RecruitingPhase 3NCT06947941

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

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

Sponsor

Bristol-Myers Squibb

Enrollment

325 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease Psychosis

Summary

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

Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KarX-EC, a drug called KarXT, and others for people with alzheimer disease and psychosis. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 55 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

DRUGKarX-EC

Specified dose on specified days

DRUGKarXT + KarX-EC Arm Matching Placebo

Specified dose on specified days

Locations(22)

Gilbert Neurology Partners/CCT Research

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

Insight Clinical Trials LLC - Independence

Independence, 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 - 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 - 0018

Crowborough, United Kingdom

Local Institution - 0024

London, United Kingdom

Local Institution - 0004

Motherwell, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06947941

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