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Clinical Trial 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 42 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).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06159673
Study type Interventional
Source ACADIA Pharmaceuticals Inc.
Contact Christine Murphy
Phone 858-465-7480
Email cmurphy@acadia-pharm.com
Status Recruiting
Phase Phase 2/Phase 3
Start date November 14, 2023
Completion date February 2028

See also
  Status Clinical Trial Phase
Completed NCT02035553 - A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis Phase 2
Enrolling by invitation NCT06194799 - ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study Phase 3