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RECRUITING

NCT06651567

PHASE2

A 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.

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2024-10-22

Completion Date

2027-12-28

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Agitation Associated With Alzheimer's Dementia

Interventions

DRUG

ITI-1284

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

DRUG

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

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.

Locations (70)

Advanced Research Center, Inc

Anaheim, California, United States

ATP Clinical Research

Costa Mesa, California, United States

National Institute Of Clinical Research

Garden Grove, California, United States

Wr Pri Llc

Newport Beach, California, United States

SFM Clinical Research

Boca Raton, Florida, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Clinical Research of Brandon

Brandon, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Science Connections LLC

Doral, Florida, United States

Direct Helpers Medical Center, Inc.

Hialeah, Florida, United States

Homestead Associates in Research Inc

Homestead, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Vital Care Research

Miami, Florida, United States

Advance Medical Research Center

Miami, Florida, United States

Advanced Clinical Research Network

Miami, Florida, United States

Wellness Research Center

Miami, Florida, United States

Allied Biomedical Research Institute (ABRI), Inc

Miami, Florida, United States

South Florida Research Phase I-IV

Miami, Florida, United States

Miami Jewish Health System

Miami, Florida, United States

Sunshine Medical Research Studies Inc

Miami, Florida, United States

Charter Research

Orlando, Florida, United States

Combined Research Orlando

Orlando, Florida, United States

Psych Me Medical Research Inc

Tampa, Florida, United States

Quantum Research Associates Corp

Tampa, Florida, United States

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Tufts University School of Medicine

Boston, Massachusetts, United States

Oasis Clinical Research LLC

Las Vegas, Nevada, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Eximia Clinical Research NC

Raleigh, North Carolina, United States

UT Health San Antonio

San Antonio, Texas, United States

State Psychiatric Hospital - Lovech

Lovech, Bulgaria

Medical Center Medconsult-Pleven

Pleven, Bulgaria

Mental Health Centre Prof. N Shipkovenski EOOD

Sofia, Bulgaria

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

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica, OOD

Sofia, Bulgaria

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, Bulgaria

University Hospital Centre Zagreb 1

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Psychiatric Clinic "VRAPCE"

Zagreb, Croatia

Psychiatric Hospital Sveti Ivan

Zagreb, Croatia

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

NEUROHK s r o

Choceň, Czechia

Neuroterapie KH S R O

Kutná Hora, Czechia

A Shine S R O

Pilsen, Czechia

Clintrial s r o

Prague, Czechia

NeuropsychiatrieHK, s.r.o.

Prague, Czechia

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

Bucharest, Romania

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia 1

Bucharest, Romania

Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia

Bucharest, Romania

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

Bucharest, Romania

Spitalul de Psihiatrie si Neurologie Brasov

Com Sanpetru, Romania

SC Carpe Diem SRL

Sibiu, Romania

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, Serbia

Institute of Mental Health Serbia

Belgrade, Serbia

Special Hospital for Psychiatric Diseases Kovin

Kovin, Serbia

University Clinical Center NIS

Niš, Serbia

Special Hospital for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, Serbia

Neurologicka ambulancia MUDr.Dupejova s.r.o.

Banská Bystrica, Slovakia

Univerzitna nemocnica Bratislava

Bratislava, Slovakia

Epamed sro

Košice, Slovakia

NEURES s r o

Krompachy, Slovakia

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

Svidník, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Hosp. Gral. de Albacete

Albacete, Spain

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Hosp. Quirónsalud Málaga

Málaga, Spain

Hosp. Prov. de Zamora

Zamora, Spain

Hosp. Viamed Montecanal

Zaragoza, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)