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

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

Phase 2 Interventional Intra-Cellular Therapies, Inc. · NCT06651567

This study tests whether a new medication called ITI-1284 can help reduce agitation in people with Alzheimer's disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment320 (estimated)
Ages55 Years and up
SexAll
SponsorIntra-Cellular Therapies, Inc. Industry-sponsored
Locations69 sites (Anaheim, California and 68 other locations)
Trial IDNCT06651567 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy, safety, and tolerability of ITI-1284 in patients experiencing agitation associated with Alzheimer's dementia. The trial consists of three periods: a screening phase lasting up to four weeks, a 12-week double-blind treatment phase where participants receive either ITI-1284 or a placebo, and a 30-day safety follow-up period after treatment. The study will evaluate how well ITI-1284 alleviates agitation symptoms compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease who exhibit agitation and meet specific biomarker criteria.

Not a fit: Patients without a confirmed diagnosis of Alzheimer's disease or those who do not exhibit agitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce agitation symptoms in Alzheimer's patients, improving their quality of life.

How similar studies have performed: Other studies have explored treatments for agitation in Alzheimer's patients, but the specific approach with ITI-1284 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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;
* Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:

  * Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening; or
  * Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition
* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;
* CGI-S score ≥ 4 at Screening and Baseline;
* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;

Exclusion Criteria:

* Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;
* Has been diagnosed with one or more of the following psychiatric conditions:

  * Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
  * Bipolar disorder;
  * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;
* Has a significant 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 Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;
* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.

Where this trial is running

Anaheim, California and 68 other locations

+19 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 → Find more trials like this →
Conditions Agitation Associated With Alzheimer's Dementia
Last reviewed 2026-06-13 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.