Trials / Recruiting
RecruitingNCT07011745
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-2)
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
- 2025-07-16
- Primary completion
- 2028-11-03
- Completion
- 2028-11-13
- First posted
- 2025-06-10
- Last updated
- 2026-04-01
Locations
140 sites across 14 countries: United States, Argentina, Chile, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Puerto Rico, South Korea, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07011745. Inclusion in this directory is not an endorsement.