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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
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
Conditions
Interventions
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
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