xml: <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/NCT05980949</url>
    </required_header>
    <id_info>
      <org_study_id>KAR-033</org_study_id>
      <nct_id>NCT05980949</nct_id>
    </id_info>
    <brief_title>Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease</brief_title>
    <acronym>ADEPT-3</acronym>
    <official_title>A Phase 3 Global, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Karuna Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Karuna Therapeutics</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 Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for&#xD;
        subjects completing study KAR-031. Subjects (randomized or non-randomized) who complete the&#xD;
        38-week KAR-031 study will be eligible to enroll in KAR-033.&#xD;
  &#xD;
        The primary objective of the study is to assess the long-term safety and tolerability of&#xD;
        KarXT in subjects with psychosis associated with Alzheimer's Disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2026</primary_completion_date>
    <phase>Phase 3</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>Incidence of treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>From initial dose through 14 days after the final dose (up to 54 weeks)</time_frame>
      <description>The number and percentage of participants with TEAEs will be determined</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious TEAEs</measure>
      <time_frame>From initial dose through 14 days after the final dose (up to 54 weeks)</time_frame>
      <description>The number and percentage of participants with serious TEAEs will be determined</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of TEAEs leading to withdrawal</measure>
      <time_frame>From initial dose through 14 days after the final dose (up to 54 weeks)</time_frame>
      <description>The number and percentage of participants with TEAEs leading to withdrawal will be determined</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Psychosis Associated With Alzheimer's Disease</condition>
    <arm_group>
      <arm_group_label>KarXT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Xanomeline and Trospium Chloride Capsules</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KarXT</intervention_name>
      <description>KarXT 20/2 mg TID (total daily dose [TDD] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)</description>
      <arm_group_label>KarXT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Must have completed study KAR-031.&#xD;
  &#xD;
            -  Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent&#xD;
               KAR-031 study.&#xD;
  &#xD;
            -  Can understand the nature of the study and protocol requirements and provide a signed&#xD;
               informed consent or, if deemed not competent to provide informed consent, provide&#xD;
               assent and the subject's legally acceptable representative or study partner/caregiver,&#xD;
               if local regulations allow, must provide informed consent before any study assessments&#xD;
               are performed.&#xD;
  &#xD;
            -  At entry into this study, or any time during the study, if a subject needs to relocate&#xD;
               from home or residential assisted-living facility to a nursing home facility, the&#xD;
               Sponsor/Medical Monitor must approve the subject's participation in the study.&#xD;
  &#xD;
            -  Have an identified or proxy caregiver (spends approximately 10 hours/week with the&#xD;
               subject).&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Significant or severe medical conditions that, in the opinion of the Investigator,&#xD;
               could jeopardize the safety of the subject, ability to complete or comply with the&#xD;
               study procedures or validity of the study results.&#xD;
  &#xD;
            -  Clinically significant abnormalities, including any finding(s) from the ECG,&#xD;
               laboratory tests, physical examination, or vital signs, at the EOT visit of Study&#xD;
               KAR-031 that the Investigator, in consultation with the Medical Monitor, are&#xD;
               considered to jeopardize the safety of the subject.&#xD;
  &#xD;
            -  Subjects participating in another investigational drug or device study or planning on&#xD;
               participating in another clinical study during the duration of KAR-033.&#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>Paul Yeung, MD, MPH</last_name>
      <role>Study Director</role>
      <affiliation>Karuna Therapeutics, Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Clinical Trial Site</name>
        <address>
          <city>Lafayette</city>
          <state>California</state>
          <zip>94549</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clinical Trial Site</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33155</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980949
  org study id: KAR-033
  nct id: NCT05980949
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for
        subjects completing study KAR-031. Subjects (randomized or non-randomized) who complete the
        38-week KAR-031 study will be eligible to enroll in KAR-033.
  
        The primary objective of the study is to assess the long-term safety and tolerability of
        KarXT in subjects with psychosis associated with Alzheimer's Disease.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of treatment-emergent adverse events (TEAEs)
  time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
  description: The number and percentage of participants with TEAEs will be determined
  measure: Incidence of serious TEAEs
  time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
  description: The number and percentage of participants with serious TEAEs will be determined
  measure: Incidence of TEAEs leading to withdrawal
  time frame: From initial dose through 14 days after the final dose (up to 54 weeks)
  description: The number and percentage of participants with TEAEs leading to withdrawal will be determined
  arm group label: KarXT
  arm group type: Experimental
  description: Xanomeline and Trospium Chloride Capsules
  intervention type: Drug
  intervention name: KarXT
  description: KarXT 20/2 mg TID (total daily dose [TDD] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
  arm group label: KarXT
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Paul Yeung, MD, MPH
  role: Study Director
  affiliation: Karuna Therapeutics, Inc.
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders