Condition: Alzheimer's Disease Psychosis · Sponsor: ACADIA Pharmaceuticals Inc.
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).
This description comes directly from the study's public registry record.
Christine Murphy · 858-465-7480 · cmurphy@acadia-pharm.com
Kristen White · 813-838-6468 · kristen.white@acadia-pharm.com
Always discuss trial participation with your own doctor first.
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| First Excellent Research Group | Doral, Florida, United States | Recruiting |
| New Life Medical Research Center Inc. | Hialeah, Florida, United States | Recruiting |
| Reliable Clinical Research LLC. | Hialeah, Florida, United States | Recruiting |
| Homestead Associates in Research Inc. | Miami, Florida, United States | Recruiting |
+ 136 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06159673