Alzheimer's Disease Psychosis Clinical Trial
Official title:
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 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).
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| 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 |