A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Eligibility
- Age range
- 60–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach. * Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening. * Participants must have a designated caregiver wh…
Interventions
- DrugKarXT
Specified dose on specified days
- DrugKarX-EC
Specified dose on specified days
- OtherPlacebo
Specified dose on specified days
Locations (106)
- Healthy Brain ClinicLong Beach, California
- Anderson Clinical ResearchRedlands, California
- Mountain Neurological Research CenterBasalt, Colorado
- Georgetown University Medical CenterWashington D.C., District of Columbia
- JEM Research InstituteAtlantis, Florida
- VIN-Julie SchwartzbardAventura, Florida