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

Официальное название

A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis

Обзор

This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.

Вмешательства

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

Первичные конечные точки

• Treatment-emergent adverse events [Срок оценки: 52 Weeks]

Вторичные конечные точки (1)

• Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [Срок оценки: 52 Weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 21 центр

• ATP Clinical Research — Costa Mesa
• Neuro-Pain Medical Center — Fresno
• National Institute Of Clinical Research — Garden Grove
• Humanity Clinical Research, Corp — Aventura
• New Life Medical Research Center — Hialeah
• Reliable Clinical Research LLC — Hialeah
• Homestead Associates in Research Inc. — Miami
• Premier Clinical Research Institute Inc — Miami
• … и ещё 13 центров

Бразилия · 9 центров

• Hospital Moinhos de Vento — Porto Alegre
• Hospital Universitario de Brasilia — Brasília
• CECPAR Centro de Estudos Clinicos do Parana — Curitiba
• TrialTech Tecnologia com Pesquisas em Medicamentos — Curitiba
• Inst de Neurologia de Curitiba Hospital Ecoville — Curitiba
• Instituto Mederi de Pesquisa e Saude — Passo Fundo
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Facili - Centro Integrado de Psiquiatria — São Bernardo do Campo
• … и ещё 1 центр

Сербия · 9 центров

• Clinical Center Dr Dragisa Misovic Dedinje — Belgrade
• Institute of Mental Health — Belgrade
• Special Hospital for Cerebrovascular Diseases Sveti Sava — Belgrade
• Special Hospital for Psychiatric Diseases — Gornja Toponica
• Special Hospital for Psychiatric Diseases Kovin — Kovin
• Janjic University Clinical Center Kragujevas — Kragujevac
• Jovanovic University Clinical Centre of Kragujevac — Kragujevac
• Petrovic University Clinical Center Kragujevac — Kragujevac
• … и ещё 1 центр

Мексика · 7 центров

• Hospital Universitario Dr. Jose Eleuterio Gonzalez — Monterrey
• Iecsi S.C. — Monterrey
• Neurociencias Estudios Clinicos — Culiacán
• Centro para el Des de la Med y de Asist Med Esp SC — Culiacán
• Hospital Universitario de Saltillo — Coahuila
• Clinical Research Institute S.C — Estado de México
• BIND Investigaciones S.C. — San Luis Potosí City

Болгария · 6 центров

• ET Dr. Ivo Natsov-AIPSMC in Psychiatry — Cherven Bryag
• DCC Higia — Pazardzhik
• Medical center Medconsult Pleven OOD — Pleven
• Mental Health Centre-Prof. N Shipkovenski EOOD — Sofia
• DCC St. Vrach and St. St. Kuzma and Damian OOD — Sofia
• UMHAT Alexandrovska EAD — Sofia

Чехия · 5 центров

• Fakultni nemocnice u sv. Anny v Brne — Brno
• BRAIN-SOULTHERAPY s.r.o — Kladno
• AD71 s.r.o — Prague
• Clinical s.r.o — Prague
• Vestra Clinics s.r.o. — Rychnov nad Kněžnou

South Korea · 5 центров

• The Catholic University of Korea — Seoul
• Inha University Hospital — Incheon
• Hanyang University Seoul Hospital — Seoul
• Samsung Medical Center — Seoul
• Seoul National University Boramae Medical Center — Seoul

Чили · 4 центра

• Psicomed Estudios Medicos — Antofagasta
• Biomedica Research Group — Santiago
• Especialidades Medicas L y S — Santiago
• CIC de la Universidad Catolica CICUC — Santiago

Италия · 3 центра

• ASST Spedali Civili di Brescia — Brescia
• Azienda Ospedaliera Universitaria OO. RR. S — Salerno
• Azienda Ospedaliera Card. G. Panico — Tricase

Тайвань · 3 центра

• Kaohsiung Municipal Ta-Tung Hospital — Kaohsiung City
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• E-DA Hospital — Kaohsiung City

Франция · 2 центра

• Hôpital Lariboisière — Paris
• Hôpital La Grave — Toulouse

Испания · 2 центра

• Hospital Universitario Virgen Macarena — Seville
• Hospital Provincial de Zamora — Zamora

Идентификаторы

NCT: NCT06194799 · ACP-204-008 · Luminous

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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