NCT07571161招募中3 期
A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 30
- 主要终点
- Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Donanemab
Experimental
Donanemab administered intravenously (IV)
干预措施: Donanemab (Drug)
Placebo
Placebo Comparator
Placebo administered IV
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
时间窗: Baseline Up to Week 156
次要结局
- Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab(Baseline Up to Week 156)
- PK: Trough Concentrations of Serum Donanemab(Baseline Up to Week 156)
- Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)(Baseline, Week 52)
- Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)(Baseline Up to Week 156)
研究者
研究点 (30)
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