RecruitingPhase 2NCT06651567

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

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


Sponsor

Intra-Cellular Therapies, Inc.

Enrollment

320 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ITI-1284 for treating agitation in people with Alzheimer's disease. Agitation — which includes restlessness, irritability, and aggression — is one of the most distressing symptoms of Alzheimer's for both patients and caregivers, and current treatment options are limited. **You may be eligible if...** - You (or your family member or legal representative) can understand and sign informed consent - You meet standard criteria for an Alzheimer's disease diagnosis - You have significant agitation symptoms **You may NOT be eligible if...** - You have a different type of dementia not meeting Alzheimer's criteria - You have serious medical conditions that would make the study drug unsafe - You are pregnant or breastfeeding 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(69)

Clinical Site

Anaheim, California, United States

Clinical Site

Costa Mesa, California, United States

Clinical Site

Garden Grove, California, United States

Clinical Site

Boca Raton, Florida, United States

Clinical Site

Bonita Springs, Florida, United States

Clinical Site

Brandon, Florida, United States

Clinical Site

Delray Beach, Florida, United States

Clinical Site

Doral, Florida, United States

Clinical Site

Hialeah, Florida, United States

Clinical Site

Homestead, Florida, United States

Clinical Site_2

Maitland, Florida, United States

Clinical Site

Maitland, Florida, United States

Clinical Site

Miami, Florida, United States

Clinical Site_2

Miami, Florida, United States

Clinical Site_3

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

Miami, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site

Orlando, Florida, United States

Clinical Site_2

Tampa, Florida, United States

Clinical Site

Tampa, Florida, United States

Clinical Site

West Palm Beach, Florida, United States

Clinical Site

Boston, Massachusetts, United States

Clinical Site

Las Vegas, Nevada, United States

Clinical Site

Toms River, New Jersey, United States

Clinical Site

Raleigh, North Carolina, United States

Clinical Site

San Antonio, Texas, United States

Clinical Site

Lovech, Bulgaria

Clinical Site

Pleven, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Sofia, Bulgaria

Clinical Site

Stara Zagora, Bulgaria

Clinical Site_2

Zagreb, Croatia

Clinical Site_3

Zagreb, Croatia

Clinical Site

Zagreb, Croatia

Clinical Site

Zagreb, Croatia

Clinical Site

Brno, Czechia

Clinical Site

Choceň, Czechia

Clinical Site

Kutná Hora, Czechia

Clinical Site

Pilsen, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Prague, Czechia

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Bucharest, Romania

Clinical Site

Sânpetru, Romania

Clinical Site

Sibiu, Romania

Clinical Site_2

Belgrade, Serbia

Clinical Site

Belgrade, Serbia

Clinical Site

Kovin, 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

Krompachy, Slovakia

Clinical Site

Svidník, Slovakia

Clinical Site

Vranov nad Topľou, Slovakia

Clinical Site

Albacete, Spain

Clinical Site

Barcelona, Spain

Clinical Site

Málaga, Spain

Clinical Site

Zamora, Spain

Clinical Site

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06651567