ACP-204 extended treatment in Lewy Body Dementia psychosis

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 is a 52-week, open-label extension of ACP-204 for adults with Lewy Body Dementia psychosis. Participants who completed the previous ACP-204-012 study and meet eligibility will receive ACP-204 with ongoing monitoring. The study emphasizes long-term safety and tolerability while continuing to assess clinical outcomes. It is conducted at multiple sites with a study partner or caregiver involved in visits and consent processes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
* Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
* Can complete all study visits with a study partner/caregiver
* Can understand the nature of the study and protocol requirements and 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 (or study partner/caregiver, if local regulations allow) must provide written informed consent.
  2. The subject must provide written (if capable) informed assent per local regulations
* If the subject is a female, she must be of nonchildbearing potential
* If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:

  1. Refrain from donating sperm, AND
  2. Either

     * Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
     * Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method

Exclusion Criteria:

* Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
* Is in hospice, is receiving end-of-life palliative care, or is bedridden
* Has a heart rate \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
* Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
* Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:

  1. jeopardize the safe participation of the subject in this study; OR
  2. interfere with the conduct or interpretation of safety or efficacy evaluations in the study
* Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
* Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
* Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction

Where it's running

• ATP Clinical Research Inc.
  Irvine, California, 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 Summit Research
  Lady Lake, Florida, United States Recruiting
• Homestead Associates in Research Inc
  Miami, Florida, United States Recruiting

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 for psychosis in Lewy body dementia (Phase 2)

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

  Recruiting at 58 sites Phase 2 ACADIA Pharmaceuticals Inc. · Irvine, California and 61 other locations · NCT07029581

• Automated language analysis to help diagnose neurodegenerative diseases

  A multilingual AI-powered language test is being tried to see if speech and language patterns can help differentiate Alzheimer’s, frontotemporal dementia, Lewy body dementia, and Parkinson’s from healthy aging.

  Recruiting Istituti Clinici Scientifici Maugeri SpA · Bari · NCT07906769

• 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.

  Recruiting NYU Langone Health · New York, New York · NCT07849413

• Pulsed electromagnetic field treatment for dementia patients

  This study is testing a pulsed electromagnetic device to see if it can help people with mild to moderate Alzheimer's disease improve their thinking and memory over 120 days.

  Recruiting Herrick Medical LLC · Boca Raton, Florida · NCT06862557

• Exergaming for improving health in dementia patients

  This study is testing if playing active dance video games three times a week can help improve movement, thinking skills, and mood in older adults with dementia living in care facilities.

  Recruiting Eastern Switzerland University of Applied Sciences · Wetzikon, Canton of Zurich · NCT06631742

• Evaluating retinal imaging for neurodegenerative diseases

  This study is testing if special eye scans can help spot early signs of neurodegenerative diseases like Alzheimer's and Parkinson's in people.

  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.