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

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.