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ACP-204 for psychosis in Lewy body dementia (Phase 2)

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

Phase 2 Interventional ACADIA Pharmaceuticals Inc. · NCT07029581

This 6-week, randomized, double-blind trial tests whether ACP-204 reduces psychosis symptoms in people aged 55–84 with Lewy body dementia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages55 Years to 84 Years
SexAll
SponsorACADIA Pharmaceuticals Inc. Industry-sponsored
Locations54 sites (Irvine, California and 53 other locations)
Trial IDNCT07029581 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled parallel-group Phase 2 trial enrolls adults with Lewy body dementia psychosis to receive ACP-204 or placebo for six weeks. Participants must meet established clinical criteria for dementia with Lewy bodies or Parkinson's disease dementia and criteria for psychosis in neurocognitive disorder, and must be 55–84 years old. The study measures changes in psychosis symptoms and closely monitors safety and tolerability over the treatment period. Assessments occur at baseline and at scheduled visits during the six-week treatment window at U.S. clinical sites.

Who should consider this trial

Good fit: Ideal candidates are people aged 55–84 with clinically diagnosed Lewy body dementia or Parkinson's disease dementia who meet criteria for psychosis in neurocognitive disorder and who can provide informed consent or have a legally authorized representative.

Not a fit: Patients in hospice or receiving end-of-life palliative care, those outside the age range, or those without LBD-related psychosis are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, ACP-204 could reduce hallucinations and delusions and improve safety and quality of life for people with Lewy body dementia psychosis.

How similar studies have performed: Related serotonin-targeting drugs such as pimavanserin have shown benefit in Parkinson's disease psychosis, but evidence specifically in Lewy body dementia psychosis remains limited.

Eligibility criteria

Show full inclusion / exclusion 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:

  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

Where this trial is running

Irvine, California and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lewy Body Dementia Psychosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.