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NCT06540833 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
A Phase 2 study of Psychosis Associated With Alzheimer's Disease, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 370
- Enrollment target
- 20
- Study locations
NCT06540833: Recruiting Phase 2 study of Psychosis Associated With Alzheimer's Disease, sponsored by Intra-Cellular Therapies.
NCT06540833 is a Phase 2 study of Psychosis Associated With Alzheimer's Disease that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 370 participants, below the 470-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06540833, a Phase 2 study of Psychosis Associated With Alzheimer's Disease, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 370 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.
Primary Outcome
The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ITI-1284
Study Locations (20)
Florida
- Clinical Site - Bonita Springs
- Clinical Site - Brandon
- Clinical Site - Coral Springs
- Clinical Site - Delray Beach
- Clinical Site - Doral
- Clinical Site - Homestead
- Clinical Site - Maitland
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Orlando
- Clinical Site - Sarasota
California
- Clinical Site - Anaheim
- Clinical Site - Costa Mesa
- Clinical Site - Lafayette
- Clinical Site - Los Alamitos
- Clinical Site - Newport Beach
- Clinical Site - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2024-08-15 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
What NCT06540833 shows while recruiting
NCT06540833 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, below the 470-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (21% 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.
NCT06540833 names 20 study sites across 2 states, led by Florida, California.
Frequently Asked Questions
What is clinical trial NCT06540833 about?
NCT06540833 is a clinical study titled "A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease". This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.
What is the current status of trial NCT06540833?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 370 participants. The study started on 2024-08-15. Estimated completion is 2027-10.
What conditions does trial NCT06540833 study?
This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.
What interventions are being tested in trial NCT06540833?
The interventions under investigation include: Placebo (DRUG), ITI-1284 (DRUG).
Who is sponsoring clinical trial NCT06540833?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06540833 being conducted?
This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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