A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

NCT Number	NCT05511363
Lead Sponsor	Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions	Psychosis Associated With Alzheimer's Disease
Enrollment	410 participants
Start Date	2022-08-23
Primary Completion	2026-10-05 (estimated)
Study Completion	2026-10-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-14