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NCT06159673 · ClinicalTrials.gov registry record · Phase 2

ACP-204 in Adults With Alzheimer's Disease Psychosis

A Phase 2 study of Alzheimer's Disease Psychosis, sponsored by ACADIA Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
1,074
Enrollment target
20
Study locations

NCT06159673 is a Phase 2 study of Alzheimer's Disease Psychosis that is actively recruiting participants, run by ACADIA Pharmaceuticals. The registered enrollment target is 1,074 participants. The trial reports 20 study locations across 3 states.

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The verdict

NCT06159673, a Phase 2 study of Alzheimer's Disease Psychosis, is actively recruiting participants, sponsored by ACADIA Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
1,074 participants
Enrollment target
20
Study locations

Study Summary

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Interventions

  • DRUG Placebo
  • DRUG ACP-204

Study Locations (20)

Florida

  • Humanity Clinical Research Corp - Aventura
  • Arrow Clinical Trials - Daytona Beach
  • First Excellent Research Group - Doral
  • New Life Medical Research Center Inc. - Hialeah
  • Reliable Clinical Research LLC. - Hialeah
  • Homestead Associates in Research Inc. - Miami
  • Premier Clinical Research Institute, Inc. - Miami
  • Central Miami Medical Institute - Miami
  • Advanced Clinical Research Network, Corp - Miami
  • Verus Clinical Research - Miami
  • Future Care Solution, LLC - Miami
  • MediClear Medical & Research Center, Inc. - Miami
  • ABBA Medical Group LLC - Miami
  • Visionary Investigators Network - Miami

California

  • Advanced Research Center, Inc. - Anaheim
  • ATP Clinical Research - Costa Mesa
  • Neuro-Pain Medical Center - Fresno
  • National Institute of Clinical Research - Garden Grove

Arizona

  • Chandler Clinical Trials - Chandler
  • Clinical Endpoint LLC - Scottsdale

Trial Details

FieldValue
Enrollment Target 1,074 participants
Start Date 2023-11-14
Est. Completion 2028-02
Phase Phase 2

Sponsor

ACADIA Pharmaceuticals

35 total trials

What the Registry Record Tells You About NCT06159673

The ClinicalTrials.gov registry entry for NCT06159673 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 1,074 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ACADIA Pharmaceuticals, which has 35 total studies on file at ClinicalTrials.gov.

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

NCT06159673 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT06159673 about?

NCT06159673 is a clinical study titled "ACP-204 in Adults With Alzheimer's Disease Psychosis". This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiat...

What is the current status of trial NCT06159673?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,074 participants. The study started on 2023-11-14. Estimated completion is 2028-02.

What conditions does trial NCT06159673 study?

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

What interventions are being tested in trial NCT06159673?

The interventions under investigation include: Placebo (DRUG), ACP-204 (DRUG).

Who is sponsoring clinical trial NCT06159673?

This trial is sponsored by ACADIA Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06159673 being conducted?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.