Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
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
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-10 -> 2027-12-28 2026-07-07
minor Completion pushed: 2027-11 -> 2027-12-28 2026-07-07
Trial Details
NCT Number NCT06651567
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Agitation Associated With Alzheimer's Dementia
Enrollment 320 participants
Start Date 2024-10-22
Primary Completion 2027-12-28 (estimated)
Study Completion 2027-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-31