<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/NCT03823404</url>
  </required_header>
  <id_info>
    <org_study_id>COR388-010</org_study_id>
    <nct_id>NCT03823404</nct_id>
  </id_info>
  <brief_title>GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease</brief_title>
  <official_title>GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cortexyme Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cortexyme Inc.</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 is a randomized, double-blind, placebo-controlled study that assessed the efficacy,&#xD;
      safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of&#xD;
      mild to moderate Alzheimer's disease (AD) dementia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, double-blind, placebo-controlled study that assessed the efficacy,&#xD;
      safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable&#xD;
      Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's&#xD;
      Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging&#xD;
      abnormalities that could explain the symptoms of dementia. All subjects were encouraged to&#xD;
      have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical&#xD;
      conditions that could increase the risk of the procedure in the opinion of the Investigator.&#xD;
      Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of&#xD;
      AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of&#xD;
      Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical&#xD;
      evidence of periodontitis at baseline, 24 and 48 weeks.&#xD;
&#xD;
      The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up&#xD;
      to 48 weeks, and a safety follow-up phase of 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">January 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 2022</primary_completion_date>
  <phase>Phase 2/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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.&#xD;
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Dementia Rating-Sum of Boxes (CDR-SB)</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.&#xD;
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examination (MMSE)</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory (NPI)</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.&#xD;
Total score ranges from 12 to 144; higher scores indicate greater disease severity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anti-P. Gingivalis IgG in Serum</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Anti-P. gingivalis immunoglobulin G (IgG) in serum&#xD;
Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)&#xD;
Lower levels represent a pharmacodynamic effect of the drug on its target</description>
  </other_outcome>
  <other_outcome>
    <measure>Magnetic Resonance Imaging</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Change in magnetic resonance imaging - bilateral whole brain volume&#xD;
Larger volume may represent effect of the drug on its target</description>
  </other_outcome>
  <other_outcome>
    <measure>Periodontal (or Gum) Pocket Depth</measure>
    <time_frame>Baseline to Week 48</time_frame>
    <description>Periodontal (or gum) pocket depth - pocket depth for only sites with depth &gt;= 4mm.&#xD;
The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.&#xD;
Larger measure means worse outcome</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">643</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>COR388 80 mg twice daily (BID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COR388 40 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo BID</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COR388 capsule</intervention_name>
    <description>BID (twice daily)</description>
    <arm_group_label>COR388 40 mg BID</arm_group_label>
    <arm_group_label>COR388 80 mg twice daily (BID)</arm_group_label>
    <other_name>atuzaginstat</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <description>BID</description>
    <arm_group_label>Placebo BID</arm_group_label>
    <other_name>atuzaginstat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Subject has probable AD dementia according to the NIA-AA criteria.&#xD;
&#xD;
          -  Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both&#xD;
             screening and Visit 2 and a ≤3-point difference between these visits.&#xD;
&#xD;
          -  Subject has brain MRI scan consistent with the diagnosis of AD performed during the&#xD;
             screening period. Computed Tomography scan can be used only if the subject has an&#xD;
             absolute contraindication for MRI.&#xD;
&#xD;
          -  Subject has a Modified Hachinski score ≤4 at screening.&#xD;
&#xD;
          -  Subjects with background symptomatic therapy with acetylcholine esterase inhibitors,&#xD;
             and/or memantine, are allowed as long as the dose has been stable for 90 days prior to&#xD;
             screening and no changes are planned during the study.&#xD;
&#xD;
          -  Subject has a primary caregiver willing to accept responsibility for supervising the&#xD;
             treatment (e.g., administering study drug) and assessing the condition of the subject&#xD;
             throughout the study in accordance with all protocol requirements.&#xD;
&#xD;
          -  Subject has body mass index &lt;38 kg/m2 at Screening&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Subject has imaging consistent with a dementia diagnosis other than AD.&#xD;
&#xD;
          -  Subject has had an increase or restoration of cognition based on medical history.&#xD;
&#xD;
          -  Subject with history or current evidence of major psychiatric illness such as&#xD;
             schizophrenia, bipolar disorder, or major depressive disorder that may interfere with&#xD;
             the patient's ability to perform the study and all assessments. Note: Mild depression&#xD;
             or depressive mood arising in the context of AD are not criteria for exclusion. The&#xD;
             use of anti-depressants or the use of anti epileptic medication for non&#xD;
             seizure-related treatment is allowed if the dose has remained stable for at least 60&#xD;
             days prior to enrollment.&#xD;
&#xD;
          -  Subject has any of the following laboratory findings at screening:&#xD;
&#xD;
               1. Alanine aminotransferase &gt;3 x upper limit of normal (ULN), aspartate&#xD;
                  aminotransferase &gt;3 x ULN, or history of clinically significant liver disease in&#xD;
                  the Investigator's judgment.&#xD;
&#xD;
               2. Hemoglobin ≤10 g/dl.&#xD;
&#xD;
               3. Creatinine clearance (CL) of &lt;45 ml/min.&#xD;
&#xD;
               4. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) &gt;8.&#xD;
&#xD;
               5. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B&#xD;
                  surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male and female.</gender_description>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Smith, MD</last_name>
    <role>Study Director</role>
    <affiliation>Quince Therapeutics Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xenoscience, Inc.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>Banner Sun Health</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ATP Clinical Research, Inc.</name>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <zip>92626</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Standford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITRIALS</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CITRIALS</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syrentis Clinical Research</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research LLC</name>
      <address>
        <city>Simi Valley</city>
        <state>California</state>
        <zip>93065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JEM Research Institute</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</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>Neuropsychiatric Research Center of Southwest Florida</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Clinical</name>
      <address>
        <city>Hallandale Beach</city>
        <state>Florida</state>
        <zip>33009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indago Research and Health Center, Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alzheimer's Research and Treatment Center</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qtrials, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Future Care Solutions, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Dade Medical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sensible Healthcare LLC</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anchor Neuroscience</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Neuroscience Associates, Inc.</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Matters Research at the Kane Center</name>
      <address>
        <city>Stuart</city>
        <state>Florida</state>
        <zip>34997</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stedman Clinical Trials</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columus Memory Center</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroStudies.net, LLC</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Trials</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Neurosciences Research</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi Research</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Activmed Practices and Research</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 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>Anil Nair MD, Alzheimer's Disease Center</name>
      <address>
        <city>Quincy</city>
        <state>Massachusetts</state>
        <zip>02169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Center</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Lou Ruvo Center for Brain Health</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princeton Medical Institute</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cognitive Research Center of New Jersey</name>
      <address>
        <city>Springfield</city>
        <state>New Jersey</state>
        <zip>07081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Specialists of Monmouth County</name>
      <address>
        <city>West Long Branch</city>
        <state>New Jersey</state>
        <zip>07764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Neuroscience</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Disease Research &amp; Neurology Center of Neurological Associates of Albany</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</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>Spri Clinicaltrials, Llc</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Hudson Medical Research</name>
      <address>
        <city>New Windsor</city>
        <state>New York</state>
        <zip>12553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ANI Neurology, PLLC dba Alzheimer's Memory Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insight Clinical Trials, LLC</name>
      <address>
        <city>Beachwood</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Diagnostics Inc.</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Health Center at Summit Research Network</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeastern Pennsylvania Memory and Alzheimer's Center</name>
      <address>
        <city>Plains</city>
        <state>Pennsylvania</state>
        <zip>18507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senior Adults Specialty Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerwin Research Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Consultants of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Department of Neurology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Adult Neurology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Recognition Health</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Alzheimer's Disease Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin, Inc.</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Brabois</name>
      <address>
        <city>Toulouse</city>
        <state>Cedex</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Ressources Biologiques</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital La Timone, Department of Neurology and Neuropsychology</name>
      <address>
        <city>Marseille Cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Gériatrie</name>
      <address>
        <city>Nice</city>
        <zip>6100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Nancy Hôpital de Brabois Service de Gériatrie</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 GN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PreCare Trial &amp; Recruitment</name>
      <address>
        <city>Beek</city>
        <zip>6191 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center Den Bosch B.V.</name>
      <address>
        <city>Den Bosch</city>
        <zip>5223 LA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Research Center Zwolle</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Specjalistyczna Praktyka Lekarska</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-438</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS</name>
      <address>
        <city>Katowice</city>
        <zip>40-123</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowska Akademia Neurologii</name>
      <address>
        <city>Kraków</city>
        <zip>31-505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEURO-CARE Sp. z o.o. Sp. Komandytowa</name>
      <address>
        <city>Siemianowice Śląskie</city>
        <zip>41-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedis Sp. z o.o.</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne NeuroProtect</name>
      <address>
        <city>Warszawa</city>
        <zip>01-684</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ Wrocławskie Centrum Alzheimerowskie</name>
      <address>
        <city>Wrocław</city>
        <zip>53-659</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica Gipuzkoa</name>
      <address>
        <city>San Sebastián</city>
        <state>Gipuzkoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>8005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacio Ace</name>
      <address>
        <city>Barcelona</city>
        <zip>8028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari General de Catalunya</name>
      <address>
        <city>Sant Cugat Del Vallès</city>
        <zip>8195</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognition Health Birmingham (private)</name>
      <address>
        <city>Edgbaston</city>
        <state>Birmingham</state>
        <zip>B16 8LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Pancras Clinical Research (private)</name>
      <address>
        <city>Barbican</city>
        <state>London</state>
        <zip>EC2Y 8EA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognition Health Plymouth</name>
      <address>
        <city>Plymouth</city>
        <state>Science Park</state>
        <zip>PL5 8BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memory Assessment and Research Centre, Moorgreen Hospital</name>
      <address>
        <city>Southampton</city>
        <state>UK</state>
        <zip>SO30 3JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RICE - The Research Institute for the Care of Older People</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</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>Cognition Health Ltd. (private) Guildford</name>
      <address>
        <city>Guildford</city>
        <zip>GU2 7YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cognition Health Ltd. (private) London</name>
      <address>
        <city>London</city>
        <zip>W1G 9JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingshill Research Centre Swindon</name>
      <address>
        <city>Swindon</city>
        <zip>SN3 6BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>December 23, 2022</results_first_submitted>
  <results_first_submitted_qc>February 22, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2023</results_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>May 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03823404/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 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03823404/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 89 centers worldwide screened subjects and included 57 centers in the United States, 9 centers in the United Kingdom, 8 centers in Spain, 7 centers in Poland, 5 centers in France, and 3 centers in the Netherlands.</recruitment_details>
      <pre_assignment_details>Randomized subjects were stratified by baseline Mini-Mental State Examination (MMSE) score (MMSE ≥12 and ≤18, and MMSE ≥19 and ≤24) and Apolipoprotein E genotype (ApoE4 positive either homozygous or heterozygous vs. all others) to assure balanced distribution of mild and moderate Alzheimer's disease and a balanced distribution of ApoE4 subjects, across treatment arms.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>COR388 80 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="P2">
          <title>COR388 40 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="P3">
          <title>Placebo BID (Twice Daily)</title>
          <description>Placebo capsule: BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="214"/>
                <participants group_id="P2" count="212"/>
                <participants group_id="P3" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="129"/>
                <participants group_id="P2" count="127"/>
                <participants group_id="P3" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="85"/>
                <participants group_id="P3" count="54"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other: Various reasons provided</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population</population>
      <group_list>
        <group group_id="B1">
          <title>COR388 80 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="B2">
          <title>COR388 40 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="B3">
          <title>Placebo BID (Twice Daily)</title>
          <description>Placebo capsule: BID</description>
        </group>
        <group group_id="B4">
          <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="214"/>
            <count group_id="B2" value="212"/>
            <count group_id="B3" value="217"/>
            <count group_id="B4" value="643"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age = age at consent</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.3" spread="6.9"/>
                    <measurement group_id="B2" value="68.6" spread="6.9"/>
                    <measurement group_id="B3" value="69.5" spread="6.9"/>
                    <measurement group_id="B4" value="69.1" spread="6.9"/>
                  </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="117"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="125"/>
                    <measurement group_id="B4" value="365"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="92"/>
                    <measurement group_id="B4" value="278"/>
                  </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="35"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="174"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="187"/>
                    <measurement group_id="B4" value="549"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="192"/>
                    <measurement group_id="B4" value="574"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="152"/>
                    <measurement group_id="B4" value="447"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)</title>
        <description>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)</title>
          <description>Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.</description>
          <population>Intent-to-Treat Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="211"/>
                    <count group_id="O3" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="8.8"/>
                    <measurement group_id="O2" value="23.4" spread="8.6"/>
                    <measurement group_id="O3" value="23.6" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of Weeks 40/48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="148"/>
                    <count group_id="O3" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="12.0"/>
                    <measurement group_id="O2" value="27.9" spread="11.8"/>
                    <measurement group_id="O3" value="28.4" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0455</p_value>
            <p_value_desc>The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.</p_value_desc>
            <method>mixed-effects model for repeated measure</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)</title>
        <description>The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.&#xD;
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)</title>
          <description>The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.&#xD;
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.</description>
          <population>Intent-to-Treat Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="211"/>
                    <count group_id="O3" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.9" spread="11.2"/>
                    <measurement group_id="O2" value="60.1" spread="11.3"/>
                    <measurement group_id="O3" value="60.4" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of Weeks 40/48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4" spread="13.9"/>
                    <measurement group_id="O2" value="54.4" spread="13.7"/>
                    <measurement group_id="O3" value="55.5" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0455</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Dementia Rating-Sum of Boxes (CDR-SB)</title>
        <description>Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.&#xD;
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Dementia Rating-Sum of Boxes (CDR-SB)</title>
          <description>Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.&#xD;
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.</description>
          <population>Intent-to-Treat Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="211"/>
                    <count group_id="O3" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.6"/>
                    <measurement group_id="O2" value="6.0" spread="2.7"/>
                    <measurement group_id="O3" value="5.9" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of Weeks 40/48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="3.6"/>
                    <measurement group_id="O2" value="7.2" spread="3.4"/>
                    <measurement group_id="O3" value="7.4" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mini-Mental State Examination (MMSE)</title>
        <description>Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Mini-Mental State Examination (MMSE)</title>
          <description>Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome</description>
          <population>Intent-to-Treat Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="212"/>
                    <count group_id="O3" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="3.3"/>
                    <measurement group_id="O2" value="18.4" spread="3.2"/>
                    <measurement group_id="O3" value="18.2" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of Week 40/48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="149"/>
                    <count group_id="O3" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="5.7"/>
                    <measurement group_id="O2" value="16.4" spread="5.7"/>
                    <measurement group_id="O3" value="16.2" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Neuropsychiatric Inventory (NPI)</title>
        <description>Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.&#xD;
Total score ranges from 12 to 144; higher scores indicate greater disease severity.</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Neuropsychiatric Inventory (NPI)</title>
          <description>Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.&#xD;
Total score ranges from 12 to 144; higher scores indicate greater disease severity.</description>
          <population>Intent-to-Treat Population</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="216"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="212"/>
                    <count group_id="O3" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="8.7"/>
                    <measurement group_id="O2" value="8.2" spread="11.2"/>
                    <measurement group_id="O3" value="8.1" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average of Weeks 40/48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="142"/>
                    <count group_id="O3" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="13.7"/>
                    <measurement group_id="O2" value="9.2" spread="12.1"/>
                    <measurement group_id="O3" value="10.4" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Anti-P. Gingivalis IgG in Serum</title>
        <description>Anti-P. gingivalis immunoglobulin G (IgG) in serum&#xD;
Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)&#xD;
Lower levels represent a pharmacodynamic effect of the drug on its target</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-P. Gingivalis IgG in Serum</title>
          <description>Anti-P. gingivalis immunoglobulin G (IgG) in serum&#xD;
Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)&#xD;
Lower levels represent a pharmacodynamic effect of the drug on its target</description>
          <population>Intent-to-Treat Population</population>
          <units>EU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="209"/>
                    <count group_id="O3" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191.6" spread="216.8"/>
                    <measurement group_id="O2" value="202.4" spread="214.0"/>
                    <measurement group_id="O3" value="193.1" spread="199.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="130"/>
                    <count group_id="O2" value="131"/>
                    <count group_id="O3" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" spread="123.2"/>
                    <measurement group_id="O2" value="110.8" spread="184.3"/>
                    <measurement group_id="O3" value="134.4" spread="201.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Magnetic Resonance Imaging</title>
        <description>Change in magnetic resonance imaging - bilateral whole brain volume&#xD;
Larger volume may represent effect of the drug on its target</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Magnetic Resonance Imaging</title>
          <description>Change in magnetic resonance imaging - bilateral whole brain volume&#xD;
Larger volume may represent effect of the drug on its target</description>
          <population>Intent-to-Treat Population</population>
          <units>volume (CM^3)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="212"/>
                <count group_id="O3" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="199"/>
                    <count group_id="O3" value="202"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1005154" spread="106682"/>
                    <measurement group_id="O2" value="1008135" spread="105765"/>
                    <measurement group_id="O3" value="1001711" spread="111145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="982782" spread="111888"/>
                    <measurement group_id="O2" value="987998" spread="102961"/>
                    <measurement group_id="O3" value="986119" spread="111779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Periodontal (or Gum) Pocket Depth</title>
        <description>Periodontal (or gum) pocket depth - pocket depth for only sites with depth &gt;= 4mm.&#xD;
The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.&#xD;
Larger measure means worse outcome</description>
        <time_frame>Baseline to Week 48</time_frame>
        <population>Intent-to-Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>COR388 80 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O2">
            <title>COR388 40 mg BID (Twice Daily)</title>
            <description>COR388 capsule: BID</description>
          </group>
          <group group_id="O3">
            <title>Placebo BID (Twice Daily)</title>
            <description>Placebo capsule: BID</description>
          </group>
        </group_list>
        <measure>
          <title>Periodontal (or Gum) Pocket Depth</title>
          <description>Periodontal (or gum) pocket depth - pocket depth for only sites with depth &gt;= 4mm.&#xD;
The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.&#xD;
Larger measure means worse outcome</description>
          <population>Intent-to-Treat Population</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.04" spread="0.75"/>
                    <measurement group_id="O2" value="4.03" spread="0.59"/>
                    <measurement group_id="O3" value="3.74" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread="0.92"/>
                    <measurement group_id="O2" value="3.78" spread="0.71"/>
                    <measurement group_id="O3" value="3.57" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>COR388 80 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="E2">
          <title>COR388 40 mg BID (Twice Daily)</title>
          <description>COR388 capsule: BID</description>
        </group>
        <group group_id="E3">
          <title>Placebo BID (Twice Daily)</title>
          <description>Placebo capsule: BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="5" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>gastric perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>general physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>cholecystitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>abdominal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>multiple fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>liver function test abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>foot deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>gastrointestinal cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>lung cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>prostate cancer stage II</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>dementia Alzheimer's type</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>aggression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>anxiety disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>hallucination</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>intentional self-injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>psychotic behaviour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>renal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="214"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="212"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</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="139" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="150" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="88" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>fall</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALT increased</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>AST increased</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>agitation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="214"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="212"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="217"/>
              </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>Individual investigators and/or their associates may publish findings of this study in scientific journals or present them at scientific meetings, provided the Sponsor is given ample opportunity to review any proposed abstract, manuscript, or slide presentation before its submission.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Karen Smith</name_or_title>
      <organization>Quince Therapeutics, Inc.</organization>
      <phone>650 722 9813</phone>
      <email>ksmith@quincetx.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/NCT03823404
org study id: COR388-010
nct id: NCT03823404
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled study that assessed the efficacy,
      safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of
      mild to moderate Alzheimer's disease (AD) dementia.
This was a randomized, double-blind, placebo-controlled study that assessed the efficacy,
      safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable
      Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's
      Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging
      abnormalities that could explain the symptoms of dementia. All subjects were encouraged to
      have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical
      conditions that could increase the risk of the procedure in the opinion of the Investigator.
      Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of
      AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of
      Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical
      evidence of periodontitis at baseline, 24 and 48 weeks.

      The study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up
      to 48 weeks, and a safety follow-up phase of 6 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)
time frame: Baseline to Week 48
description: Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.
measure: Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)
time frame: Baseline to Week 48
description: The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.
The ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.
measure: Clinical Dementia Rating-Sum of Boxes (CDR-SB)
time frame: Baseline to Week 48
description: Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
measure: Mini-Mental State Examination (MMSE)
time frame: Baseline to Week 48
description: Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome
measure: Neuropsychiatric Inventory (NPI)
time frame: Baseline to Week 48
description: Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.
Total score ranges from 12 to 144; higher scores indicate greater disease severity.
measure: Anti-P. Gingivalis IgG in Serum
time frame: Baseline to Week 48
description: Anti-P. gingivalis immunoglobulin G (IgG) in serum
Antibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)
Lower levels represent a pharmacodynamic effect of the drug on its target
measure: Magnetic Resonance Imaging
time frame: Baseline to Week 48
description: Change in magnetic resonance imaging - bilateral whole brain volume
Larger volume may represent effect of the drug on its target
measure: Periodontal (or Gum) Pocket Depth
time frame: Baseline to Week 48
description: Periodontal (or gum) pocket depth - pocket depth for only sites with depth >= 4mm.
The primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.
Larger measure means worse outcome
arm group label: COR388 80 mg twice daily (BID)
arm group type: Experimental
description: COR388 hydrochloric acid (HCl), 80 mg orally administered capsule, BID (twice daily) with water approximately 12 hours apart and no less than 6 hours apart
arm group label: COR388 40 mg BID
arm group type: Experimental
description: COR388 HCl, 40 mg orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart
arm group label: Placebo BID
arm group type: Placebo Comparator
description: Placebo orally administered capsule, BID with water approximately 12 hours apart and no less than 6 hours apart
intervention type: Drug
intervention name: COR388 capsule
description: BID (twice daily)
arm group label: COR388 40 mg BID
arm group label: COR388 80 mg twice daily (BID)
other name: atuzaginstat
intervention type: Drug
intervention name: Placebo capsule
description: BID
arm group label: Placebo BID
other name: atuzaginstat
criteria: 
gender: All
gender based: Yes
gender description: Male and female.
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Karen Smith, MD
role: Study Director
affiliation: Quince Therapeutics Inc
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country: France
country: Netherlands
country: Poland
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No
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