NCT05511363

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psychosis Associated With Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	KarXT	KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
DRUG	Placebo	Placebo Capsules

Timeline

• Start date: 2022-08-23
• Primary completion: 2026-10-05
• Completion: 2026-10-05
• First posted: 2022-08-23
• Last updated: 2026-03-24

Locations

116 sites across 11 countries: United States, Bulgaria, Croatia, Czechia, France, Germany, Italy, Serbia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study