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NCT06585787 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
A Phase 3 study of Alzheimer Disease, sponsored by Karuna Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
- 20
- Study locations
NCT06585787: Recruiting Phase 3 study of Alzheimer Disease, sponsored by Karuna Therapeutics.
NCT06585787 is a Phase 3 study of Alzheimer Disease that is actively recruiting participants, run by Karuna Therapeutics. The registered enrollment target is 406 participants, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06585787, a Phase 3 study of Alzheimer Disease, is actively recruiting participants, sponsored by Karuna Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG KarXT
Study Locations (20)
California
- Advanced Research Center, Inc. - Anaheim
- Inland Psychiatric Medical Group (IPMG)-Chino - Chino
- Long Beach Research Institute, LLC - Long Beach
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) - Los Angeles
- Local Institution - 1219 - Los Angeles
- ATP Clinical Research-302 W La Veta Ave - Orange
- NRC Research Institute - Orange - PPDS - Orange
- SC3 Research - Pasadena - 960 E. Green St - Pasadena
- Prospective Research Innovations 8577 Haven Ave - Rancho Cucamonga
Florida
- Genesis Trust Research Group - Atlantis
- Envision Trials LLC - Bonita Springs
- JY Research Institute Inc - Cutler Bay
- Arrow Clinical Trials - Daytona Beach
- Quantum Laboratories, Inc - West Palm Beach Office - Deerfield Beach
- Integrity Clinical Research LLC - 21st Street - Doral
Arizona
- Chandler Clinical Trials, LLC - Chandler
- Gilbert Neurology Partners - PLLC - Avacare - Gilbert
- Banner Alzheimer's Institute - Phoenix
- Scottsdale Clinical Trials - Scottsdale
Connecticut
- University of Connecticut Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2026-10-19 |
| Phase | Phase 3 |
What NCT06585787 shows while recruiting
NCT06585787 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 2,749-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06585787 names 20 study sites across 4 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06585787 about?
NCT06585787 is a clinical study titled "A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)". 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.
What is the current status of trial NCT06585787?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2024-09-26. Estimated completion is 2026-10-19.
What conditions does trial NCT06585787 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT06585787?
The interventions under investigation include: Placebo (DRUG), KarXT (DRUG).
Who is sponsoring clinical trial NCT06585787?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06585787 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06585787's enrollment target sits among peer trials
406 62nd of 306 higher than 244 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
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