Phase 2 Alzheimer's Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are able to understand what the trial involves and can give signed consent, or whose legal representative can give consent on their behalf if they are not able to do so themselves.
- People who have been diagnosed with Alzheimer's disease based on recognised medical criteria, and who have either a blood test result suggesting Alzheimer's-related brain changes, or past records of a spinal fluid test or a special brain scan confirming this.
- People whose agitation meets the definition set out by an international group of experts in older adult mental health (the IPA).
- People whose agitation is severe enough to score 4 or higher on a standard agitation rating scale (called the NPI-AA) at both an initial screening visit and a baseline visit.
- People who score 4 or higher on a clinical severity rating scale (called the CGI-S) at both the screening and baseline visits.
- People who score between 6 and 24 on a standard memory and thinking assessment (called the MMSE-2) at the screening visit.
Who may not be able to join:
- People whose agitation appears to be caused by other medications, difficult environmental conditions, substance use, or another active medical or mental health condition, based on the doctor's judgment.
- People who have been diagnosed with schizophrenia, schizoaffective disorder, another psychotic condition unrelated to Alzheimer's disease, bipolar disorder, or major depression that has not been stable and treated for at least 8 weeks before the screening visit.
- People considered to be at significant risk of suicidal behaviour during the trial, those seen as an immediate danger to themselves or others, or those who have made one or more suicide attempts in the two years before the screening visit.
- People with a known allergy or sensitivity to the study drug (ITI-1284 or lumateperone) or any of its ingredients.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Phone: 844-434-4210
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Cohen-Mansfield Agitation Inventory (CMAI) total score
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.