Recruiting
Phase 2

LBDP

Sponsor:

ACADIA Pharmaceuticals Inc.

Code:

NCT07029581

Conditions

Lewy Body Dementia Psychosis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

ACP-204

Placebo

Study Details

Brief summary:

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

Conditions

Lewy Body Dementia Psychosis

Study ID

NCT07029581

Start date

Aug 6, 2025

Status verified date

Sep, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACP-204 30 mg

ACP-204 dose of 30 mg once daily

experimental: ACP-204 60 mg

ACP-204 dose of 60 mg once daily

placebo comparator: Placebo

Placebo once daily

Interventions

ACP-204

Provided as 1 capsule, to be taken orally once daily

Placebo

Provided as 1 capsule, to be taken orally once daily

Primary outcome measure

  • Change from Baseline in SAPS-LBDP total score at Week 6 [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Kristin Kidd

434-841-3162Kristin.kidd@acadia-pharm.com

Becky Howell

848-702-1886bhowell@acadia-pharm.com

Locations

ATP Clinical Research Inc.

Recruiting

Irvine, California, United States, 92612

The University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20057

Humanity Clinical Research, Corp

Recruiting

Aventura, Florida, United States, 33180

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

K2 Medical Research Winter Garden LLC

Recruiting

Clermont, Florida, United States, 34711

University of Florida - Shands

Recruiting

Gainesville, Florida, United States, 32608

K2 Summit Research

Recruiting

Lady Lake, Florida, United States, 32159

Neurology Associates, P. A.

Recruiting

Maitland, Florida, United States, 32751

Homestead Associates in Research Inc

Recruiting

Miami, Florida, United States, 33032

Premier Clinical Research Institute, Inc.

Recruiting

Miami, Florida, United States, 33122

Advanced Clinical Research Network, Corp

Recruiting

Miami, Florida, United States, 33135

MediClear Medical & Research Center, Inc.

Recruiting

Miami, Florida, United States, 33165

Health Synergy Clinical Research, LLC

Recruiting

West Palm Beach, Florida, United States, 33407

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

University of Kansas Medical Center Research Institute Inc.

Recruiting

Kansas City, Kansas, United States, 66160

Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island

Recruiting

Commack, New York, United States, 11725

UNC Hospitals

Recruiting

Chapel Hill, North Carolina, United States, 27517

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University, Energy Advancement and Innovation Center

Recruiting

Columbus, Ohio, United States, 43210

The Movement Disorder Clinic of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74136

Horizon Clinical Research Group

Recruiting

Cypress, Texas, United States, 77429

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

The University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

R and H Clinical Research

Recruiting

Stafford, Texas, United States, 77477

Virginia Commonwealth University (a public institution of higher education)

Recruiting

Richmond, Virginia, United States, 23219

EvergreenHealth

Recruiting

Kirkland, Washington, United States, 98034

More Information

Sponsor

ACADIA Pharmaceuticals Inc.

Last update posted

Aug 24, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ACADIA Pharmaceuticals Inc. on 2026-08-24.