Trials / Recruiting
RecruitingNCT06976203
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
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 2)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 586 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| DRUG | KarX-EC | Specified dose on specified days |
| OTHER | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-07-21
- Primary completion
- 2028-09-11
- Completion
- 2029-02-23
- First posted
- 2025-05-16
- Last updated
- 2026-03-31
Locations
123 sites across 17 countries: United States, Argentina, Australia, Brazil, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06976203. Inclusion in this directory is not an endorsement.