Phase 2 Study of ACP-204 for Treating Psychosis in Adults with Lewy Body Dementia Aged 55 to 84

What this Trial Is About

Researchers are evaluating the efficacy and safety of ACP-204 in adults aged 55 to 84 years with Lewy Body Dementia Psychosis LBDP. This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study designed to assess the impact of ACP-204 on psychosis symptoms associated with LBDP. The study aims to provide insights into treatment options for this condition with significant cognitive and psychiatric features. Participants are randomly assigned to one of three groups ACP-204 30 mg once daily, ACP-204 60 mg once daily, or placebo once daily. The study treatment is provided as capsules taken orally each day over a 6-week period. The trial is conducted with quadruple masking to maintain blinding of participants and researchers. The primary focus is to compare changes in psychosis symptoms using the SAPS-LBDP total score over the 6 weeks of treatment. During the study, participants will be monitored closely with regular assessments to evaluate changes in psychosis symptoms. Researchers will collect data on safety and efficacy throughout the 6-week treatment period. Participants must be able to provide consent or have a legally authorized representative assist with consent. The overall duration of participation is approximately 6 weeks, with careful monitoring to ensure adherence and safety.

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis