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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Lewy Body Dementia Psychosis

In brief

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

Key facts

Study ID

NCT07029581

Run by

ACADIA Pharmaceuticals Inc.

People needed

180

Starts

2025-08-06

Expected to finish

2028-03-01

Last updated by the study team

2026-07-24

Who can join

Age: 55 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The subject's LAR must provide written informed consent.
• 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

You may not qualify if…

• 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

Where it is running

• ATP Clinical Research Inc. — Irvine, California, United States (enrolling)
• Humanity Clinical Research, Corp — Aventura, Florida, United States (enrolling)
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida - Shands — Gainesville, Florida, United States (enrolling)
• K2 Summit Research — Lady Lake, Florida, United States (enrolling)
• Neurology Associates, P. A. — Maitland, Florida, United States (enrolling)
• Homestead Associates in Research Inc — Miami, Florida, United States (enrolling)
• Premier Clinical Research Institute, Inc. — Miami, Florida, United States (enrolling)
• K2 Medical Research Winter Garden LLC — Clermont, Florida, United States (enrolling)
• MediClear Medical & Research Center, Inc. — Miami, Florida, United States (enrolling)
• Health Synergy Clinical Research, LLC — West Palm Beach, Florida, United States (enrolling)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center Research Institute Inc. — Kansas City, Kansas, United States (enrolling)
• Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island — Commack, New York, United States (enrolling)
• UNC Hospitals — Chapel Hill, North Carolina, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• The Ohio State University, Energy Advancement and Innovation Center — Columbus, Ohio, United States (enrolling)
• The Movement Disorder Clinic of Oklahoma — Tulsa, Oklahoma, United States (enrolling)
• Advanced Clinical Research Network, Corp — Miami, Florida, United States (enrolling)
• Horizon Clinical Research Group — Cypress, Texas, United States (enrolling)
• Prolato Clinical Research Center — Houston, Texas, United States (enrolling)
• The University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (enrolling)
• R and H Clinical Research — Stafford, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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