<clinical_study>
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  <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/NCT02192554</url>
  </required_header>
  <id_info>
    <org_study_id>331-13-211</org_study_id>
    <nct_id>NCT02192554</nct_id>
  </id_info>
  <brief_title>Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo</brief_title>
  <official_title>A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To follow-up on the safety of subjects who were previously treated in a double-blind trial of&#xD;
      brexpiprazole.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's&#xD;
      disease and related dementias, and develop in the majority of dementia subjects. The presence&#xD;
      of agitation in subjects with Alzheimer's disease places a significant burden not only on&#xD;
      subjects and their caregivers but also on the healthcare system.&#xD;
&#xD;
      This is a trial designed to assess the ongoing safety of subjects with agitation associated&#xD;
      with dementia of the Alzheimer's type after completing a 12-week double-blind trial of&#xD;
      brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in&#xD;
      the safety follow-up trial. The trial consists of a continuous 2 month observation period.&#xD;
      The trial population will include male and female subjects with a diagnosis of probable&#xD;
      Alzheimer's disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>Baseline to Month 2/Early Termination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mini-Mental State Examination (MMSE) score</measure>
    <time_frame>Baseline to Month 2/Early Termination</time_frame>
  </primary_outcome>
  <enrollment type="Actual">450</enrollment>
  <condition>Agitation Associated With Alzheimer's Disease</condition>
  <condition>Alzheimer's Type</condition>
  <condition>Mental Disorder</condition>
  <condition>Nervous System Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects must have completed a previous double-blind trial of brexpiprazole or placebo;&#xD;
        neither drug or placebo will be administered in the trial&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The investigator must assess the capacity of the subject to provide informed consent&#xD;
             prior to enrollment and throughout the trial.&#xD;
&#xD;
          -  Male and female subjects who completed both the 12-week double-blind treatment period&#xD;
             and the 30-day safety follow-up visit of the previous brexpiprazole trial.&#xD;
&#xD;
          -  Subject has an identified caregiver who is usually assigned to care for the subject on&#xD;
             a regular basis, has sufficient contact to describe the subject's symptoms, and has&#xD;
             direct observation of the subject's behavior.&#xD;
&#xD;
          -  Subject is able to comply with the protocol requirements.&#xD;
&#xD;
        Exclusion Criterion:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, medical monitor, or sponsor should&#xD;
             not participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Kohegyi, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tuscaloosa</city>
        <state>Alabama</state>
        <zip>35404</zip>
        <country>United States</country>
      </address>
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        <state>California</state>
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        <country>United States</country>
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        <state>California</state>
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    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>April 27, 2018</last_update_submitted>
  <last_update_submitted_qc>April 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>OPC-34712</keyword>
  <keyword>brexpiprazole</keyword>
  <keyword>Dementia</keyword>
  <keyword>Alzheimer's Disease</keyword>
  <keyword>Cognitive Disorders</keyword>
  <keyword>Memory</keyword>
  <keyword>Agitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Mental Disorders</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/NCT02192554
org study id: 331-13-211
nct id: NCT02192554
lead sponsor: 
collaborator: 
has dmc: Yes
To follow-up on the safety of subjects who were previously treated in a double-blind trial of
      brexpiprazole.
Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's
      disease and related dementias, and develop in the majority of dementia subjects. The presence
      of agitation in subjects with Alzheimer's disease places a significant burden not only on
      subjects and their caregivers but also on the healthcare system.

      This is a trial designed to assess the ongoing safety of subjects with agitation associated
      with dementia of the Alzheimer's type after completing a 12-week double-blind trial of
      brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in
      the safety follow-up trial. The trial consists of a continuous 2 month observation period.
      The trial population will include male and female subjects with a diagnosis of probable
      Alzheimer's disease.
observational model: Other
time perspective: Prospective
measure: Adverse Events (AEs)
time frame: Baseline to Month 2/Early Termination
measure: Mini-Mental State Examination (MMSE) score
time frame: Baseline to Month 2/Early Termination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eva Kohegyi, MD, MS
role: Study Director
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
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country: Bulgaria
country: Canada
country: Croatia
country: France
country: Germany
country: Russian Federation
country: Serbia
country: Slovenia
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Psychomotor Agitation
mesh term: Nervous System Diseases
mesh term: Mental Disorders