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)

Clinical Site

Anaheim, California, United States

Clinical Site

Costa Mesa, California, United States

Clinical Site

Lafayette, California, United States

Clinical Site

Los Alamitos, California, United States

Clinical Site

Newport Beach, California, United States

Clinical Site

Orange, California, United States

Clinical Site

Bonita Springs, Florida, United States

Clinical Site

Brandon, Florida, United States

Clinical Site

Coral Springs, Florida, United States

Clinical Site

Delray Beach, Florida, United States

Clinical Site

Doral, Florida, United States

Clinical Site

Homestead, Florida, United States

Clinical Site

Maitland, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Sarasota, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

Toms River, New Jersey, United States

Clinical Site

Charlotte, North Carolina, United States

Clinical Site

Cypress, Texas, United States

Clinical Site

San Antonio, Texas, United States

Clinical Site

Bellevue, Washington, United States

Clinical Site

Blagoevgrad, Bulgaria

Clinical Site

Cherven Bryag, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Stara Zagora, Bulgaria

Clinical Site

Vratsa, Bulgaria

Clinical Site_2

Zagreb, Croatia

Clinical Site

Zagreb, Croatia

Clinical Site

Zagreb, Croatia

Clinical Site

Brno, Czechia

Clinical Site

Brno, Czechia

Clinical Site

Hradec Králové, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Bydgoszcz, Poland

Clinical Site

Ścinawa, Poland

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Galati, Romania

Clinical Site

Sibiu, Romania

Clinical Site

Belgrade, Serbia

Clinical Site

Kovin, Serbia

Clinical Site

Kragujevac, Serbia

Clinical Site

Niš, Serbia

Clinical Site

Novi Kneževac, Serbia

Clinical Site

Banská Bystrica, Slovakia

Clinical Site

Bratislava, Slovakia

Clinical Site

Košice, Slovakia

Clinical Site

Košice, Slovakia

Clinical Site

Krompachy, Slovakia

Clinical Site

Vranov nad Topľou, Slovakia

Clinical Site

Albacete, Spain

Clinical Site

Madrid, Spain

Clinical Site

Zamora, Spain

Clinical Site

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06540833

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