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

NCT06540833

This study is recruiting at 18 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Psychotic Disorders
  • Alzheimer Disease

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
55 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Intra-Cellular Therapies, Inc.
Last updated on ClinicalTrials.gov
September 29, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • Advanced Research Center, Inc · Anaheim, CA
  • Sunwise Clinical Research · Walnut Creek, CA

Florida · 9

  • Envision Trials LLC · Bonita Springs, FL
  • Clinical Research of Brandon · Brandon, FL
  • Science Connections LLC · Doral, FL
  • Homestead Associates in Research Inc · Homestead, FL
  • K2 Medical Research · Maitland, FL
  • Allied Biomedical Research Institute (ABRI), Inc · Miami, FL
  • South Florida Research Phase I-IV · Miami, FL
  • Intercoastal Medical Group · Sarasota, FL
  • University of South Florida · Tampa, FL

Georgia · 1

  • CenExeli Research LLC · Savannah, GA

New Jersey · 1

  • Bio Behavioral Health · Toms River, NJ

North Carolina · 2

  • New Hope Clinical Research · Charlotte, NC
  • AMC Research, LLC · Matthews, NC

Texas · 2

  • Horizon Clinical Research Group · Cypress, TX
  • University of Texas Health Science Center at San Antonio · San Antonio, TX

Washington · 1

  • Northwest Clinical Research Center · Bellevue, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.