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 restrictionWhat 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.
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