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Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Primary Purpose

Psychosis Associated With Alzheimer's Disease

Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KarXT
Sponsored by
Karuna Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Must have completed study KAR-031. Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031 study. Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, provide assent and the subject's legally acceptable representative or study partner/caregiver, if local regulations allow, must provide informed consent before any study assessments are performed. At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study. Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject). Key Exclusion Criteria: Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject. Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KarXT

Arm Description

Xanomeline and Trospium Chloride Capsules

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)
The number and percentage of participants with TEAEs will be determined

Secondary Outcome Measures

Incidence of serious TEAEs
The number and percentage of participants with serious TEAEs will be determined
Incidence of TEAEs leading to withdrawal
The number and percentage of participants with TEAEs leading to withdrawal will be determined

Full Information

First Posted
July 31, 2023
Last Updated
August 31, 2023
Sponsor
Karuna Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05980949
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
Acronym
ADEPT-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karuna Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis Associated With Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KarXT
Arm Type
Experimental
Arm Description
Xanomeline and Trospium Chloride Capsules
Intervention Type
Drug
Intervention Name(s)
KarXT
Intervention 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)
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
The number and percentage of participants with TEAEs will be determined
Time Frame
From initial dose through 14 days after the final dose (up to 54 weeks)
Secondary Outcome Measure Information:
Title
Incidence of serious TEAEs
Description
The number and percentage of participants with serious TEAEs will be determined
Time Frame
From initial dose through 14 days after the final dose (up to 54 weeks)
Title
Incidence of TEAEs leading to withdrawal
Description
The number and percentage of participants with TEAEs leading to withdrawal will be determined
Time Frame
From initial dose through 14 days after the final dose (up to 54 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have completed study KAR-031. Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031 study. Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, provide assent and the subject's legally acceptable representative or study partner/caregiver, if local regulations allow, must provide informed consent before any study assessments are performed. At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study. Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject). Key Exclusion Criteria: Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject. Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Yeung, MD, MPH
Organizational Affiliation
Karuna Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease

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