ACP-204: Provided as 1 capsule, to be taken orally once daily
Study summary
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Eligibility
Sex
ALL
Min age
55 Years
Max age
84 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of subjects who experience treatment-emergent adverse events (TEAEs) — 52 weeks
Trial sites (30)
Facility
City
Region
Status
ATP Clinical Research Inc.
Irvine
California
Humanity Clinical Research, Corp
Aventura
Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
Florida
K2 Summit Research
Lady Lake
Florida
Homestead Associates in Research Inc
Miami
Florida
Advanced Clinical Research Network, Corp
Miami
Florida
MediClear Medical & Research Center, Inc.
Miami
Florida
Health Synergy Clinical Research, LLC
West Palm Beach
Florida
Hawaii Pacific Neuroscience
Honolulu
Hawaii
University of Kansas Medical Center Research Institute Inc.
Kansas City
Kansas
Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island
Commack
New York
The Ohio State University, Energy Advancement and Innovation Center
Columbus
Ohio
The Movement Disorder Clinic of Oklahoma
Tulsa
Oklahoma
Horizon Clinical Research Group
Cypress
Texas
R and H Clinical Research
Stafford
Texas
Virginia Commonwealth University (a public institution of higher education)
Richmond
Virginia
EvergreenHealth
Kirkland
Washington
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag
Bulgaria
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia
Bulgaria
DCC Mladost M- Varna, OOD
Varna
Bulgaria
Fakultni Nemocnice u sv. Anny v Brne
Brno
Czechia
NEUROHK s.r.o. Poliklinika Chocen a.s.
Choceň
Czechia
Vestra Clinics s.r.o
Rychnov nad Kněžnou
Czechia
CHU Tours- Hopital Bretonneau
Tours
Cedex 9
Hopital Neurologique Bron
Bron
Rhone
CHU Strasbourg-Hopital Hautepierre
Strasbourg
France
Azienda Ospedaliera Univerrsitaria
Naples
Napoli
Università Campus Bio-Medico di Roma
Roma
Roma
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia
Roma
Roma
Institute of Mental Health
Belgrade
Serbia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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