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

NCT06651567 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ITI-1284-101
• Study Type: interventional
• Target: 320
• Locations: 8 countries
• Sites: 70

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

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI) total score

  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.

  Week 12

Secondary Outcomes (1)

• Clinical Global Impression-Severity (CGI-S) Score

  Week 12

Study Arms (2)

ITI-1284

EXPERIMENTAL

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

Drug: ITI-1284

Placebo

PLACEBO COMPARATOR

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

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 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (70)

Advanced Research Center, Inc

Anaheim, California, 92805, United States

RECRUITING

ATP Clinical Research

Costa Mesa, California, 92626, United States

RECRUITING

National Institute Of Clinical Research

Garden Grove, California, 92844, United States

COMPLETED

Wr Pri Llc

Newport Beach, California, 92660, United States

COMPLETED

SFM Clinical Research LLC

Boca Raton, Florida, 33487, United States

RECRUITING

Envision Trials LLC

Bonita Springs, Florida, 34134, United States

RECRUITING

Clinical Research of Brandon

Brandon, Florida, 33511, United States

RECRUITING

Brain Matters Research

Delray Beach, Florida, 33445, United States

COMPLETED

Science Connections LLC

Doral, Florida, 33178, United States

RECRUITING

Direct Helpers Medical Center, Inc.

Hialeah, Florida, 33012-3618, United States

RECRUITING

Homestead Associates in Research Inc

Homestead, Florida, 33033, United States

RECRUITING

K2 Medical Research

Maitland, Florida, 32751, United States

RECRUITING

Neurology Associates PA

Maitland, Florida, 32751, United States

RECRUITING

Vital Care Research

Miami, Florida, 33122, United States

RECRUITING

Advance Medical Research Center

Miami, Florida, 33135, United States

SUSPENDED

Advanced Clinical Research Network

Miami, Florida, 33135, United States

RECRUITING

Wellness Research Center

Miami, Florida, 33135, United States

RECRUITING

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

Miami Jewish Health System

Miami, Florida, 33180, United States

RECRUITING

Sunshine Medical Research Studies Inc

Miami, Florida, 33186, United States

RECRUITING

Charter Research

Orlando, Florida, 32803, United States

RECRUITING

Combined Research Orlando

Orlando, Florida, 32807, United States

COMPLETED

Psych Me Medical Research Inc

Tampa, Florida, 33614, United States

RECRUITING

Quantum Research Associates Corp

Tampa, Florida, 33614, United States

RECRUITING

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

RECRUITING

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

Oasis Clinical Research LLC

Las Vegas, Nevada, 89121, United States

RECRUITING

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

RECRUITING

Eximia Clinical Research NC

Raleigh, North Carolina, 27607, United States

COMPLETED

UT Health San Antonio

San Antonio, Texas, 78229, United States

SUSPENDED

State Psychiatric Hospital - Lovech

Lovech, 5500, Bulgaria

RECRUITING

Medical Center Medconsult-Pleven

Pleven, 5800, 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

University Hospital Centre Zagreb 1

Zagreb, 10000, Croatia

COMPLETED

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

Psychiatric Clinic "VRAPCE"

Zagreb, 10090, Croatia

RECRUITING

Psychiatric Hospital Sveti Ivan

Zagreb, 10090, Croatia

RECRUITING

Fakultni nemocnice u sv. Anny v Brne

Brno, 602 00, Czechia

RECRUITING

NEUROHK s r o

Choceň, 56501, Czechia

RECRUITING

Neuroterapie KH S R O

Kutná Hora, 284 01, Czechia

RECRUITING

A Shine S R O

Pilsen, 301 00, Czechia

RECRUITING

Clintrial s r o

Prague, 100 00, Czechia

RECRUITING

NeuropsychiatrieHK, s.r.o.

Prague, 160 00, Czechia

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

RECRUITING

Spitalul de Psihiatrie si Neurologie Brasov

Com Sanpetru, 507190, Romania

RECRUITING

SC Carpe Diem SRL

Sibiu, 550281, Romania

RECRUITING

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Institute of Mental Health Serbia

Belgrade, 11000, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Kovin

Kovin, 26220, Serbia

COMPLETED

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

RECRUITING

Univerzitna nemocnica Bratislava

Bratislava, 81369, Slovakia

RECRUITING

Epamed sro

Košice, 4001, Slovakia

RECRUITING

NEURES s r o

Krompachy, 05342, Slovakia

RECRUITING

Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.

Svidník, 089 01, Slovakia

RECRUITING

Crystal Comfort s.r.o.

Vranov nad Topľou, 09301, Slovakia

RECRUITING

Hosp. Gral. de Albacete

Albacete, 02006, Spain

RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

RECRUITING

Hosp. Quirónsalud Málaga

Málaga, 29004, Spain

RECRUITING

Hosp. Prov. de Zamora

Zamora, 49021, Spain

RECRUITING

Hosp. Viamed Montecanal

Zaragoza, 50012, Spain

RECRUITING

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: October 18, 2024
• First Posted: October 21, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (7); RO (6); SL (6); CZ (6); US (31); SE (5); CR (4); ES (5)