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Psychosis Associated With Alzheimer's DiseaseDrugPhase 3

What this study is

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. 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.

What's being tested

  • KarXT

    Intervention · DRUG

    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)

Study details

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions
Psychosis Associated With Alzheimer's Disease
Enrolling
1,000 people
Starts
2023-07-11
Est. completion
2027-09-07
Design
Open-label, single group, Phase 3
Record
View on ClinicalTrials.gov ↗