Tests ACP-204 for psychosis in Lewy body dementia
Tests ACP-204 against a placebo in adults with Lewy body dementia psychosis.
Plain-language title generated from the registry record
Registry title: Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Key facts
- Where
- Abington, Aurora, Aventura, Boca Raton, Chapel Hill, Chicago, Clermont, Cleveland, Columbus, Commack, Cypress, Gainesville, Hialeah, Honolulu, Houston, Irvine, Kansas City, Kirkland, Lady Lake, Maitland, Miami, Richmond, San Antonio, Stafford, Tulsa, Washington D.C., and West Palm Beach, United StatesSee the 31 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 84 years old?
Source: NCT07029581, who can take part
Where in United States
- Abington Neurological Associates, LtdAbington, United StatesNo longer taking part
- The University of ColoradoAurora, United StatesTaking people
- Humanity Clinical Research, CorpAventura, United StatesTaking people
- Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, United StatesTaking people
- UNC HospitalsChapel Hill, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- K2 Medical Research Winter Garden LLCClermont, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- The Ohio State University, Energy Advancement and Innovation CenterColumbus, United StatesTaking people
- Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long IslandCommack, United StatesTaking people
- Horizon Clinical Research GroupCypress, United StatesTaking people
- University of Florida - ShandsGainesville, United StatesTaking people
- Reliable Clinical Research LLVHialeah, United StatesTaking people
- Hawaii Pacific NeuroscienceHonolulu, United StatesTaking people
- Prolato Clinical Research CenterHouston, United StatesTaking people
- ATP Clinical Research Inc.Irvine, United StatesTaking people
- University of Kansas Medical Center Research Institute, IncKansas City, United StatesTaking people
- EvergreenHealthKirkland, United StatesTaking people
- K2 Summit ResearchLady Lake, United StatesTaking people
- Neurology Associates, P. A.Maitland, United StatesNo longer taking part
- Advanced Clinical Research Network, CorpMiami, United StatesTaking people
- Homestead Associates in Research Inc.Miami, United StatesTaking people
- MediClear Medical & Research Center, Inc.Miami, United StatesTaking people
- Premier Clinical Research Institute IncMiami, United StatesTaking people
- Verus Clinical ResearchMiami, United StatesTaking people
- Virginia Commonwealth University (a public institution of higher education)Richmond, United StatesTaking people
- The University of Texas Health Science Center San AntonioSan Antonio, United StatesTaking people
- R and H Clinical ResearchStafford, United StatesTaking people
- The Movement Disorder Clinic of OklahomaTulsa, United StatesTaking people
- Georgetown UniversityWashington D.C., United StatesTaking people
- Health Synergy Clinical Research, LLCWest Palm Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT07029581EU 2025-521710-25-00
- Record updated
- 4 November 2026
- Original description
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.Read full original descriptionShow less
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Inclusion: 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.
Exclusion: 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; 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; Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline).