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 Agitation Associated With Alzheimer's Disease
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use app…
Interventions
- DrugXanomeline/Trospium Chloride Capsule
Specified dose on specified days
- DrugXanomeline Enteric Capsule
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (157)
- Imaging EndpointsScottsdale, Arizona
- Advanced Research Center (ARC) - AnaheimAnaheim, California
- Kaizen Brain CenterLa Jolla, California
- The Neurology GroupPomona, California
- Torrance Clinical ResearchTorrance, California
- Sunwise Clinical ResearchWalnut Creek, California