Recruiting

Phase 2

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

Sponsor:

Intra-Cellular Therapies, Inc.

Code:

NCT06651567

Conditions

Agitation Associated With Alzheimer's Dementia

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

ITI-1284

Placebo

Study Details

Brief summary:

This is 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.

Conditions

Agitation Associated With Alzheimer's Dementia

Study ID

NCT06651567

Start date

Oct 22, 2024

Status verified date

Aug, 2026

Completion date

Dec 28, 2027

Anticipated

Primary completion date

Dec 28, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not 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 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 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.

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

placebo comparator: Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Interventions

ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Primary outcome measure

Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Advanced Research Center, Inc

Recruiting

Anaheim, California, United States, 92805

SFM Clinical Research LLC

Recruiting

Boca Raton, Florida, United States, 33487

Envision Trials LLC

Recruiting

Bonita Springs, Florida, United States, 34134

Clinical Research of Brandon

Recruiting

Brandon, Florida, United States, 33511

Science Connections LLC

Recruiting

Doral, Florida, United States, 33178

Direct Helpers Medical Center, Inc.

Recruiting

Hialeah, Florida, United States, 33012-3618

Homestead Associates in Research Inc

Recruiting

Homestead, Florida, United States, 33033

K2 Medical Research

Recruiting

Maitland, Florida, United States, 32751

Neurology Associates PA

Recruiting

Maitland, Florida, United States, 32751

Vital Care Research

Recruiting

Miami, Florida, United States, 33122

Advanced Clinical Research Network

Recruiting

Miami, Florida, United States, 33135

Wellness Research Center

Recruiting

Miami, Florida, United States, 33135

Allied Biomedical Research Institute (ABRI), Inc

Recruiting

Miami, Florida, United States, 33155-4630

South Florida Research Phase I-IV

Recruiting

Miami, Florida, United States, 33166

Sunshine Medical Research Studies Inc

Recruiting

Miami, Florida, United States, 33186

Charter Research

Recruiting

Orlando, Florida, United States, 32803

Psych Me Medical Research Inc

Recruiting

Tampa, Florida, United States, 33614

Quantum Research Associates Corp

Recruiting

Tampa, Florida, United States, 33614

Premiere Research Institute at Palm Beach Neurology

Recruiting

West Palm Beach, Florida, United States, 33407

Tufts University School of Medicine

Recruiting

Boston, Massachusetts, United States, 02111

Oasis Clinical Research LLC

Recruiting

Las Vegas, Nevada, United States, 89121

Bio Behavioral Health

Recruiting

Toms River, New Jersey, United States, 08755

More Information

Sponsor

Intra-Cellular Therapies, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intra-Cellular Therapies, Inc. on 2026-08-26.