Department of Psychiatry and Psychotherapy, LMU Hospital, Ludwig-Maximilians-Universität Munich, Munich, Germany.
German Center for Neurodegenerative Diseases (DZNE) Munich, Munich, Germany.
Eur J Neurol. 2024 Feb;31(2):e16049. doi: 10.1111/ene.16049. Epub 2023 Sep 11.
Our aim is to review the most recent evidence on novel antibody therapies for Alzheimer's disease directed against amyloid-β. This is a joint statement of the European Association of Neurology and the European Psychiatric Association. After numerous unsuccessful endeavors to create a disease-modifying therapy for Alzheimer's disease, substantial and consistent evidence supporting the clinical effectiveness of monoclonal antibodies aimed at amyloid-β is finally emerging. The latest trials not only achieved their primary objective of slowing the progression of the disease over several months but also demonstrated positive secondary clinical outcomes and a decrease in amyloid-β levels as observed through positron emission tomography scans. Taken as a whole, these findings mark a significant breakthrough by substantiating that reducing amyloid-β yields tangible clinical benefits, beyond mere changes in biomarkers. Concurrently, the regular utilization of the new generation of drugs will determine whether statistical efficacy translates into clinically meaningful improvements. This may well signify the dawning of a new era in the development of drugs for Alzheimer's disease.
我们的目的是回顾最近针对阿尔茨海默病的新型抗体疗法的证据,这些疗法针对的是淀粉样蛋白-β。这是欧洲神经病学会和欧洲精神病学协会的联合声明。在多次试图创造一种治疗阿尔茨海默病的疾病修饰疗法失败后,针对淀粉样蛋白-β的单克隆抗体具有临床疗效的实质性和一致性证据终于出现了。最新的试验不仅达到了在几个月内减缓疾病进展的主要目标,而且还显示出积极的次要临床结果,以及通过正电子发射断层扫描观察到的淀粉样蛋白-β水平的降低。总的来说,这些发现标志着一个重大突破,证明了降低淀粉样蛋白-β水平除了生物标志物的变化之外,还能带来切实的临床益处。同时,新一代药物的常规使用将决定统计学疗效是否转化为临床意义上的改善。这很可能标志着阿尔茨海默病药物开发新时代的到来。