Clinical Trials in Italy / NCT06194799
Enrolling by invitation
Phase 3
ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
NCT06194799 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Alzheimer's Disease Psychosis
Investigational drug(s) / intervention(s)
ACP-204: ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule
Study summary
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
Eligibility
Inclusion Criteria:
* Subject has successfully completed ACP-204-006 study
* Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential
* Subject has a designated study partner/caregiver
* Subjects are able to complete all study visits with a study partner/caregiver
* Signed inform consent form with a caregiver or legal representative
Exclusion Criteria:
* Requires treatment with a medication prohibited by the protocol
* Is in hospice and receiving end-of-life palliative care, or has become bedridden
* Unstable clinically significant medical condition other than AD
* Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Primary outcome measure(s)
- Treatment-emergent adverse events — 52 Weeks
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.
Trial sites (76)
| Facility | City | Region | Status |
|---|---|---|---|
| ATP Clinical Research | Costa Mesa | California | |
| Neuro-Pain Medical Center | Fresno | California | |
| National Institute Of Clinical Research | Garden Grove | California | |
| Humanity Clinical Research, Corp | Aventura | Florida | |
| New Life Medical Research Center | Hialeah | Florida | |
| Reliable Clinical Research LLC | Hialeah | Florida | |
| Homestead Associates in Research Inc. | Miami | Florida | |
| Premier Clinical Research Institute Inc | Miami | Florida | |
| Advanced Clinical Research | Miami | Florida | |
| Verus Clinical Research | Miami | Florida | |
| Quantum Clinical Trials | Miami | Florida | |
| Future Care Solution, LLC | Miami | Florida | |
| MediClear Medical & Research Center, Inc. | Miami | Florida | |
| ABBA Medical Research LLC | Miami | Florida | |
| New Med Research | Miami Gardens | Florida | |
| Floridian Neuroscience Institute | Miami Lakes | Florida | |
| Abington Neurological Associates | Abington | Pennsylvania | |
| Horizon Clinical Research Group | Cypress | Texas | |
| Uni Texas Health Science Center | Houston | Texas | |
| Clinical Trial Network LLC | Houston | Texas | |
| Kaleidoscope Clinical Research | Houston | Texas | |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | |
| Hospital Universitario de Brasilia | Brasília | Brazil | |
| CECPAR Centro de Estudos Clinicos do Parana | Curitiba | Brazil | |
| TrialTech Tecnologia com Pesquisas em Medicamentos | Curitiba | Brazil | |
| Inst de Neurologia de Curitiba Hospital Ecoville | Curitiba | Brazil | |
| Instituto Mederi de Pesquisa e Saude | Passo Fundo | Brazil | |
| Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro | Brazil | |
| Facili - Centro Integrado de Psiquiatria | São Bernardo do Campo | Brazil | |
| BR Trials-Ensaios Clinicos e Consultoria | São Paulo | Brazil | |
| ET Dr. Ivo Natsov-AIPSMC in Psychiatry | Cherven Bryag | Bulgaria | |
| DCC Higia | Pazardzhik | Bulgaria | |
| Medical center Medconsult Pleven OOD | Pleven | Bulgaria | |
| Mental Health Centre-Prof. N Shipkovenski EOOD | Sofia | Bulgaria | |
| DCC St. Vrach and St. St. Kuzma and Damian OOD | Sofia | Bulgaria | |
| UMHAT Alexandrovska EAD | Sofia | Bulgaria | |
| Psicomed Estudios Medicos | Antofagasta | Chile | |
| Biomedica Research Group | Santiago | Chile | |
| Especialidades Medicas L y S | Santiago | Chile | |
| CIC de la Universidad Catolica CICUC | Santiago | Chile |
+ 36 more sites — see the full list on the official registry below.
More ACADIA Pharmaceuticals Inc. trials in Italy
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 NCT06194799 on ClinicalTrials.gov ↗ ← All trials in Italy