Trials / Not Yet Recruiting
Not Yet RecruitingNCT06947941
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
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 Psychosis Associated With Alzheimer's Disease
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,046 (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 KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| DRUG | KarX-EC | Specified dose on specified days |
| DRUG | KarXT + KarX-EC Arm Matching Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-07-31
- Primary completion
- 2027-09-27
- Completion
- 2027-10-25
- First posted
- 2025-04-27
- Last updated
- 2025-04-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06947941. Inclusion in this directory is not an endorsement.