Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
NCT ID: NCT07029581
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-08-06
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACP-204 30 mg
ACP-204 dose of 30 mg once daily
ACP-204
Provided as 1 capsule, to be taken orally once daily
ACP-204 60 mg
ACP-204 dose of 60 mg once daily
ACP-204
Provided as 1 capsule, to be taken orally once daily
Placebo
Placebo once daily
Placebo
Provided as 1 capsule, to be taken orally once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACP-204
Provided as 1 capsule, to be taken orally once daily
Placebo
Provided as 1 capsule, to be taken orally once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
55 Years
84 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ACADIA Pharmaceuticals Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ATP Clinical Research Inc.
Irvine, California, United States
Humanity Clinical Research, Corp
Aventura, Florida, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
K2 Medical Research Winter Garden LLC
Clermont, Florida, United States
K2 Summit Research
Lady Lake, Florida, United States
Neurology Associates, P. A.
Maitland, Florida, United States
Homestead Associates in Research Inc
Miami, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Advanced Clinical Research Network, Corp
Miami, Florida, United States
MediClear Medical & Research Center, Inc.
Miami, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
University of Kansas Medical Center Research Institute Inc.
Kansas City, Kansas, United States
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
The Ohio State University, Energy Advancement and Innovation Center
Columbus, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Abington Neurological Associates, LTD
Abington, Pennsylvania, United States
Horizon Clinical Research Group
Cypress, Texas, United States
The University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
R and H Clinical Research
Stafford, Texas, United States
Virginia Commonwealth University (a public institution of higher education)
Richmond, Virginia, United States
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, , Bulgaria
UMHAT Sv Georgi EAD
Plovdiv, , Bulgaria
Medical Center SV.Naum
Sofia, , Bulgaria
DCC Mladost M- Varna, OOD
Varna, , Bulgaria
NEUROHK s.r.o. Poliklinika Chocen a.s.
Choceň, , Czechia
Vestra Clinics s.r.o
Rychnov nad Kněžnou, , Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-521710-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
ACP-204-012
Identifier Type: -
Identifier Source: org_study_id