医学
疾病
痴呆
临床试验
食品药品监督管理局
淀粉样蛋白(真菌学)
联盟
淀粉样β
不利影响
重症监护医学
病理
内科学
药理学
政治学
法学
作者
Taoran Li,Ying Han,None Pre-AD Alliance of China
摘要
Alzheimer’s disease (AD) is the most common cause of dementia and accounts for 60 – 80% of all such cases. For approximately 20 years, the research and development of new drugs for AD all ended in failure; however, aducanumab was recently granted accelerated approval by the US Food and Drug Administration. Aducanumab is a representative passive anti-β-amyloid (Aβ) immunotherapy and is the only approved drug that directly targets the pathological changes of AD; it can significantly reduce brain Aβ deposition, which is a hallmark of AD. During the clinical trials of amyloid-targeting monoclonal antibodies, represented by aducanumab, amyloid-related imaging abnormalities (ARIA) were the most common and important adverse reactions. Therefore, before the large-scale clinical application of amyloid-targeting monoclonal antibodies, clinicians and radiologists need to fully understand ARIA so that they can make more informed decisions. Considering the very uneven distribution of medical resources in China, we — on behalf of the “Pre-AD Alliance of China” — believe that it is necessary to write a consensus to elaborate on the mechanisms, risk factors, identification methods, and administration processes of ARIA.
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