数据日期 2026-10-29 · 生成时间 2026-10-29 06:03
研究问题
Alzheimer's disease (AD) is the most common cause of dementia, accounting for 60% to 70% of all dementia cases worldwide.
方法
We conducted an ongoing phase 4, multicenter, prospective, real‐world study designed to evaluate the effectiveness and safety of lecanemab in participants diagnosed with early AD (i.e., mild cognitive impairment [MCI] due to AD or mild dementia due to AD), defined according to National Institute on Aging–Alzheimer's Association criteria, who met the clinical indication for lecanemab across 20 hospitals in Jiangsu Province, China.；Consecutive enrollment began in June 2024, and participants received intravenous lecanemab 10 mg/kg every 2 weeks.；Because enrollment was rolling, not every participant had reached each scheduled visit at the interim data cutoff of February 21, 2026.；Written informed consent was obtained from all participants prior to enrollment.
核心结论
The mean age of the cohort was 69.54 years (SD = 8.66); 61.9% were female, and 56.6% were APOE ε4 carriers. ‖ 结论：The study protocol was reviewed and approved by the Ethics Committees of all participating medical centers (ethical approval number 2024‐746‐01).
局限
First, the ongoing rolling cohort had only 68 patients complete 12 months of treatment, limiting long‐term evaluation.；Second, the single‐arm design lacked a matched untreated control.；Third, sparse clinical response events at Month 3 and in the moderate‐to‐severe AD subgroup reduced the statistical precision of multivariable analyses.
对本项目的价值
★★★★☆ 脑老化是最大未满足需求，也是终点最难量化的领域；biomarker 与认知读数选择最敏感。顶刊证据；最大样本量约 181；设计 系统综述、问卷。
全文来源
PMC JATS 全文（正文 31,520 字符，已过标题/DOI 逐字归属校验）
原文题录
- 英文标题：Real-world clinical, biomarker, and imaging outcomes of lecanemab in Alzheimer's disease: a multicenter longitudinal cohort study in Jiangsu, China.
- 期刊与标识：Alzheimers Dement · PMID 42934846 · DOI 10.1002/alz.71936**
A 级证据分级：A 级（同行评议人体研究）
本文属人体研究证据，但需注意：观察性或小样本干预的结论不等于已证实临床获益；效应量与长期安全性仍需更大规模、更长随访的试验验证。
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