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

Официальное название

52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Обзор

A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Подробное описание

Study Website: https://illumerastudy.com/

Вмешательства

• Препарат ACP-204
  Provided as 1 capsule, to be taken orally once daily

Первичные конечные точки

• Proportion of subjects who experience treatment-emergent adverse events (TEAEs) [Срок оценки: 52 weeks]

Критерии участия

Критерии включения

• 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:

• The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
• 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:

• Refrain from donating sperm, AND
• 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

Критерии исключения

• 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:

• jeopardize the safe participation of the subject in this study; OR
• 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

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 · 17 центров

• ATP Clinical Research Inc. — Irvine
• Humanity Clinical Research, Corp — Aventura
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton
• K2 Summit Research — Lady Lake
• Homestead Associates in Research Inc — Miami
• Advanced Clinical Research Network, Corp — Miami
• MediClear Medical & Research Center, Inc. — Miami
• Health Synergy Clinical Research, LLC — West Palm Beach
• … и ещё 9 центров

Болгария · 3 центра

• Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Nat — Cherven Bryag
• DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD — Sofia
• DCC Mladost M- Varna, OOD — Varna

Чехия · 3 центра

• Fakultni Nemocnice u sv. Anny v Brne — Brno
• NEUROHK s.r.o. Poliklinika Chocen a.s. — Choceň
• Vestra Clinics s.r.o — Rychnov nad Kněžnou

Франция · 3 центра

• CHU Tours- Hopital Bretonneau — Tours
• Hopital Neurologique Bron — Bron
• CHU Strasbourg-Hopital Hautepierre — Strasbourg

Италия · 3 центра

• Azienda Ospedaliera Univerrsitaria — Naples
• Università Campus Bio-Medico di Roma — Roma
• Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, — Roma

Сербия · 1 центр

• Institute of Mental Health — Belgrade

Идентификаторы

NCT: NCT07095465 · ACP-204-013 · 2025-521711-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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