Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 3

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

NCT07095465 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2025-11-14
Last updated
2026-09-29

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)

  • Proportion of subjects who experience treatment-emergent adverse events (TEAEs) — 52 weeks

Trial sites (32)

FacilityCityRegionStatus
ATP Clinical Research Inc. Irvine California Recruiting
Humanity Clinical Research, Corp Aventura Florida Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida Recruiting
K2 Summit Research Lady Lake Florida Recruiting
Homestead Associates in Research Inc Miami Florida Recruiting
Advanced Clinical Research Network, Corp Miami Florida Recruiting
MediClear Medical & Research Center, Inc. Miami Florida Recruiting
Health Synergy Clinical Research, LLC West Palm Beach Florida Recruiting
Hawaii Pacific Neuroscience Honolulu Hawaii Recruiting
University of Kansas Medical Center Research Institute Inc. Kansas City Kansas 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 Recruiting
The Ohio State University, Energy Advancement and Innovation Center Columbus Ohio Recruiting
The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma Recruiting
Horizon Clinical Research Group Cypress Texas Recruiting
The University of Texas Health Science Center San Antonio San Antonio Texas Recruiting
R and H Clinical Research Stafford Texas Recruiting
Virginia Commonwealth University (a public institution of higher education) Richmond Virginia Recruiting
EvergreenHealth Kirkland Washington 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 Recruiting
Hopital Neurologique Bron Bron Rhone Recruiting
CHU Strasbourg-Hopital Hautepierre Strasbourg France Recruiting
Azienda Ospedaliera Univerrsitaria Naples Napoli Recruiting
Università Campus Bio-Medico di Roma Roma Roma Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia Roma Roma Recruiting
Institute of Mental Health Belgrade Serbia Recruiting
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 Italy