Clinical Trial

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)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 changes
notable Enrollment increased: 800 -> 1000 participants 2026-07-07
notable Trial sites expanded: 421 -> 426 locations 2026-06-03
notable Trial sites expanded: 416 -> 421 locations 2026-05-13
notable Trial sites expanded: 412 -> 415 locations 2026-04-07
notable Sponsor changed: Karuna Therapeutics -> Karuna Therapeutics, Inc., a Bristol Myers Squibb company 2026-03-29
Trial Details
NCT Number NCT05980949
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Psychosis Associated With Alzheimer's Disease
Enrollment 1,000 participants
Start Date 2023-07-11
Primary Completion 2027-09-07 (estimated)
Study Completion 2027-09-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-06