NCT07602582招募中3 期
An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 59
研究概览
简要总结
The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.
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, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed study AACM Addendum
- •Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- •Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.
- •Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- •Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.
- •Contraindication to florbetapir F 18 PET.
- •Have had history of amyloid-targeting therapy treatment outside donanemab trials.
- •Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.
研究组 & 干预措施
Donanemab
Experimental
Donanemab administered intravenously (IV)
干预措施: Donanemab (Drug)
Placebo
Placebo Comparator
Placebo IV
干预措施: Placebo (Drug)
研究者
研究点 (59)
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