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NCT05511363 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
A Phase 3 study of Psychosis Associated With Alzheimer's Disease, sponsored by Karuna Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT05511363: Recruiting Phase 3 study of Psychosis Associated With Alzheimer's Disease, sponsored by Karuna Therapeutics.
NCT05511363 is a Phase 3 study of Psychosis Associated With Alzheimer's Disease that is actively recruiting participants, run by Karuna Therapeutics. The registered enrollment target is 380 participants, below the 468-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05511363, a Phase 3 study of Psychosis Associated With Alzheimer's Disease, is actively recruiting participants, sponsored by Karuna Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG KarXT
Study Locations (20)
Florida
- Local Institution - 1011 - Boca Raton
- Envision Trials LLC - Bonita Springs
- Local Institution - 1015 - Bradenton
- K2 Medical Research - Winter Garden - Clermont
- Arrow Clinical Trials - Daytona Beach
- Local Institution - 1045 - Doral
- Local Institution - 1046 - Hialeah
- Local Institution - 1024 - Hialeah
- Local Institution - 1052 - Hialeah
- Local Institution - 1049 - Homestead
California
- Local Institution - 1033 - Encino
- Local Institution - 1031 - Irvine
- ATP Clinical Research-302 W La Veta Ave - Orange
- Local Institution - 1043 - Pasadena
- Local Institution - 1047 - San Marcos
- Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS - Walnut Creek
Alabama
- Local Institution - 1029 - Homewood
Arizona
- Local Institution - 1044 - Phoenix
Colorado
- Local Institution - 1014 - Colorado Springs
Connecticut
- Local Institution - 1013 - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2022-08-23 |
| Est. Completion | 2026-10-05 |
| Phase | Phase 3 |
What NCT05511363 shows while recruiting
NCT05511363 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, below the 468-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Psychosis Associated With Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05511363 names 20 study sites across 6 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05511363 about?
NCT05511363 is a clinical study titled "A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)". This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease...
What is the current status of trial NCT05511363?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2022-08-23. Estimated completion is 2026-10-05.
What conditions does trial NCT05511363 study?
This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.
What interventions are being tested in trial NCT05511363?
The interventions under investigation include: Placebo (DRUG), KarXT (DRUG).
Who is sponsoring clinical trial NCT05511363?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05511363 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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