Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Trial Parameters
Brief Summary
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Eligibility Criteria
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 criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association Exclusion Criteria: * Is in hospice, is receiving end-of-life palliative care,