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

Phase 3

Recruiting

• Conditions: Psychosis Associated With Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: KarXT

• Registration Number: NCT05511363
• Lead Sponsor: Karuna Therapeutics

Brief 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 and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study Start: 2022-08-23
• Study First Posted: 2022-08-23
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-09
• Last Update Posted: 2025-10-10
• Primary Completion: 2026-10-05
• Study Completion: 2026-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Capsules
KarXT	KarXT	Xanomeline and Trospium Chloride Capsules

Primary Outcome Measures

Name	Time	Method
Time from randomization to relapse during the 38-week study	Week 38

Secondary Outcome Measures

Name	Time	Method
Time from randomization to discontinuation for any reason during the 38-week study	Week 38

Trial Locations

Locations (113)

Local Institution - 1029; 🇺🇸 Homewood, Alabama, United States

Local Institution - 1044; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 1033; 🇺🇸 Encino, California, United States

Local Institution - 1031; 🇺🇸 Irvine, California, United States

ATP Clinical Research-302 W La Veta Ave; 🇺🇸 Orange, California, United States

Local Institution - 1043; 🇺🇸 Pasadena, California, United States

Local Institution - 1047; 🇺🇸 San Marcos, California, United States

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS; 🇺🇸 Walnut Creek, California, United States

Local Institution - 1014; 🇺🇸 Colorado Springs, Colorado, United States

Local Institution - 1013; 🇺🇸 Stamford, Connecticut, United States

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