ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension 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.

Interventions

• ACP-204 · DRUG

  ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (76)

• 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, Brazil
• 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
• Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia
• BRAIN-SOULTHERAPY s.r.o, Kladno, Czechia
• AD71 s.r.o, Prague, Czechia
• Clinical s.r.o, Prague, Czechia
• Vestra Clinics s.r.o., Rychnov nad Kněžnou, Czechia
• Hôpital Lariboisière, Paris, France
• Hôpital La Grave, Toulouse, France
• ASST Spedali Civili di Brescia, Brescia, Italy
• Azienda Ospedaliera Universitaria OO. RR. S, Salerno, Italy
• Azienda Ospedaliera Card. G. Panico, Tricase, Italy
• Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Neuvo Leon, Mexico
• Iecsi S.C., Monterrey, Nuevo León, Mexico
• Neurociencias Estudios Clinicos, Culiacán, Sinaloa, Mexico
• Centro para el Des de la Med y de Asist Med Esp SC, Culiacán, Sinaloa, Mexico
• Hospital Universitario de Saltillo, Coahuila, Mexico
• Clinical Research Institute S.C, Estado de México, Mexico
• BIND Investigaciones S.C., San Luis Potosí City, Mexico
• Clinical Center Dr Dragisa Misovic Dedinje, Belgrade, Serbia
• Institute of Mental Health, Belgrade, Serbia
• Special Hospital for Cerebrovascular Diseases Sveti Sava, Belgrade, Serbia
• Special Hospital for Psychiatric Diseases, Gornja Toponica, Serbia
• Special Hospital for Psychiatric Diseases Kovin, Kovin, Serbia
• Janjic University Clinical Center Kragujevas, Kragujevac, Serbia
• Jovanovic University Clinical Centre of Kragujevac, Kragujevac, Serbia
• Petrovic University Clinical Center Kragujevac, Kragujevac, Serbia
• University Clinical Center Nis, Niš, Serbia
• The Catholic University of Korea, Seoul, Republic of Korea, South Korea
• Inha University Hospital, Incheon, South Korea
• Hanyang University Seoul Hospital, Seoul, South Korea
• Samsung Medical Center, Seoul, South Korea
• Seoul National University Boramae Medical Center, Seoul, South Korea
• Hospital Universitario Virgen Macarena, Seville, Spain
• Hospital Provincial de Zamora, Zamora, Spain
• Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung City, Taiwan
• Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan
• E-DA Hospital, Kaohsiung City, Taiwan