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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 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. The trial reports 20 study locations across 2 states.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06651567
The ClinicalTrials.gov registry entry for NCT06651567 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Related
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