The EDC is live today — see what ships now
All studies
NCT07095465From ClinicalTrials.govRecruiting

Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis

52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

  • Lewy Body Dementia Psychosis

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
ACADIA Pharmaceuticals Inc.
Enrolment target
126
Started
14 November 2025
Main results due
February 2029
Study sites
32
Registry updated
29 September 2026

Can you take part?

  • Ages 55 years to 84 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Study sites(32)

  • ATP Clinical Research Inc.

    Irvine, California, 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

  • Advanced Clinical Research Network, Corp

    Miami, Florida, United States

    Recruiting

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, United States

    Recruiting

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, United States

    Recruiting

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, United States

    Recruiting

  • University of Kansas Medical Center Research Institute Inc.

    Kansas City, Kansas, United States

    Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island

    Commack, New York, United States

    Recruiting

  • The Ohio State University, Energy Advancement and Innovation Center

    Columbus, Ohio, United States

    Recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, United States

    Recruiting

  • Horizon Clinical Research Group

    Cypress, Texas, United States

    Recruiting

  • The University of Texas Health Science Center San Antonio

    San Antonio, Texas, United States

    Recruiting

  • R and H Clinical Research

    Stafford, Texas, United States

    Recruiting

  • Virginia Commonwealth University (a public institution of higher education)

    Richmond, Virginia, United States

    Recruiting

  • EvergreenHealth

    Kirkland, Washington, United States

    Recruiting

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

    Cherven Bryag, Bulgaria

    Recruiting

  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

    Sofia, Bulgaria

    Recruiting

  • UMHAT "Alexandrovska" EAD

    Sofia, Bulgaria

    Recruiting

  • DCC Mladost M- Varna, OOD

    Varna, Bulgaria

    Recruiting

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, Czechia

    Recruiting

  • NEUROHK s.r.o. Poliklinika Chocen a.s.

    Choceň, Czechia

    Recruiting

  • Vestra Clinics s.r.o

    Rychnov nad Kněžnou, Czechia

    Recruiting

  • CHU Tours- Hopital Bretonneau

    Tours, Cedex 9, France

    Recruiting

  • Hopital Neurologique Bron

    Bron, Rhone, France

    Recruiting

  • CHU Strasbourg-Hopital Hautepierre

    Strasbourg, France

    Recruiting

  • Azienda Ospedaliera Univerrsitaria

    Naples, Napoli, Italy

    Recruiting

  • Università Campus Bio-Medico di Roma

    Roma, Roma, Italy

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia

    Roma, Roma, Italy

    Recruiting

  • Institute of Mental Health

    Belgrade, Serbia

    Recruiting

Showing 32 of 32 sites. 32 of the 32 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07095465. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis | Trialion