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Alzheimer's Disease PsychosisDrugPhase 2, Phase 3

What this study is

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).

What's being tested

  • ACP-204

    Intervention · DRUG

    ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

  • Placebo

    Intervention · DRUG

    ACP-204 matching placebo

Study details

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
Sponsor
ACADIA Pharmaceuticals Inc.
Conditions
Alzheimer's Disease Psychosis
Enrolling
1,074 people
Starts
2023-11-14
Est. completion
2028-02
Design
Quadruple-blind, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗