Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

Официальное название

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Обзор

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

Подробное описание

Study Website: https://illumerastudy.com/

Вмешательства

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

Первичные конечные точки

• Change from Baseline in SAPS-LBDP total score at Week 6 [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
• Can 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 must provide written informed consent.
• The subject must provide written (if capable) informed assent per local regulations.
• Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium).
• Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association

Критерии исключения

• Is in hospice, is receiving end-of-life palliative care, or is bedridden
• Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
• Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
• Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures
• Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 28 центров

• ATP Clinical Research Inc. — Irvine
• Georgetown University — Washington D.C.
• Humanity Clinical Research, Corp — Aventura
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton
• K2 Medical Research Winter Garden LLC — Clermont
• University of Florida - Shands — Gainesville
• K2 Summit Research — Lady Lake
• Neurology Associates, P. A. — Maitland
• … и ещё 20 центров

Франция · 10 центров

• CHU de Toulouse- Hopital Purpan — Toulouse
• Gérontopôle Centre de Recherche Clinique — Toulouse
• Hopital Roger Salengro - CHU Lille — Lille
• Hôpital Lariboisière, Histologie et CMRR — Paris
• Hôpital des Chapennes — Villeurbanne
• Hopital Neurologique Bron — Bron
• Hopital BROCA — Paris
• CHU Strasbourg-Hopital Hautepierre — Strasbourg
• … и ещё 2 центра

Болгария · 7 центров

• Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Nat — Cherven Bryag
• UMHAT Sv Georgi EAD — Plovdiv
• Medical Center SV.Naum — Sofia
• DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD — Sofia
• UMHAT "Alexandrovska" EAD — Sofia
• Medical Center Detsko Zdrave Branch Maestro Kanev — Sofia
• DCC Mladost M- Varna, OOD — Varna

Чехия · 5 центров

• Fakultni nemocnice u sv. Anny v Brne — Brno
• NEUROHK s.r.o. Poliklinika Chocen a.s. — Choceň
• Vseobecna fakultni nemocnice v Praze — Prague
• Neuropsychiatrie s.r.o. — Prague
• Vestra Clinics s.r.o — Rychnov nad Kněžnou

Италия · 5 центров

• Azienda Ospedaliera Univerrsitaria — Naples
• Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona — Salerno
• Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia
• Università Campus Bio-Medico di Roma — Roma
• Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, — Roma

Сербия · 4 центра

• Institute of Mental Health — Belgrade
• University Clinical Center of Serbia — Belgrade
• University Clinical Hospital Center Zvezdara — Belgrade
• University Clinical Center Kragujevac — Kragujevac

Идентификаторы

NCT: NCT07029581 · ACP-204-012 · 2025-521710-25-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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