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NCT06126224 · 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-2)
A Phase 3 study of Psychosis Associated With Alzheimer's Disease, sponsored by Karuna Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06126224: Active Phase 3 study of Psychosis Associated With Alzheimer's Disease, sponsored by Karuna Therapeutics.
NCT06126224 is a Phase 3 study of Psychosis Associated With Alzheimer's Disease that is active but no longer recruiting, run by Karuna Therapeutics. The registered enrollment target is 400 participants, below the 463-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06126224, a Phase 3 study of Psychosis Associated With Alzheimer's Disease, is active but no longer recruiting, sponsored by Karuna Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Primary Outcome
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG KarXT
Study Locations (20)
Florida
- Local Institution - 1156 - Clermont
- Local Institution - 1138 - Cutler Bay
- Local Institution - 1162 - Delray Beach
- Local Institution - 1164 - Doral
- Local Institution - 1165 - Fort Myers
- Local Institution - 1155 - Hialeah
- Local Institution - 1107 - Hialeah
- Local Institution - 1120 - Hialeah
- Local Institution - 1140 - Hialeah
- Local Institution - 0150 - Homestead
- Local Institution - 1145 - Homestead
California
- Local Institution - 1104 - Anaheim
- Local Institution - 1119 - Canoga Park
- Local Institution - 1151 - Encino
- Local Institution - 1142 - Lancaster
- Local Institution - 1117 - Los Alamitos
- Local Institution - 1103 - Sherman Oaks
- Local Institution - 1007 - Walnut Creek
Arizona
- Local Institution - 1116 - Chandler
- Local Institution - 1044 - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-08-28 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 3 |
What the registry record for NCT06126224 still lists
NCT06126224 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 463-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (14% 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.
NCT06126224 names 20 study sites across 3 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06126224 about?
NCT06126224 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-2)". This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary ob...
What is the current status of trial NCT06126224?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2023-08-28. Estimated completion is 2025-07-31.
What conditions does trial NCT06126224 study?
This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.
What interventions are being tested in trial NCT06126224?
The interventions under investigation include: Placebo (DRUG), KarXT (DRUG).
Who is sponsoring clinical trial NCT06126224?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06126224 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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