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RecruitingPhase 2

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

ACADIA Pharmaceuticals Inc. · NCT07029581

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–84 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
180
US sites recruiting
28
Study start
August 6, 2025
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: ACP-204; Placebo

Conditions: Lewy Body Dementia Psychosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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:
  • 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 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

Recruiting US locations

Study contacts (from the official record)

  • Kristin Kidd · 434-841-3162 · Kristin.kidd@acadia-pharm.com
  • Becky Howell · 848-702-1886 · bhowell@acadia-pharm.com
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Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body… (NCT07029581) | Bored Studies