Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 29, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT05980949). This is a study registration, not published results. Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Psychosis Associated With Alzheimer's Disease. Interventions: DRUG: KarXT. Primary outcome measures: Incidence of treatment-emergent adverse events (TEAEs) , From initial dose through 14 days after the final dose (up to 54 weeks). Brief 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.