Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-09 -> 2028-09-30 2026-07-07
minor Completion pushed: 2027-10 -> 2028-12-29 2026-07-07
Trial Details
NCT Number NCT06540833
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Psychosis Associated With Alzheimer's Disease
Enrollment 370 participants
Start Date 2024-08-15
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-31