Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up. The data cut aligns with the primary publication: Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239. PMID: 37459141; PMCID: PMC10352931.

本研究旨在评估研究药物多奈单抗（donanemab）在早期阿尔茨海默病受试者中的安全性与有效性。另有部分受试者将被纳入附加安全性队列，该队列受试者将接受开放标签的多奈单抗给药。曾在主研究中接受多奈单抗给药的试验受试者，将被纳入为期3年的随访附加研究，此随访阶段无需给予研究药物。本研究的数据截点与首次发表的文献保持一致：《早期症状性阿尔茨海默病患者使用多奈单抗：TRAILBLAZER-ALZ 2随机临床试验》，刊载于《美国医学会杂志》（JAMA），2023年8月8日，第330卷第6期，第512-527页，DOI: 10.1001/jama.2023.13239，PMID: 37459141，PMCID: PMC10352931。