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

NCT06651567

This study is recruiting at 23 US sites in 6 states, according to its ClinicalTrials.gov record last updated .

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.

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

Conditions studied

  • Agitation Associated With Alzheimer's Dementia

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 · 1

  • Advanced Research Center, Inc · Anaheim, CA

Florida · 18

  • SFM Clinical Research LLC · Boca Raton, FL
  • Envision Trials LLC · Bonita Springs, FL
  • Clinical Research of Brandon · Brandon, FL
  • Science Connections LLC · Doral, FL
  • Direct Helpers Medical Center, Inc. · Hialeah, FL
  • Homestead Associates in Research Inc · Homestead, FL
  • K2 Medical Research · Maitland, FL
  • Neurology Associates PA · Maitland, FL
  • Advanced Clinical Research Network · Miami, FL
  • Allied Biomedical Research Institute (ABRI), Inc · Miami, FL
  • South Florida Research Phase I-IV · Miami, FL
  • Sunshine Medical Research Studies Inc · Miami, FL
  • Vital Care Research · Miami, FL
  • Wellness Research Center · Miami, FL
  • Charter Research · Orlando, FL
  • Psych Me Medical Research Inc · Tampa, FL
  • Quantum Research Associates Corp · Tampa, FL
  • Premiere Research Institute at Palm Beach Neurology · West Palm Beach, FL

Massachusetts · 1

  • Tufts University School of Medicine · Boston, MA

Nevada · 1

  • Oasis Clinical Research LLC · Las Vegas, NV

New Jersey · 1

  • Bio Behavioral Health · Toms River, NJ

Texas · 1

  • UT Health San Antonio · San Antonio, TX

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