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NCT06651567 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
A Phase 2 study of Agitation Associated With Alzheimer's Dementia, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 20
- Study locations
NCT06651567: Recruiting Phase 2 study of Agitation Associated With Alzheimer's Dementia, sponsored by Intra-Cellular Therapies.
NCT06651567 is a Phase 2 study of Agitation Associated With Alzheimer's Dementia that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 320 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06651567, a Phase 2 study of Agitation Associated With Alzheimer's Dementia, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia
Primary Outcome
The CMAI is a reliable and validated, 29-item caregiver-rating questionnaire to assess agitated behavior in elderly patients. Each item is rated on a 7-point scale of frequency, from "never" (1) to "several times an hour" (7), with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ITI-1284
Study Locations (20)
Florida
- Clinical Site - Boca Raton
- Clinical Site - Bonita Springs
- Clinical Site - Brandon
- Clinical Site - Delray Beach
- Clinical Site - Doral
- Clinical Site - Hialeah
- Clinical Site - Homestead
- Clinical Site_2 - Maitland
- Clinical Site - Maitland
- Clinical Site - Miami
- Clinical Site_2 - Miami
- Clinical Site_3 - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
California
- Clinical Site - Anaheim
- Clinical Site - Costa Mesa
- Clinical Site - Garden Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2024-10-22 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT06651567 shows while recruiting
NCT06651567 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher).
The record links to 1 condition, with Agitation Associated With Alzheimer's Dementia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06651567 names 20 study sites across 2 states, led by Florida, California.
Frequently Asked Questions
What is clinical trial NCT06651567 about?
NCT06651567 is a clinical study titled "A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia". This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia
What is the current status of trial NCT06651567?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2024-10-22. Estimated completion is 2027-11.
What conditions does trial NCT06651567 study?
This clinical trial studies the following conditions: Agitation Associated With Alzheimer's Dementia.
What interventions are being tested in trial NCT06651567?
The interventions under investigation include: Placebo (DRUG), ITI-1284 (DRUG).
Who is sponsoring clinical trial NCT06651567?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06651567 being conducted?
This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06651567's enrollment target sits among peer trials
320 152nd of 2000 higher than 1,848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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