A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease
Public ClinicalTrials.gov record NCT06540833. 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 to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06540833
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 370 participants
Conditions and interventions
Conditions
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
- Aug 14, 2024
- Primary completion
- Sep 29, 2028
- Completion
- Dec 28, 2028
- Last update posted
- Aug 30, 2026
2024 – 2028
United States locations
- U.S. sites
- 27
- U.S. states
- 7
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center, Inc | Anaheim | California | 92805 | Recruiting |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | Completed |
| Wr Pri Llc | Newport Beach | California | 92660 | Completed |
| ATP Clinical Research | Orange | California | 92866 | Completed |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | Recruiting |
| Envision Trials LLC | Bonita Springs | Florida | 34134 | Recruiting |
| Clinical Research of Brandon | Brandon | Florida | 33511 | Recruiting |
| Healthcare Innovations Institute Inc | Coral Springs | Florida | 33067 | Completed |
| Brain Matters Research | Delray Beach | Florida | 33445 | Completed |
| Science Connections LLC | Doral | Florida | 33178 | Recruiting |
| Homestead Associates in Research Inc | Homestead | Florida | 33033 | Recruiting |
| K2 Medical Research | Maitland | Florida | 32751 | Recruiting |
| Wellness Research Center | Miami | Florida | 33135 | Suspended |
| Ocean Blue Medical Research Center Inc. | Miami | Florida | 33144 | Suspended |
| Allied Biomedical Research Institute (ABRI), Inc | Miami | Florida | 33155-4630 | Recruiting |
| South Florida Research Phase I-IV | Miami | Florida | 33166 | Recruiting |
| Sunshine Medical Solution | Miami | Florida | 33186 | Suspended |
| Combined Research Orlando | Orlando | Florida | 32803 | Completed |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | Recruiting |
| University of South Florida | Tampa | Florida | 33613 | Recruiting |
| Psych Me Medical Research Inc | Tampa | Florida | 33614 | Completed |
| CenExeli Research LLC | Savannah | Georgia | 31405 | Recruiting |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | Recruiting |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | Recruiting |
| Horizon Clinical Research Group | Cypress | Texas | 77065 | Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | Recruiting |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | 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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06540833, 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 30, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06540833 live on ClinicalTrials.gov.