Trials / Recruiting
RecruitingNCT06585787
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 406 (estimated)
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Industry
- Sex
- All
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2024-09-26
- Primary completion
- 2026-09-21
- Completion
- 2026-10-19
- First posted
- 2024-09-19
- Last updated
- 2026-04-01
Locations
281 sites across 25 countries: United States, Argentina, Belgium, Brazil, Bulgaria, China, Croatia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06585787. Inclusion in this directory is not an endorsement.