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
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.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup. * Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg,…
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 (20)
- Local Institution - 0042Gilbert, Arizona
- Inland Psychiatric Medical Group.Chino, California
- Local Institution - 0001Naples, Florida
- Local Institution - 1401Naples, Florida
- Local Institution - 0043Shaker Heights, Ohio
- Local Institution - 0020Macquarie Park, New South Wales