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Clinical Trials in the USA / NCT07095465
Enrolling by invitation Phase 3

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

NCT07095465 · tracked via the Priya Life Science USA tracker
Sponsor
ACADIA Pharmaceuticals Inc.
Phase
Phase 3
Started
2025-11-14
Last updated
2026-07-24

Condition(s) studied

Lewy Body Dementia Psychosis

Investigational drug(s) / intervention(s)

ACP-204

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)

Trial sites (30)

FacilityCityRegionStatus
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

More ACADIA Pharmaceuticals Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT07095465 on ClinicalTrials.gov ↗ ← All trials in the USA