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NCT06540833 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Psychosis Associated With Alzheimer's Disease, sponsored by Intra-Cellular Therapies.

Recruiting
Registry status
Phase 2
Development phase
370
Enrollment target
20
Study locations

NCT06540833 is a Phase 2 study of Psychosis Associated With Alzheimer's Disease that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 370 participants, below the 470-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 2 states.

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The verdict

NCT06540833, a Phase 2 study of Psychosis Associated With Alzheimer's Disease, is actively recruiting participants, sponsored by Intra-Cellular Therapies.

RECRUITING
Registry status
Phase 2
Development phase
370 participants
Enrollment target
20
Study locations

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 Studied

Psychosis Associated With Alzheimer's Disease

Interventions

  • DRUG Placebo
  • DRUG ITI-1284

Study Locations (20)

Florida

  • Clinical Site - Bonita Springs
  • Clinical Site - Brandon
  • Clinical Site - Coral Springs
  • Clinical Site - Delray Beach
  • Clinical Site - Doral
  • Clinical Site - Homestead
  • Clinical Site - Maitland
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Miami
  • Clinical Site - Orlando
  • Clinical Site - Sarasota

California

  • Clinical Site - Anaheim
  • Clinical Site - Costa Mesa
  • Clinical Site - Lafayette
  • Clinical Site - Los Alamitos
  • Clinical Site - Newport Beach
  • Clinical Site - Orange

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2024-08-15
Est. Completion 2027-10
Phase Phase 2

Sponsor

Intra-Cellular Therapies

37 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06540833

The ClinicalTrials.gov registry entry for NCT06540833 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 470-participant average among 4 other Psychosis Associated With Alzheimer's Disease trials with a reported enrollment target (21% lower). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psychosis Associated With Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06540833 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Florida, California.

Frequently Asked Questions

What is clinical trial NCT06540833 about?

NCT06540833 is a clinical study titled "A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease". 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.

What is the current status of trial NCT06540833?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 370 participants. The study started on 2024-08-15. Estimated completion is 2027-10.

What conditions does trial NCT06540833 study?

This clinical trial studies the following conditions: Psychosis Associated With Alzheimer's Disease.

What interventions are being tested in trial NCT06540833?

The interventions under investigation include: Placebo (DRUG), ITI-1284 (DRUG).

Who is sponsoring clinical trial NCT06540833?

This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06540833 being conducted?

This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.