RecruitingPhase 2NCT06540833

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease

Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

370 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Psychosis Associated With Alzheimer's Disease

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.

Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called ITI-1284 for treating psychosis (hallucinations, delusions, or agitation) in people living with Alzheimer's disease. Psychosis is a common and distressing symptom in Alzheimer's, and currently available antipsychotic medications have significant side effects in elderly patients. **You may be eligible if...** - You (or your loved one) meet established clinical criteria for Alzheimer's disease - There is evidence of Alzheimer's-related changes in the brain (confirmed by a blood biomarker) - You are experiencing psychosis symptoms such as hallucinations or delusions related to Alzheimer's - A legally authorized representative can provide consent if the patient is unable to do so **You may NOT be eligible if...** - Your psychosis is caused by another condition unrelated to Alzheimer's - You have a history of certain heart rhythm problems - You have severe liver or kidney disease - You are already taking certain medications that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGITI-1284

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

DRUGPlacebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Locations(65)

Advanced Research Center, Inc

Anaheim, California, United States

Pharmacology Research Institute

Los Alamitos, California, United States

Wr Pri Llc

Newport Beach, California, United States

ATP Clinical Research

Orange, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Clinical Research of Brandon

Brandon, Florida, United States

Healthcare Innovations Institute Inc

Coral Springs, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Science Connections LLC

Doral, Florida, United States

Homestead Associates in Research Inc

Homestead, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Wellness Research Center

Miami, Florida, United States

Ocean Blue Medical Research Center Inc.

Miami, Florida, United States

Allied Biomedical Research Institute (ABRI), Inc

Miami, Florida, United States

South Florida Research Phase I-IV

Miami, Florida, United States

Sunshine Medical Solution

Miami, Florida, United States

Combined Research Orlando

Orlando, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

University of South Florida

Tampa, Florida, United States

Psych Me Medical Research Inc

Tampa, Florida, United States

Bio Behavioral Health

Toms River, New Jersey, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

Horizon Clinical Research Group

Cypress, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Medical Center Sv Dimitar Blagoevgrad

Blagoevgrad, Bulgaria

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

Cherven Bryag, 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

Mental Health Center - Vratsa EOOD

Vratsa, Bulgaria

Polyclinic Neuron

Zagreb, Croatia

University Hospital Centre Zagreb 1

Zagreb, Croatia

University Hospital Centre Zagreb

Zagreb, Croatia

Psychiatric Clinic "VRAPCE"

Zagreb, Croatia

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

Neuro Health Centrum s r o

Brno, Czechia

NEUROHK s r o

Hradec Králové, Czechia

INEP medical s.r.o.

Prague, Czechia

Przychodnia Srodmiescie SP. z o.o.

Bydgoszcz, Poland

Neuro Care

Katowice, Poland

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

Ścinawa, Poland

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 Elisabeta Doamna Galaţi

Galati, Romania

SC Carpe Diem SRL

Sibiu, Romania

Clinical Center Dr Dragisa Misovic Dedinje

Belgrade, Serbia

Special Hospital for Psychiatric Diseases Kovin

Kovin, Serbia

University Clinical Center Kragujevac

Kragujevac, 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

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Epamed sro

Košice, Slovakia

NEURES s r o

Krompachy, Slovakia

Crystal Comfort s.r.o.

Vranov nad Topľou, Slovakia

Hosp. Gral. de Albacete

Albacete, Spain

Hosp. Prov. de Zamora

Zamora, Spain

Hosp. Viamed Montecanal

Zaragoza, Spain

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NCT06540833

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