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A Study of ITI-1284 for Agitation in Alzheimer's Dementia

This study is testing a medication called ITI-1284 to see if it can help reduce agitation (restlessness or distress) in people with Alzheimer's dementia. Participants will receive either ITI-1284 (10 mg or 20 mg rapidly dissolving tablet, taken once daily under the tongue) or a placebo (an inactive substance that looks like the study drug). Researchers will measure changes in agitation using a tool called the Cohen-Mansfield Agitation Inventory (CMAI) after 12 weeks. The study is looking for people aged 55 and older who have agitation associated with Alzheimer's dementia and can provide informed consent, or have a legally authorized person provide it for them. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the study drug or placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 320 participants.
What's involved
You would participate in a screening period of up to 4 weeks, followed by a 12-week treatment period. There will also be a safety follow-up visit about 30 days after your last dose of the study drug.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit approximately 30 days after their last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06651567

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

Recruiting
PHASE2Ages 55+InterventionalTreatment
Intra-Cellular Therapies, Inc.
~320 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:ITI-1284Placebo

At a glance

Recruiting sites
56 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohen-Mansfield Agitation Inventory (CMAI) total score
Measured over Week 12

Conditions

Agitation Associated With Alzheimer's Dementia

Explore related trials

Alzheimer's DiseaseAmyloid

Where it's being run

70 sites across 14 states
Florida22
Bulgaria7
Czechia6
Romania6
Slovakia6
Serbia5
Spain5
California4

Study leadership

  • Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 as detected by an appropriately validated test; 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

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.

What this trial measures

  • Cohen-Mansfield Agitation Inventory (CMAI) total scoreWeek 12

    The CMAI is a reliable and validated, 29-item caregiver-rating questionnaire to assess agitated behavior in elderly patients. Each item is rated on a 7-point scale of frequency, from "never" (1) to "several times an hour" (7), with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203.