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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Psychosis Associated With Alzheimer's Disease

Interventions

DRUG

ITI-1284

ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration

DRUG

Placebo

Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2027-09-30
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540833 on ClinicalTrials.gov