RecruitingPhase 2

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

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Lead sponsor

ACADIA Pharmaceuticals Inc.

Asset

ACP-204

Listed sites

Recruiting sites

Enrollment

180

estimated

Study population

Lewy body dementia

Key I/E criterion

•Parkinson's disease dementia

Primary endpoint

•SAPS-LBDP total score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Ctis2025-521710-25-00

Org study IDACP-204-012

NCT IDNCT07029581

Timeline

Milestones

Study first posted2025-06-19actual

Study start2025-08-06actual

Last update posted2026-06-30actual

Primary completion2028-02estimated (month precision)

Study completion2028-03estimated (month precision)

Assets

Drug assets

ACP-204

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age55 Years

Maximum age84 Years

SexAll

Healthy volunteersNot 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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Change from Baseline in SAPS-LBDP total score at Week 6

Time frame:6 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.