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RECRUITING
NCT06947941
PHASE3

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

325

Start Date

2026-03-25

Completion Date

2028-03-20

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

DRUG

KarXT + KarX-EC Arm Matching Placebo

Specified dose on specified days

Locations (22)

Local Institution - 0042

Gilbert, Arizona, United States

Inland Psychiatric Medical Group.

Chino, California, United States

Local Institution - 0001

Naples, Florida, United States

Local Institution - 1401

Naples, Florida, United States

Local Institution - 0029

Cleveland, Ohio, United States

Local Institution - 0043

Shaker Heights, Ohio, United States

Local Institution - 0020

Macquarie Park, New South Wales, Australia

Local Institution - 0052

Nedlands, Western Australia, Australia

Local Institution - 0054

Toronto, Ontario, Canada

Local Institution - 0027

Whitby, Ontario, Canada

Local Institution - 0025

Montreal, Quebec, Canada

Local Institution - 0040

Suita, Osaka, Japan

Local Institution - 0035

Nankoku-shi, Japan

Local Institution - 0034

Osaka, Japan

Local Institution - 0005

Exeter, Devon, United Kingdom

Local Institution - 0018

Saint Leonards-on-Sea, East Sussex, United Kingdom

Local Institution - 0023

London, England, United Kingdom

Local Institution - 0015

Oxford, Oxfordshire, United Kingdom

Local Institution - 0009

Chertsey, Surrey, United Kingdom

Local Institution - 0017

Sheffield, Yorkshire and the Humber, United Kingdom

Local Institution - 0024

London, United Kingdom

Local Institution - 0004

Motherwell, United Kingdom