2022-502268-18-00已完成3 期
I5T-MC-AACQ: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults with Early Symptomatic Alzheimer’s Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 9
- 主要终点
- Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
研究概览
简要总结
To assess the effect of alternative donanemab dosing regimens versus the standard donanemab dosing regimen on ARIA-E frequency
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must have gradual and progressive change in memory function reported by participants or informants for 6 months
- •Participants must meet 18F flortaucipir PET scan (central read) criteria does not apply to participants in the safety cohort
- •Participants must have meet 18F florbetapir PET scan (central read) criteria
排除标准
- •Participants must not have contraindication to MRI or PET scans
- •Participants must not receive current treatment with immunoglobulin G (IgG) therapy
结局指标
主要结局
Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (9)
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