Abdelazim Karim, Allam Ahmed A, Afifi Badreldin, Abdulazeem Hebatullah, Elbehiry Ahmed I
Department of Biotechnology, Institute of Graduate Studies and Research, Alexandria University, Alexandria, Egypt.
Department of Biology, Biotechnology Program, The American University in Cairo, New Cairo, Egypt.
Neurol Sci. 2024 Aug;45(8):3583-3597. doi: 10.1007/s10072-024-07477-w. Epub 2024 Apr 3.
Alzheimer's disease, prevalent in individuals aged 60 and above, constitutes most dementia cases and significantly impairs memory and cognitive functions. With global Alzheimer's cases projected to triple by 2050, there is a pressing need for effective interventions. Lecanemab, a monoclonal antibody targeting amyloid-beta plaques, shows promise in slowing Alzheimer's progression. Positive clinical trial results have instilled hope in patients, prompting ongoing research to advance understanding and intervention possibilities. To contribute to this knowledge base, we conducted a systematic review and meta-analysis, focusing on lecanemab's efficacy and safety at a dosage of 10 mg/kg. This comprehensive approach aimed to address gaps in the current literature, scrutinize research disparities, and guide future investigations. Applying strict inclusion/exclusion criteria, we assessed study details, participant information, and intervention specifics, using the Cochrane risk of bias tool for quality evaluation. Statistical analyses, conducted with R software, included risk ratios and mean differences, assessing heterogeneity and publication bias. The meta-analysis reveals a significant positive effect of lecanemab (10 mg/kg biweekly) on cognitive outcomes in Alzheimer's disease. Consistent reductions in ADCOMS, CDR-SB, and ADAS-cog14 scores across studies indicate drug efficacy with narrow confidence intervals and no significant heterogeneity. While TEAE shows no significant difference, heightened risks of ARIA-E and ARIA-H associated with lecanemab underscore the need for vigilant safety monitoring in clinical practice. Despite the drug efficacy, the study emphasizes a balanced assessment of benefits and potential risks associated with lecanemab, providing critical insights for clinicians evaluating its use in addressing cognitive impairment in individuals with Alzheimer's disease.
阿尔茨海默病在60岁及以上人群中普遍存在,构成了大多数痴呆病例,并严重损害记忆和认知功能。预计到2050年,全球阿尔茨海默病病例将增加两倍,因此迫切需要有效的干预措施。lecanemab是一种靶向β淀粉样蛋白斑块的单克隆抗体,在减缓阿尔茨海默病进展方面显示出前景。积极的临床试验结果给患者带来了希望,促使正在进行的研究以增进理解和干预可能性。为了丰富这一知识库,我们进行了一项系统评价和荟萃分析,重点关注lecanemab在10mg/kg剂量下的疗效和安全性。这种全面的方法旨在填补当前文献中的空白,审视研究差异,并指导未来的调查。我们应用严格的纳入/排除标准,使用Cochrane偏倚风险工具进行质量评估,评估研究细节、参与者信息和干预细节。使用R软件进行的统计分析包括风险比和均值差异,评估异质性和发表偏倚。荟萃分析显示,lecanemab(每两周10mg/kg)对阿尔茨海默病的认知结果有显著的积极影响。各研究中ADCOMS、CDR-SB和ADAS-cog14评分的持续降低表明药物疗效显著,置信区间狭窄,且无显著异质性。虽然治疗中出现的不良事件没有显著差异,但与lecanemab相关的ARIA-E和ARIA-H风险增加,突出了临床实践中进行警惕的安全监测的必要性。尽管该药物有效,但该研究强调对lecanemab相关的益处和潜在风险进行平衡评估,为临床医生评估其在治疗阿尔茨海默病患者认知障碍中的应用提供了关键见解。