Phase 3RecruitingAge-related condition
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)
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company (Industry)
- Enrolment
- 1,000 planned
- Conditions
- Psychosis Associated With Alzheimer's Disease
- Interventions
- KarXT
- Ages
- adults, older adults
- Registry
- NCT05980949, CTIS2023-504151-27-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Incidence of treatment-emergent adverse events (TEAEs)
History
Primary completion expected
Last registry update
Registered
Started