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NCT06159673 · ClinicalTrials.gov record · last posted 2026-07-24

ACP-204 in Adults With Alzheimer's Disease Psychosis

StatusRecruiting
PhasePhase 2/3
Started2023-11-14
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from the ClinicalTrials.gov record
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).

Protocol amendment history 1 change detected by DataLookout

2026-07-25
minor
Trial sites expanded: 145 → 148 locations
Trial Details
NCT Number NCT06159673
Lead Sponsor ACADIA Pharmaceuticals Inc.
Conditions Alzheimer's Disease Psychosis
Enrollment 1,074 participants
Start Date 2023-11-14
Primary Completion 2028-01 (estimated)
Study Completion 2028-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-24