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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Psychosis Associated With Alzheimer's Disease

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

55 to 90 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last updated on ClinicalTrials.gov

August 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites