Lecanemab treatment for Alzheimer's Disease of varying severities and associated plasma biomarkers monitoring: A multi-center real-world study in China

IF 11.1 1区医学 Q1 CLINICAL NEUROLOGY

Alzheimer's & Dementia Pub Date : 2025-10-10 DOI:10.1002/alz.70750

Sihui Chen, Ruwei Ou, Qianqian Wei, Chunyu Li, Wei Song, Bi Zhao, Jing Yang, Jiajia Fu, Yuanzheng Ma, Jiyong Liu, Xiangming Wang, Dengfu Fang, Tao Hu, Li Xiao, Shushan Zhang, Rui Huang, Xiaoyan Guo, Fei Feng, Xueping Chen, Huifang Shang

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Abstract

INTRODUCTION

We investigated real-world efficacy, safety, and plasma biomarker dynamics of Lecanemab in Chinese patients with Alzheimer's disease (AD).

METHODS

A multi-center prospective cohort study enrolled 68 AD patients. Cognitive scales and plasma biomarkers were assessed at baseline (V0), 2.5 months (V1), and 7 months (V2).

RESULTS

Alzheimer's Disease Assessment Scale-Cognitive Subscale 14-item version (ADAS-cog14) scores improved significantly at both follow-ups, and plasma p-tau181 consistently declined. Both p-tau181 and p-tau217 correlated with cognition and partially predicted treatment response (area under the curve [AUC] = 0.734 and 0.713). Mixed-effects modeling confirmed their dynamic association with ADAS-cog14 scores. Subgroup analyses indicated benefits across sex and apolipoprotein E4 status, while moderate-to-severe cases showed limited response. Lecanemab was well tolerated, with asymptomatic amyloid-related imaging abnormalities in 17.65% and mild infusion reactions in 5.88%.

DISCUSSION

These findings support the short-term efficacy and safety of Lecanemab in early AD and highlight plasma biomarkers as a treatment-responsive biomarker.

Highlights

Lecanemab improved cognitive function in Chinese patients with mild cognitive impairment due to Alzheimer's disease (AD-MCI) and mild AD over a short period.
Plasma p-tau181 and p-tau217 showed significant correlation with cognitive scores, and their baseline level could partially predict the efficacy of lecanemab.
Lecanemab showed a favorable safety profile with low, manageable rates of amyloid-related imaging abnormalities (ARIA) and infusion reactions.

Abstract Image

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来卡耐单抗治疗不同严重程度阿尔茨海默病及相关血浆生物标志物监测：中国多中心真实世界研究

我们研究了来卡耐单抗在中国阿尔茨海默病（AD）患者中的实际疗效、安全性和血浆生物标志物动态。方法一项多中心前瞻性队列研究纳入68例AD患者。在基线（V0）、2.5个月（V1）和7个月（V2）时评估认知量表和血浆生物标志物。结果阿尔茨海默病评估量表-认知亚量表14 -项目版本（ADAS - cog14）得分在两次随访中均显著提高，血浆p - tau181持续下降。p - tau181和p - tau217都与认知相关，并部分预测治疗反应（曲线下面积[AUC] = 0.734和0.713）。混合效应模型证实了它们与ADAS - cog14评分的动态关联。亚组分析表明，不同性别和载脂蛋白E4状态均有益处，而中度至重度患者的反应有限。Lecanemab耐受性良好，无症状淀粉样蛋白相关影像学异常占17.65%，轻度输注反应占5.88%。这些发现支持了莱卡耐单抗治疗早期AD的短期疗效和安全性，并强调血浆生物标志物是治疗反应性生物标志物。Lecanemab在短期内改善了中国阿尔茨海默病（AD - MCI）和轻度AD患者的认知功能。血浆p - tau181和p - tau217与认知评分有显著相关性，其基线水平可以部分预测莱卡耐单抗的疗效。Lecanemab显示出良好的安全性，具有低且可控的淀粉样蛋白相关成像异常（ARIA）和输液反应率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alzheimer's & Dementia 医学-临床神经学

CiteScore

14.50

自引率

5.00%

发文量

299

审稿时长

3 months

期刊介绍： Alzheimer's & Dementia is a peer-reviewed journal that aims to bridge knowledge gaps in dementia research by covering the entire spectrum, from basic science to clinical trials to social and behavioral investigations. It provides a platform for rapid communication of new findings and ideas, optimal translation of research into practical applications, increasing knowledge across diverse disciplines for early detection, diagnosis, and intervention, and identifying promising new research directions. In July 2008, Alzheimer's & Dementia was accepted for indexing by MEDLINE, recognizing its scientific merit and contribution to Alzheimer's research.