ADEPT-3: Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KarXT Xanomeline and Trospium Chloride Capsules |
Drug: KarXT
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)
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [From initial dose through 14 days after the final dose (up to 54 weeks)]
The number and percentage of participants with TEAEs will be determined
Secondary Outcome Measures
- Incidence of serious TEAEs [From initial dose through 14 days after the final dose (up to 54 weeks)]
The number and percentage of participants with serious TEAEs will be determined
- Incidence of TEAEs leading to withdrawal [From initial dose through 14 days after the final dose (up to 54 weeks)]
The number and percentage of participants with TEAEs leading to withdrawal will be determined
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Trial Site | Lafayette | California | United States | 94549 |
Sponsors and Collaborators
- Karuna Therapeutics
Investigators
- Study Director: Paul Yeung, MD, MPH, Karuna Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KAR-033