Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
| Condition(s) | Lewy Body Dementia Psychosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP. |
| Who can participate | Inclusion Criteria: * Male or female ≥55 years to \<85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting * Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: 1. The subject's LAR must provide written informed consent. 2. The subject must provide written (if capable) informed assent per local regulations. * Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium). * Meets the revised crite |
| Ages | 55 Years to 84 Years |
| Sex | All |
| Lead sponsor | ACADIA Pharmaceuticals Inc. |
| Locations | Irvine, California, United States; Washington D.C., District of Columbia, United States; Aventura, Florida, United States; Boca Raton, Florida, United States; Clermont, Florida, United States; Gainesville, Florida, United States (+50 more sites) |
| Start date | 2025-08-06 |
| NCT ID | NCT07029581 |
| Official listing | https://clinicaltrials.gov/study/NCT07029581 |