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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ATP Clinical Research Inc.
  Irvine, California, United States Recruiting
• The University of Colorado
  Aurora, Colorado, United States Recruiting
• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting
• Humanity Clinical Research, Corp
  Aventura, Florida, United States Recruiting
• Parkinson's Disease and Movement Disorders Center of Boca Raton
  Boca Raton, Florida, United States Recruiting
• K2 Medical Research Winter Garden LLC
  Clermont, Florida, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Kristin Kidd
• Email: Kristin.kidd@acadia-pharm.com
• Phone: 434-841-3162

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ACP-204 extended treatment in Lewy Body Dementia psychosis

  This study tests ACP-204 as a long-term treatment option for adults with Lewy Body Dementia psychosis who have completed prior ACP-204 treatment.

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• A look at why Lewy body conditions cause visual hallucinations

  This study tests brain‑imaging in people with Lewy body diseases who do or don’t experience visual hallucinations, and in healthy volunteers, to see how brain networks might create these images.

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• Evaluating retinal imaging for neurodegenerative diseases

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  Recruiting Duke University · Durham, North Carolina · NCT03233646

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.