<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/NCT01676935</url>
  </required_header>
  <id_info>
    <org_study_id>M11-427</org_study_id>
    <secondary_id>2011-004780-75</secondary_id>
    <nct_id>NCT01676935</nct_id>
  </id_info>
  <brief_title>This is a 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 Subjects With Mild-to-Moderate Alzheimer's Disease: An Open-Label Extension Study for Subjects Completing Study M10-985</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 M10-985 which is evaluating a new treatment for subjects with mild to moderate&#xD;
      Alzheimer's disease.&#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;
      M10-985. Up to 410 subjects may participate at approximately 30 sites in several countries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Data obtained from the M11-427 study is not critical to the continued evaluation of ABT-126.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 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">349</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 must&#xD;
        be obtained from the subject's representative and assent must be obtained from the subject.&#xD;
        - The subject was randomized into Study M10-985 and completed dosing through Week 24 in&#xD;
        that study. - With the exception of a diagnosis of mild to moderate AD and the presence of&#xD;
        stable 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 ECG.&#xD;
        - If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using&#xD;
        a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository&#xD;
        for the duration of the study and for 30 days following the last dose of study drug.&#xD;
        However, if the male subject's partner has been postmenopausal for at least 2 years or is&#xD;
        surgically sterile, then use of a barrier method of birth control is not required. - The&#xD;
        subject has an identified, reliable caregiver who will provide support and ensure&#xD;
        compliance with the study medication and procedures, and provide accurate information about&#xD;
        the subject's status during the study. - The subject and caregiver must have sufficient&#xD;
        visual, hearing and graphomotor skills to complete the study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Experienced an adverse event or abnormal finding in physical examination, vital signs,&#xD;
        laboratory profile and/or ECG measurements in Study M10-985 that indicates the subject&#xD;
        could become medically unstable during the current study. - The subject is currently taking&#xD;
        or is expected to be prescribed any excluded medications (including acetylcholinesterase&#xD;
        inhibitors or memantine), without the approval of Abbott medical monitor. - The subject&#xD;
        anticipates a move outside the geographic area of the investigative site or is planning&#xD;
        extended travel inconsistent with the recommended visit intervals. - The subject is&#xD;
        currently enrolled in, or plans to participate in, another experimental study during the&#xD;
        course of this trial. - The subject developed any significant medical or psychiatric&#xD;
        condition that, in the opinion of the investigator, renders the subject an unsuitable&#xD;
        candidate to participate in this study. - For any other reason the investigator considers&#xD;
        the subject to be an unsuitable candidate to receive ABT-126 or to participate in this&#xD;
        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# 73493</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# 73496</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# 73495</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# 73494</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# 97035</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73514</name>
      <address>
        <city>Poznan</city>
        <zip>61-853</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73515</name>
      <address>
        <city>Szczecin</city>
        <zip>71-215</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73516</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73525</name>
      <address>
        <city>Kazan</city>
        <zip>420097</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73523</name>
      <address>
        <city>Kirov</city>
        <zip>610014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73521</name>
      <address>
        <city>Moscow</city>
        <zip>119048</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73519</name>
      <address>
        <city>Moscow</city>
        <zip>123995</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73517</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630064</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73520</name>
      <address>
        <city>Saratov</city>
        <zip>410060</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73518</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73524</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84615</name>
      <address>
        <city>St. Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73522</name>
      <address>
        <city>St. Petersburg</city>
        <zip>198510</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73507</name>
      <address>
        <city>Belville</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 84614</name>
      <address>
        <city>Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73505</name>
      <address>
        <city>George</city>
        <zip>6529</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73506</name>
      <address>
        <city>Johannesburg</city>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73533</name>
      <address>
        <city>Donetsk</city>
        <zip>83037</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73534</name>
      <address>
        <city>Kiev</city>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73535</name>
      <address>
        <city>Poltava</city>
        <zip>36006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73502</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73503</name>
      <address>
        <city>Blackburn</city>
        <zip>BB2 3HH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73501</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 73504</name>
      <address>
        <city>London</city>
        <zip>TW8 8DS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.</citation>
    <PMID>27756421</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 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/NCT01676935
org study id: M11-427
secondary id: 2011-004780-75
nct id: NCT01676935
lead sponsor: 
has dmc: No
This is a long term extension study to evaluate safety and tolerability of subjects who
      complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate
      Alzheimer's disease.
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
      M10-985. Up to 410 subjects may participate at approximately 30 sites in several 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: Poland
country: Russian Federation
country: South Africa
country: Ukraine
country: United Kingdom
country: United States
citation: Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.
PMID: 27756421
responsible party type: Sponsor
mesh term: Alzheimer Disease