ACP-204 in Adults With Alzheimer's Disease Psychosis
Status:
Recruiting
Trial end date:
2028-02-01
Target enrollment:
Participant gender:
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).