<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/NCT01690195</url>
  </required_header>
  <id_info>
    <org_study_id>M11-428</org_study_id>
    <secondary_id>2012-000537-39</secondary_id>
    <nct_id>NCT01690195</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease</brief_title>
  <official_title>Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a long term extension study to evaluate safety and tolerability of subjects who&#xD;
      complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate&#xD;
      Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term&#xD;
      safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study&#xD;
      M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory Data</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Assessments include pulse, blood pressure and oral body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical examinations</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>An examination of bodily functions and physical condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Neurological examination</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Psychiatric assessments</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>The scale is designed to assess suicidal behavior and ideation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cornell Scale for Depression in Dementia</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Assesses the signs and symptoms of major depression in patients with dementia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrocardiogram</measure>
    <time_frame>Assessments up through 28 weeks</time_frame>
    <description>Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">343</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>ABT-126</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-126 Open-label dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-126</intervention_name>
    <description>See arm description</description>
    <arm_group_label>ABT-126</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject and caregiver must voluntarily sign and date an informed consent. If the&#xD;
             subject does not have the capacity to provide informed consent, full informed consent&#xD;
             must be obtained from the subject's representative and assent must be obtained from&#xD;
             the subject.&#xD;
&#xD;
          -  The subject was randomized into Study M11-793 and completed dosing through Week 24 in&#xD;
             that study.&#xD;
&#xD;
          -  With the exception of a diagnosis of mild to moderate AD and the presence of stable&#xD;
             medical conditions, the subject is in general good health, based upon the results of&#xD;
             medical history, physical examination, vital signs, laboratory profile, and a 12-lead&#xD;
             ECG.&#xD;
&#xD;
          -  If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is&#xD;
             using a barrier method of birth control (condom) with spermicidal&#xD;
             foam/gel/film/cream/suppository for the duration of the study and for 30 days&#xD;
             following the last dose of study drug. However, if the male subject's partner has been&#xD;
             postmenopausal for at least two years or is surgically sterile, then use of a barrier&#xD;
             method of birth control is not required.&#xD;
&#xD;
          -  The subject has an identified, reliable caregiver who will provide support and ensure&#xD;
             compliance with the study medication and procedures, and provide accurate information&#xD;
             about the subject's status during the study.&#xD;
&#xD;
          -  The subject and caregiver must have sufficient visual, hearing and graphomotor skills&#xD;
             to complete the study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject experienced an adverse event or abnormal finding in physical examination,&#xD;
             vital signs, laboratory profile and/or ECG measurements in Study M11-793 that&#xD;
             indicates the subject could become medically unstable during the current study.&#xD;
&#xD;
          -  The subject is currently taking or is expected to be prescribed any excluded&#xD;
             medications without the approval of Abbott medical monitor.&#xD;
&#xD;
          -  The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is&#xD;
             expected to discontinue these medications prior to conclusion of this study.&#xD;
&#xD;
          -  The subject anticipates a move outside the geographic area of the investigative site&#xD;
             or is planning extended travel inconsistent with the recommended visit intervals.&#xD;
&#xD;
          -  The subject is currently enrolled in, or plans to participate in, another experimental&#xD;
             study during the course of this trial.&#xD;
&#xD;
          -  The subject developed any significant medical or psychiatric condition that, in the&#xD;
             opinion of the investigator, renders the subject an unsuitable candidate to&#xD;
             participate in this study.&#xD;
&#xD;
          -  For any other reason the investigator considers the subject to be an unsuitable&#xD;
             candidate to receive ABT-126 or to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Gault, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84185</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84183</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109-4841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84187</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84178</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84180</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84186</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84182</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84181</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84179</name>
      <address>
        <city>Bennington</city>
        <state>Vermont</state>
        <zip>05201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84173</name>
      <address>
        <city>Gatineau</city>
        <zip>J9A 1K7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84174</name>
      <address>
        <city>Montreal</city>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84177</name>
      <address>
        <city>Peterborough</city>
        <zip>K9H 2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84175</name>
      <address>
        <city>Toronto</city>
        <zip>M3B 2S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84176</name>
      <address>
        <city>Verdun</city>
        <zip>H4H 1R3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84376</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84373</name>
      <address>
        <city>Limoges Cedex</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84374</name>
      <address>
        <city>Paris Cedex 10</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84377</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84375</name>
      <address>
        <city>Toulouse Cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84382</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84380</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84383</name>
      <address>
        <city>Huettenberg</city>
        <zip>35625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84379</name>
      <address>
        <city>Mittweida</city>
        <zip>09648</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84381</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84378</name>
      <address>
        <city>Schwerin</city>
        <zip>19053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84385</name>
      <address>
        <city>Athens</city>
        <zip>115 21</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84388</name>
      <address>
        <city>Athens</city>
        <zip>151 25</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84389</name>
      <address>
        <city>Athens</city>
        <zip>15123</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84386</name>
      <address>
        <city>Haidari, Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84390</name>
      <address>
        <city>Thessaloniki</city>
        <zip>570 10</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84395</name>
      <address>
        <city>Belville</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84391</name>
      <address>
        <city>Cape Town</city>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84393</name>
      <address>
        <city>George</city>
        <zip>6529</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84394</name>
      <address>
        <city>Johannesburg</city>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84392</name>
      <address>
        <city>Rosebank</city>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84398</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84397</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84400</name>
      <address>
        <city>London</city>
        <zip>TW8 8DS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84399</name>
      <address>
        <city>Manchester</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>South Africa</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.</citation>
    <PMID>26967214</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01690195
org study id: M11-428
secondary id: 2012-000537-39
nct id: NCT01690195
lead sponsor: 
has dmc: No
This is a long term extension study to evaluate safety and tolerability of subjects who
      complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate
      Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term
      safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study
      M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: Assessments up through 28 weeks
description: Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
measure: Laboratory Data
time frame: Assessments up through 28 weeks
description: Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
measure: Vital Signs
time frame: Assessments up through 28 weeks
description: Assessments include pulse, blood pressure and oral body temperature
measure: Physical examinations
time frame: Assessments up through 28 weeks
description: An examination of bodily functions and physical condition
measure: Brief Neurological examination
time frame: Assessments up through 28 weeks
description: Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
measure: Brief Psychiatric assessments
time frame: Assessments up through 28 weeks
description: Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
measure: Columbia-Suicide Severity Rating Scale
time frame: Assessments up through 28 weeks
description: The scale is designed to assess suicidal behavior and ideation
measure: Cornell Scale for Depression in Dementia
time frame: Assessments up through 28 weeks
description: Assesses the signs and symptoms of major depression in patients with dementia
measure: Electrocardiogram
time frame: Assessments up through 28 weeks
description: Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
arm group label: ABT-126
arm group type: Experimental
description: ABT-126 Open-label dose
intervention type: Drug
intervention name: ABT-126
description: See arm description
arm group label: ABT-126
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Laura Gault, MD
role: Study Director
affiliation: AbbVie
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country: Canada
country: France
country: Germany
country: Greece
country: South Africa
country: United Kingdom
country: United States
citation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.
PMID: 26967214
responsible party type: Sponsor
mesh term: Alzheimer Disease