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

Study Overview
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Brief Summary
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This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study KAR-031 or KAR-032. Subjects (randomized or non-randomized) who complete the 38-week KAR-031 or KAR-032 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.

Official Title
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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

Conditions
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Psychosis Associated With Alzheimer's Disease

Intervention / Treatment
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* Drug: KarXT


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Must have completed study KAR-031 or KAR-032. Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031 or KAR-032 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 or KAR-032 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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KarXT<br>Xanomeline and Trospium Chloride Capsules | Drug: KarXT<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (TEAEs) | The number and percentage of participants with TEAEs will be determined | From initial dose through 14 days after the final dose (up to 54 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious TEAEs | The number and percentage of participants with serious TEAEs will be determined | From initial dose through 14 days after the final dose (up to 54 weeks) | 
| Incidence of TEAEs leading to withdrawal | The number and percentage of participants with TEAEs leading to withdrawal will be determined | From initial dose through 14 days after the final dose (up to 54 weeks) |