Trials / Recruiting
RecruitingNCT07011732
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xanomeline/Trospium Chloride Capsule | Specified dose on specified days |
| DRUG | Xanomeline Enteric Capsule | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-07-10
- Primary completion
- 2028-11-24
- Completion
- 2028-12-08
- First posted
- 2025-06-10
- Last updated
- 2026-04-01
Locations
157 sites across 15 countries: United States, Argentina, Brazil, Bulgaria, Canada, China, Croatia, Greece, India, Japan, Mexico, Portugal, Romania, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07011732. Inclusion in this directory is not an endorsement.