A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia
Public ClinicalTrials.gov record NCT06651567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06651567
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Industry
- Enrollment
- 320 participants
Conditions and interventions
Interventions
- ITI-1284 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2024
- Primary completion
- Sep 30, 2027
- Completion
- Oct 31, 2027
- Last update posted
- Jan 11, 2026
2024 – 2027
United States locations
- U.S. sites
- 30
- U.S. states
- 7
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site | Anaheim | California | 92805 | Recruiting |
| Clinical Site | Costa Mesa | California | 92626 | Recruiting |
| Clinical Site | Garden Grove | California | 92844 | Recruiting |
| Clinical Site | Boca Raton | Florida | 33487 | Recruiting |
| Clinical Site | Bonita Springs | Florida | 34134 | Recruiting |
| Clinical Site | Brandon | Florida | 33511 | Recruiting |
| Clinical Site | Delray Beach | Florida | 33445 | Recruiting |
| Clinical Site | Doral | Florida | 33178 | Recruiting |
| Clinical Site | Hialeah | Florida | 33012 | Recruiting |
| Clinical Site | Homestead | Florida | 33033 | Recruiting |
| Clinical Site_2 | Maitland | Florida | 32751 | Recruiting |
| Clinical Site | Maitland | Florida | 32751 | Recruiting |
| Clinical Site | Miami | Florida | 33122 | Recruiting |
| Clinical Site_2 | Miami | Florida | 33135 | Recruiting |
| Clinical Site_3 | Miami | Florida | 33135 | Recruiting |
| Clinical Site | Miami | Florida | 33135 | Recruiting |
| Clinical Site | Miami | Florida | 33137 | Recruiting |
| Clinical Site | Miami | Florida | 33155 | Recruiting |
| Clinical Site | Miami | Florida | 33166 | Recruiting |
| Clinical Site | Miami | Florida | 33186 | Recruiting |
| Clinical Site | Orlando | Florida | 32803 | Recruiting |
| Clinical Site | Orlando | Florida | 32807 | Recruiting |
| Clinical Site_2 | Tampa | Florida | 33614 | Recruiting |
| Clinical Site | Tampa | Florida | 33614 | Recruiting |
| Clinical Site | West Palm Beach | Florida | 33407 | Recruiting |
| Clinical Site | Boston | Massachusetts | 02111 | Recruiting |
| Clinical Site | Las Vegas | Nevada | 89121 | Recruiting |
| Clinical Site | Toms River | New Jersey | 08755 | Recruiting |
| Clinical Site | Raleigh | North Carolina | 27607 | Recruiting |
| Clinical Site | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06651567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 11, 2026 · Synced May 14, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06651567 live on ClinicalTrials.gov.