Arroyo-Pacheco Nelson, Sarmiento-Blanco Shayury, Vergara-Cadavid Guillermo, Castro-Leones Maryarena, Contreras-Puentes Neyder
GINUMED, Medicine Program, Rafael Núñez University Corporation, Cartagena, Colombia.
GINUMED, Medicine Program, Rafael Núñez University Corporation, Cartagena, Colombia.
Ageing Res Rev. 2025 Feb;104:102620. doi: 10.1016/j.arr.2024.102620. Epub 2024 Dec 3.
Alzheimer's disease, a progressive neurodegenerative pathology, is characterized by the accumulation of Amyloid-β plaques in the brain. Lecanemab (BAN2401), a humanized IgG1 monoclonal antibody, binds with high affinity to Amyloid-β protofibrils. It is the first monoclonal antibody for Alzheimer's disease to receive full FDA approval. This systematic review, conducted meticulously, examines the current use and safety of Lecanemab in treating Alzheimer's disease. We screened literature from databases such as PubMed Central, PubMed (MedLine), ScienceDirect, Scopus, Web of Science, and Wolters Kluwer for randomized controlled trials testing Lecanemab for cognitive decline in patients with mild cognitive impairment due to Alzheimer's disease. Outcomes measured included CDR-SB, ADCOMS, ADAS-Cog, and Amyloid burden on PET in centiloids. Likewise, reports were analyzed for adverse events associated with ARIA-A and ARIA-H. Five papers were included in the systematic review and three in the meta-analysis. The meta-analysis showed that Lecanemab slowed the progression of cognitive impairment as measured by CDR-SB, ADCOMS, and ADASCog, and significantly reduced Amyloid burden on PET in centiloids. However, Lecanemab was associated with an increased risk of ARIA-E and ARIA-H. Lecanemab has demonstrated efficacy in slowing cognitive impairment progression in Alzheimer's disease as measured by ADCOMS, ADAS-Cog, and CDR-SB. However, it is associated with an increased risk of ARIA-E and ARIA-H, particularly in ApoE4 carriers.
阿尔茨海默病是一种进行性神经退行性病变，其特征是大脑中β淀粉样蛋白斑块的积累。仑卡奈单抗（BAN2401）是一种人源化IgG1单克隆抗体，与β淀粉样蛋白原纤维具有高亲和力结合。它是首个获得美国食品药品监督管理局全面批准用于治疗阿尔茨海默病的单克隆抗体。这项精心开展的系统评价考察了仑卡奈单抗治疗阿尔茨海默病的当前应用情况和安全性。我们从美国国立医学图书馆生物医学与健康期刊数据库、PubMed（医学索引数据库）、科学Direct、Scopus、科学网和威科集团等数据库中筛选文献，以查找针对因阿尔茨海默病导致轻度认知障碍患者使用仑卡奈单抗治疗认知功能下降的随机对照试验。测量的结局指标包括临床痴呆评定量表总和版（CDR-SB）、阿尔茨海默病综合评定量表（ADCOMS）、阿尔茨海默病评定量表认知部分（ADAS-Cog）以及以淀粉样蛋白当量表示的正电子发射断层扫描（PET）上的淀粉样蛋白负荷。同样，对与淀粉样蛋白相关成像异常-脑水肿（ARIA-A）和淀粉样蛋白相关成像异常-出血（ARIA-H）相关的不良事件报告进行了分析。系统评价纳入了5篇论文，荟萃分析纳入了3篇论文。荟萃分析表明，仑卡奈单抗减缓了以CDR-SB、ADCOMS和ADAS-Cog衡量的认知障碍进展，并显著降低了以淀粉样蛋白当量表示的PET上的淀粉样蛋白负荷。然而，仑卡奈单抗与ARIA-E和ARIA-H风险增加相关。根据ADCOMS、ADAS-Cog和CDR-SB测量，仑卡奈单抗已证明在减缓阿尔茨海默病认知障碍进展方面具有疗效。然而，它与ARIA-E和ARIA-H风险增加相关，尤其是在载脂蛋白E4（ApoE4）携带者中。
