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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06651567
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 320 participants
Conditions and interventions
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
- Dec 27, 2027
- Completion
- Dec 27, 2027
- Last update posted
- Aug 25, 2026
2024 – 2027
United States locations
- U.S. sites
- 31
- U.S. states
- 7
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center, Inc | Anaheim | California | 92805 | Recruiting |
| ATP Clinical Research | Costa Mesa | California | 92626 | Completed |
| National Institute Of Clinical Research | Garden Grove | California | 92844 | Completed |
| Wr Pri Llc | Newport Beach | California | 92660 | Completed |
| SFM Clinical Research LLC | Boca Raton | Florida | 33487 | Recruiting |
| Envision Trials LLC | Bonita Springs | Florida | 34134 | Recruiting |
| Clinical Research of Brandon | Brandon | Florida | 33511 | Recruiting |
| Brain Matters Research | Delray Beach | Florida | 33445 | Completed |
| Science Connections LLC | Doral | Florida | 33178 | Recruiting |
| Direct Helpers Medical Center, Inc. | Hialeah | Florida | 33012-3618 | Recruiting |
| Homestead Associates in Research Inc | Homestead | Florida | 33033 | Recruiting |
| K2 Medical Research | Maitland | Florida | 32751 | Recruiting |
| Neurology Associates PA | Maitland | Florida | 32751 | Recruiting |
| Vital Care Research | Miami | Florida | 33122 | Recruiting |
| Advance Medical Research Center | Miami | Florida | 33135 | Suspended |
| Advanced Clinical Research Network | Miami | Florida | 33135 | Recruiting |
| Wellness Research Center | Miami | Florida | 33135 | Recruiting |
| Allied Biomedical Research Institute (ABRI), Inc | Miami | Florida | 33155-4630 | Recruiting |
| South Florida Research Phase I-IV | Miami | Florida | 33166 | Recruiting |
| Miami Jewish Health System | Miami | Florida | 33180 | Completed |
| Sunshine Medical Research Studies Inc | Miami | Florida | 33186 | Recruiting |
| Charter Research | Orlando | Florida | 32803 | Recruiting |
| Combined Research Orlando | Orlando | Florida | 32807 | Completed |
| Psych Me Medical Research Inc | Tampa | Florida | 33614 | Recruiting |
| Quantum Research Associates Corp | Tampa | Florida | 33614 | Recruiting |
| Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | Recruiting |
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | Recruiting |
| Oasis Clinical Research LLC | Las Vegas | Nevada | 89121 | Recruiting |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | Recruiting |
| Eximia Clinical Research NC | Raleigh | North Carolina | 27607 | Completed |
| UT Health San Antonio | San Antonio | Texas | 78229 | Suspended |
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 Aug 25, 2026 · Synced Sep 7, 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.