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

  1. Primary completion expected

  2. Last registry update

  3. Registered

  4. Started