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Evaluating ITI-1284 for treating psychosis in Alzheimer's patients

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

PHASE2 · Intra-Cellular Therapies, Inc. · NCT06540833

This study is testing a new medication called ITI-1284 to see if it can help reduce psychotic symptoms in people with Alzheimer's disease.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment370 (estimated)
Ages55 Years and up
SexAll
SponsorIntra-Cellular Therapies, Inc. (industry)
Locations65 sites (Anaheim, California and 64 other locations)
Trial IDNCT06540833 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, parallel-group, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients experiencing psychosis associated with Alzheimer's Disease. The trial consists of a screening period to determine eligibility, a 6-week double-blind treatment phase where participants receive either ITI-1284 or a placebo, and a 30-day safety follow-up period. The study will evaluate how well ITI-1284 works compared to placebo in alleviating psychotic symptoms in this patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Alzheimer's Disease who exhibit symptoms of psychosis and meet specific eligibility criteria.

Not a fit: Patients without a confirmed diagnosis of Alzheimer's Disease or those not experiencing psychosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of psychosis in Alzheimer's patients, enhancing their quality of life.

How similar studies have performed: Previous studies have explored treatments for psychosis in Alzheimer's, but the specific approach with ITI-1284 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \[LAR\]) before the initiation of any study-specific procedures in accordance with local regulations;
2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:

   1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
   2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
4. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline;
5. CGI-S score ≥ 4 at Screening and Baseline;
6. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures;
7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

Exclusion Criteria:

1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (eg, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:

   1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
   2. Bipolar disorder;
2. Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening;
3. The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee,
4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
5. The patient is bedridden or has any significant medical condition that is unstable and would either:

   1. Place the patient at undue risk from study drug or undergoing study procedures; or
   2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
6. The patient is in hospice or end-of-life care;

Where this trial is running

Anaheim, California and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Psychosis Associated With Alzheimer's Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.