A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient 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, major stroke, neoplasm, subdural hematoma. * Patient must…
Interventions
- DrugKarXT
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (288)
- Chandler Clinical Trials, LLCChandler, Arizona
- Gilbert Neurology Partners - PLLC - AvacareGilbert, Arizona
- Banner Alzheimer's InstitutePhoenix, Arizona
- Scottsdale Clinical TrialsScottsdale, Arizona
- Advanced Research Center, Inc.Anaheim, California
- Inland Psychiatric Medical Group (IPMG)-ChinoChino, California