Real‐world clinical, biomarker, and imaging outcomes of lecanemab in Alzheimer's disease: a multicenter longitudinal cohort study in Jiangsu, China
Limoran Tang, Xicheng Chen, Li Zhang, Lin Fan, Nihong Chen, Chaosheng Li, Zenglin Cai, Guofang Chen, Haifeng Chen, Min Ye, Huifen Zheng, Qi Li, Zhihong Ke, Zheqi Hu, Maohong Cao, Dan Yang, Shuai Xu, Chunming Xie, Xiaobo Li, Xiaotian Xu, Ming Yu, Xuegan Lian, Hua Hu, Hongfei Li, Xiuying Cai, Hong Chen, Wu Xu, Guiyun Cui, Yang Zhao, Jingde Dong, Lili Zhang, Xiaolei Zhu, Hui Zhao, Yun XuAbstract
INTRODUCTION
Real‐world data on lecanemab's efficacy and the longitudinal dynamics of plasma biomarkers are scarce in Chinese patients with Alzheimer's disease (AD).
METHODS
In this multicenter cohort study, 181 AD patients received biweekly lecanemab. Disease‐stage‐specific Clinical Dementia Rating–Sum of Boxes meaningful within‐patient change defined response at Months 3, 6, and 12. We used penalized models, receiver operating characteristic analysis, attrition comparisons, and exploratory Month 3 plasma biomarker analysis.
RESULTS
Cognitive response emerged at Month 6 and intensified by Month 12, largely restricted to mild cognitive impairment and mild dementia due to AD. Repeated five‐fold cross‐validated areas under the curve across the follow‐up timepoints were 0.560, 0.747, and 0.773, with apolipoprotein E ε4 positivity and more severe cognitive impairment linked to lower response odds. Plasma phosphorylated tau 217 (p‐tau217) and amyloid beta (Aβ) 42/40 altered as early as Month 3. Month 3 Aβ42/40 showed modest exploratory discrimination. The incidence of amyloid‐related imaging abnormalities was 7.2%, all asymptomatic.
DISCUSSION
Lecanemab is effective and safe in AD over 6 to 12 months. Early biomarker changes (p‐tau217, Aβ42/40) precede clinical improvement, serving as scalable response indicators.