Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

Официальное название

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Обзор

The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD). The study drug will be administered intravenously (IV) (into a vein in the arm). The study will last up to approximately 156 weeks, excluding screening.

Вмешательства

• Препарат Donanemab
  Administered IV
• Препарат Placebo
  Administered IV

Первичные конечные точки

• Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS) [Срок оценки: Baseline Up to Week 156]

Вторичные конечные точки (4)

• Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217) [Срок оценки: Baseline, Week 52]
• Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB) [Срок оценки: Baseline Up to Week 156]
• Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab [Срок оценки: Baseline Up to Week 156]
• PK: Trough Concentrations of Serum Donanemab [Срок оценки: Baseline Up to Week 156]

Критерии участия

Критерии включения

• A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)
• Clinical Dementia Rating-Global Score (CDR-GS) of 0
• A plasma P-tau result consistent with amyloid pathology
• A reliable study partner who:

• Provides written informed consent to participate in the study in their role
• Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities
• Is of legal age (18 years of age or older) to consent
• Is available to conduct functional scales
• Have adequate literacy, vision, and hearing for neuropsychological testing

Критерии исключения

• Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition
• Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer
• Have received active or passive immunization against amyloid beta (Aβ) in any other study
• Have current or prior use of prescription medications for treatment of MCI or AD
• Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants
• Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 30 центров

• Peking University Third Hospital — Пекин
• The First Hospital of Jilin University — Changchun
• Xiangya Hospital Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду
• 2nd Affiliated Hospital Chongqing Medical University — Чунцин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Fujian Medical University Union Hospital — Фучжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• … и ещё 22 центра

Идентификаторы

NCT: NCT07571161 · 27822 · I5T-MC-AACW

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗