id="B2">
          <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.</description>
        </group>
        <group group_id="B3">
          <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
        </group>
        <group group_id="B4">
          <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="76"/>
            <count group_id="B2" value="139"/>
            <count group_id="B3" value="75"/>
            <count group_id="B4" value="131"/>
            <count group_id="B5" value="421"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Details are from AZES baseline.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.7" spread="6.6"/>
                    <measurement group_id="B2" value="69.8" spread="7.8"/>
                    <measurement group_id="B3" value="71.1" spread="6.6"/>
                    <measurement group_id="B4" value="70.1" spread="6.7"/>
                    <measurement group_id="B5" value="70.3" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="75"/>
                    <measurement group_id="B5" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="56"/>
                    <measurement group_id="B5" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="114"/>
                    <measurement group_id="B5" value="345"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="325"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Puerto Rico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ADAS-Cog13 (13-item Alzheimer's Disease Assessment Scale)</title>
          <description>ADAS-Cog13, a 13-item rating scale, measured the severity of cognitive dysfunction in persons with Alzheimer's disease (AD). Scores ranged from 0 to 85, with a higher score indicating worse cognitive functioning. Details are from AZES baseline.</description>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.9" spread="8.3"/>
                    <measurement group_id="B2" value="29.6" spread="7.8"/>
                    <measurement group_id="B3" value="27.0" spread="7.5"/>
                    <measurement group_id="B4" value="27.1" spread="7.5"/>
                    <measurement group_id="B5" value="27.9" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</title>
        <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 26</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure. Feeder study AZES was stopped for futility, the original Delayed Start analysis was replaced with MMRM analysis and no comparisons between treatment groups were made.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)</title>
          <description>ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure. Feeder study AZES was stopped for futility, the original Delayed Start analysis was replaced with MMRM analysis and no comparisons between treatment groups were made.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.61" spread="1.60"/>
                    <measurement group_id="O2" value="9.25" spread="1.21"/>
                    <measurement group_id="O3" value="8.41" spread="1.65"/>
                    <measurement group_id="O4" value="10.41" spread="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</title>
        <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 26</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)</title>
          <description>The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.19" spread="1.47"/>
                    <measurement group_id="O2" value="-8.45" spread="1.10"/>
                    <measurement group_id="O3" value="-7.37" spread="1.51"/>
                    <measurement group_id="O4" value="-7.48" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</title>
        <description>FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 26</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Functional Activities Questionnaire (FAQ) Score</title>
          <description>FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="137"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.28" spread="0.98"/>
                    <measurement group_id="O2" value="7.09" spread="0.76"/>
                    <measurement group_id="O3" value="6.73" spread="1.01"/>
                    <measurement group_id="O4" value="6.91" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</title>
        <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 26</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score</title>
          <description>The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="138"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="123"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.85" spread="2.58"/>
                    <measurement group_id="O2" value="-17.57" spread="1.97"/>
                    <measurement group_id="O3" value="-15.37" spread="2.76"/>
                    <measurement group_id="O4" value="-18.37" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on the Mini-Mental Status Examination (MMSE)</title>
        <description>The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 26</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on the Mini-Mental Status Examination (MMSE)</title>
          <description>The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.84" spread="0.71"/>
                    <measurement group_id="O2" value="-5.73" spread="0.54"/>
                    <measurement group_id="O3" value="-4.72" spread="0.72"/>
                    <measurement group_id="O4" value="-5.25" spread="0.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Analysis on the ADAS-Cog13</title>
        <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
        <time_frame>AZES Baseline through AZFD Week 52</time_frame>
        <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.</population>
        <group_list>
          <group group_id="O1">
            <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O2">
            <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
            <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
          </group>
          <group group_id="O3">
            <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
          <group group_id="O4">
            <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
            <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Analysis on the ADAS-Cog13</title>
          <description>ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.</description>
          <population>All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="139"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.64" spread="3.45"/>
                    <measurement group_id="O2" value="12.40" spread="2.25"/>
                    <measurement group_id="O3" value="16.79" spread="2.47"/>
                    <measurement group_id="O4" value="15.05" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up To 156 Weeks</time_frame>
      <desc>All AZFD participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>AZES Placebo/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
        </group>
        <group group_id="E2">
          <title>AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg</title>
          <description>Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.</description>
        </group>
        <group group_id="E3">
          <title>AZES Placebo/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
        </group>
        <group group_id="E4">
          <title>AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg</title>
          <description>Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Oesophageal motility disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Radiation proctitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram repolarisation abnormality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Laryngeal squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Neuropsychiatric symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="139"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="76"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="139"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="74"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="139"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="76"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="139"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="76"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="139"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor shall review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Investigator shall delay publication of their results of the study until the results of the multi-center study are published or presented, provided the multi-center results are published within 24 months of the termination.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was stopped after an independent assessment concluded that the feeder study AZES was futile. Because of this, the originally planned delayed-start analysis for this study was not performed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>AstraZeneca Information Center</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972658
org study id: 16557
secondary id: I8D-MC-AZFD
secondary id: 2016-003440-36
nct id: NCT02972658
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The
      purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in
      participants with early Alzheimer's disease dementia at the time of entry into study
      I8D-MC-AZES.
Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start
      study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants
      originally randomized to receive placebo in the double-blind feeder study AZES and switched
      to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease
      Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants
      originally randomized to receive LY3314814 in the double-blind feeder study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
time frame: AZES Baseline through AZFD Week 26
description: ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
measure: Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)
time frame: AZES Baseline through AZFD Week 26
description: The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
measure: Change From Baseline on the Functional Activities Questionnaire (FAQ) Score
time frame: AZES Baseline through AZFD Week 26
description: FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
measure: Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score
time frame: AZES Baseline through AZFD Week 26
description: The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
measure: Change From Baseline on the Mini-Mental Status Examination (MMSE)
time frame: AZES Baseline through AZFD Week 26
description: The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
measure: Change From Baseline Analysis on the ADAS-Cog13
time frame: AZES Baseline through AZFD Week 52
description: ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.
arm group label: AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg
arm group type: Experimental
description: Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
arm group label: AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
arm group type: Experimental
description: Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
arm group label: AZES Placebo/AZFD Lanabecestat 20 mg
arm group type: Experimental
description: Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
arm group label: AZES Placebo/AZFD Lanabecestat 50 mg
arm group type: Experimental
description: Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
intervention type: Drug
intervention name: Lanabecestat
description: Administered orally
arm group label: AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg
arm group label: AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
arm group label: AZES Placebo/AZFD Lanabecestat 20 mg
arm group label: AZES Placebo/AZFD Lanabecestat 50 mg
other name: LY3314814
other name: AZD3293
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Hungary
country: Japan
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Romania
country: Spain
country: United Kingdom
country: United States
country: Italy
url: https://www.lillytrialguide.com/en-US/studies/alzheimer-s/AZFD#?postal=
description: Click here for more information about this study: A Study of LY3314814 in Early Alzheimer's Disease Dementia
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=16557&amp;attachmentIdentifier=a046bc93-718a-4179-8f30-4b65da56a317&amp;fileName=CSP_NCT02972658.pdf&amp;versionIdentifier=
description: CSP
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=16557&amp;attachmentIdentifier=a6ee5d0a-4796-4efd-b082-e84fbcbac489&amp;fileName=SAP_NCT02972658.pdf&amp;versionIdentifier=
description: SAP
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://www.clinicalstudydatarequest.com/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was stopped after an independent assessment concluded that the feeder study AZES was futile. Because of this, the originally planned delayed-start analysis for this study was not performed.
point of contact: 