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

Launched by ACADIA PHARMACEUTICALS INC. · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ACP-204 to see if it is safe and effective in treating psychosis (such as hallucinations or delusions) in people with Lewy Body Dementia, a type of dementia that affects thinking, movement, and behavior. The study will last about 6 weeks and will compare ACP-204 to a placebo (a dummy treatment) to see if the medicine helps reduce symptoms.

People who might be eligible to join are men or women between 55 and 85 years old who have been diagnosed with Lewy Body Dementia or Parkinson’s disease dementia and have symptoms of psychosis related to their dementia. Participants must be able to give permission to join the study or have a legal representative do so if they cannot. Those who are very ill, bedridden, or have other serious health problems may not be able to participate. If you join the study, you will be randomly assigned to receive either ACP-204 or a placebo without knowing which one, and your health will be closely monitored throughout the 6 weeks to see how you respond to the treatment. This study has not started recruiting yet, but it aims to find better ways to help people manage the challenging symptoms of Lewy Body Dementia psychosis.

Gender

ALL

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, or is bedridden
• • Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
• • Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
• • Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures
• • Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT