Clinical Trial

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Protocol Amendment History 5 changes
notable Trial sites expanded: 289 -> 292 locations 2026-07-08
notable Trial sites expanded: 281 -> 288 locations 2026-05-01
notable Primary completion pushed: 2026-09-21 -> 2026-11-24 2026-05-01
minor Completion pushed: 2026-10-19 -> 2026-12-22 2026-05-01
notable Sponsor changed: Karuna Therapeutics -> Karuna Therapeutics, Inc., a Bristol Myers Squibb company 2026-03-29
Trial Details
NCT Number NCT06585787
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Alzheimer Disease
Enrollment 406 participants
Start Date 2024-09-26
Primary Completion 2026-11-24 (estimated)
Study Completion 2026-12-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-30