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A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of 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 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).
Age
55 - 95 years
Sex
ALL
Healthy Volunteers
No
Chandler Clinical Trials
Chandler, Arizona, United States
Clinical Endpoint LLC
Scottsdale, Arizona, United States
Advanced Research Center, Inc.
Anaheim, California, United States
ATP Clinical Research
Costa Mesa, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
National Institute of Clinical Research
Garden Grove, California, United States
Humanity Clinical Research Corp
Aventura, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
First Excellent Research Group
Doral, Florida, United States
New Life Medical Research Center Inc.
Hialeah, Florida, United States
Start Date
November 14, 2023
Primary Completion Date
January 1, 2028
Completion Date
February 1, 2028
Last Updated
March 19, 2026
1,074
ESTIMATED participants
ACP-204
DRUG
Placebo
DRUG
Lead Sponsor
ACADIA Pharmaceuticals Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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