RecruitingPhase 2

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

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

Lead sponsor

Intra-Cellular Therapies, Inc.

Asset

ITI-1284

Listed sites

Recruiting sites

Enrollment

320

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (plasma)

Primary endpoint

•Cohen-Mansfield Agitation Inventory (CMAI) total score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDITI-1284-101

NCT IDNCT06651567

Timeline

Milestones

Study first posted2024-10-21actual

Study start2024-10-22actual

Last update posted2026-07-06actual

Primary completion2027-12-28estimated

Study completion2027-12-28estimated

Assets

Drug assets

ITI-1284

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other clinical outcomes

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Cohen-Mansfield Agitation Inventory (CMAI) total score

Time frame:Week 12

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Clinical Global Impression-Severity (CGI-S) Score

Time frame:Week 12

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.