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

NCT06540833 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ITI-1284-201
• Study Type: interventional
• Target: 370
• Locations: 9 countries
• Sites: 65

Brief Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.

Conditions

Psychosis Associated With Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• BEHAVE-AD psychosis subscale score

  The BEHAVE-AD psychosis subscale is comprised of 7 items from the paranoid and delusional ideations domain and 5 items from the hallucinations domain. The scale is rated on a 4--point scale of severity, from 0 (not present) to 3 (present, generally with an emotional and physical component). The maximum score for the psychosis subscale is 36.

  Week 6

Secondary Outcomes (1)

• CGI-S score

  Week 6

Study Arms (2)

ITI-1284

EXPERIMENTAL

Drug: ITI-1284

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ITI-1284 DRUG

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

ITI-1284

Placebo DRUG

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 AD based on 2011 NIA-AA criteria and either:
• Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening; or
• Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;
• Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline;
• 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;
• CGI-S score ≥ 4 at Screening and Baseline;
• 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;
• Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver);

You may not qualify if:

• 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:
• Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;
• Bipolar disorder;
• 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;
• 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,
• The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia
• The patient is bedridden or has any significant medical condition that is unstable and would either:
• Place the patient at undue risk from study drug or undergoing study procedures; or
• Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study;
• The patient is in hospice or end-of-life care;

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (65)

Advanced Research Center, Inc

Anaheim, California, 92805, United States

RECRUITING

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

TERMINATED

Wr Pri Llc

Newport Beach, California, 92660, United States

COMPLETED

ATP Clinical Research

Orange, California, 92866, United States

COMPLETED

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

RECRUITING

Envision Trials LLC

Bonita Springs, Florida, 34134, United States

RECRUITING

Clinical Research of Brandon

Brandon, Florida, 33511, United States

SUSPENDED

Healthcare Innovations Institute Inc

Coral Springs, Florida, 33067, United States

COMPLETED

Brain Matters Research

Delray Beach, Florida, 33445, United States

COMPLETED

Science Connections LLC

Doral, Florida, 33178, United States

RECRUITING

Homestead Associates in Research Inc

Homestead, Florida, 33033, United States

RECRUITING

K2 Medical Research

Maitland, Florida, 32751, United States

RECRUITING

Wellness Research Center

Miami, Florida, 33135, United States

RECRUITING

Ocean Blue Medical Research Center Inc.

Miami, Florida, 33144, United States

SUSPENDED

Allied Biomedical Research Institute (ABRI), Inc

Miami, Florida, 33155-4630, United States

RECRUITING

South Florida Research Phase I-IV

Miami, Florida, 33166, United States

RECRUITING

Sunshine Medical Solution

Miami, Florida, 33186, United States

RECRUITING

Combined Research Orlando

Orlando, Florida, 32803, United States

COMPLETED

Intercoastal Medical Group

Sarasota, Florida, 34239, United States

RECRUITING

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Psych Me Medical Research Inc

Tampa, Florida, 33614, United States

SUSPENDED

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

RECRUITING

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

RECRUITING

Horizon Clinical Research Group

Cypress, Texas, 77065, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, 2700, Bulgaria

RECRUITING

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry Dr. Ivo Natsov ET

Cherven Bryag, 5980, Bulgaria

RECRUITING

Mental Health Centre Prof. N Shipkovenski EOOD

Sofia, 1377, Bulgaria

RECRUITING

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

Sofia, 1408, Bulgaria

RECRUITING

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

RECRUITING

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, 6003, Bulgaria

RECRUITING

Mental Health Center - Vratsa EOOD

Vratsa, 3000, Bulgaria

COMPLETED

Polyclinic Neuron

Zagreb, 10000, Croatia

RECRUITING

University Hospital Centre Zagreb 1

Zagreb, 10000, Croatia

COMPLETED

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

SUSPENDED

Psychiatric Clinic "VRAPCE"

Zagreb, 10090, Croatia

RECRUITING

Fakultni nemocnice u sv. Anny v Brne

Brno, 60200, Czechia

RECRUITING

Neuro Health Centrum s r o

Brno, 62800, Czechia

RECRUITING

NEUROHK s r o

Hradec Králové, 50002, Czechia

RECRUITING

INEP medical s.r.o.

Prague, 18600, Czechia

COMPLETED

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, 85 080, Poland

COMPLETED

Neuro Care

Katowice, 40-749, Poland

COMPLETED

Osrodek Badawczo Naukowo Dydaktyczny Chorob Otepiennych UM im Piastow Slaskich we Wroclawiu

Ścinawa, 59-330, Poland

RECRUITING

Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

Bucharest, 010825, Romania

RECRUITING

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1

Bucharest, 040874, Romania

RECRUITING

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, 041914, Romania

RECRUITING

Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian

Bucharest, 60222, Romania

SUSPENDED

Spitalul De Psihiatrie Elisabeta Doamna Galaţi

Galati, 800179, Romania

RECRUITING

SC Carpe Diem SRL

Sibiu, 550281, Romania

RECRUITING

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Kovin

Kovin, 26220, Serbia

COMPLETED

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center NIS

Niš, 18000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, 23330, Serbia

RECRUITING

Neurologicka ambulancia MUDr.Dupejova s.r.o.

Banská Bystrica, 97404, Slovakia

COMPLETED

Univerzitna nemocnica Bratislava

Bratislava, 81369, Slovakia

RECRUITING

Univerzitna nemocnica L. Pasteura Kosice

Košice, 04190, Slovakia

RECRUITING

Epamed sro

Košice, 4001, Slovakia

RECRUITING

NEURES s r o

Krompachy, 05342, Slovakia

RECRUITING

Crystal Comfort s.r.o.

Vranov nad Topľou, 09301, Slovakia

RECRUITING

Hosp. Gral. de Albacete

Albacete, 02006, Spain

RECRUITING

Hosp. Prov. de Zamora

Zamora, 49021, Spain

RECRUITING

Hosp. Viamed Montecanal

Zaragoza, 50012, Spain

SUSPENDED

Study Officials

• Intra-Cellular Therapies, Inc. Clinical Trial

  Intra-Cellular Therapies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); SL (6); SE (5); RO (6); BU (8); ES (3); PL (3); CZ (4); CR (4)