The U.S. Food and Drug Administration (FDA) the second-ever drug in a new class of medications designed to treat Alzheimer''s disease. The drug — lecanemab (brand name Leqembi) — underwent "accelerated approval," which differs from the FDA''s standard approval process where drugmakers have to provide direct evidence of a drug''s clinical benefit. That said, late-stage trials do suggest that lecanemab slightly slows the rate of cognitive decline when taken in early stages of the disease. Although sometimes heralded as a "breakthrough" in news, lecanemab has garnered a mixed review from doctors and scientists because of its modest effectiveness and potential side effects, as well as its price tag. Live Science asked experts what they think about lecanemab and what patients should know about the treatment.
蛋白质“β-淀粉样蛋白”被认为是阿尔茨海默症致病原因之一。卫材开发的仑卡奈单抗则是以这一蛋白质为目标的疾病修饰治疗药物。如果脑部的β-淀粉样蛋白不断沉积，虽然最初不会产生恶性作用，但之后会导致神经细胞逐渐死亡，造成称为“海马体”的脑部重要区域衰退。该药正是基于2000年前后提出的这一学说实施开发。
药物开发的起点是瑞典乌普萨拉大学（Uppsala University）的一项研究成果。该大学调查了生活在北极圈的患有家族性阿尔茨海默症的人，发现了对治疗该病起到关键作用的可溶性β-淀粉样蛋白斑块。如果以此为目标制作出抗体，或许会成为划时代的药物。于是，乌普萨拉大学创办了总部设在斯德哥尔摩的新药开发初创企业。看中其研究潜力和前景的卫材于2005年和该企业建立了合作关系，之后主导推进了实用化研究。2014年，美国渤健（Biogen）也开始参与相关研究。 疾病修饰治疗药物的目的是以疑难杂症较多的自身免疫性疾病和神经退行性疾病为对象，预防发病和遏制病情发展。临床试验的构成方法等战略的优劣左右着开发的成败。据说高达1000亿日元乃至2000亿日元的开发成本大部分都花费在临床试验上。这对制药公司的实力也形成考验。
每两周注射1次，连续18个月注射每公斤体重10毫克的高剂量。最终阶段的临床试验采用了这样的频度和剂量。当初被认为与安慰剂相比，只要使阿尔茨海默症的症状恶化速度减缓20％就算合格，而临床试验结果显示该药具有可使病情减缓27％的效果。2022年年末，相关论文刊登在了全球最有权威的临床医学杂志上。
the second-ever drug in a new class of medications designed to treat Alzheimer''s disease. The drug — lecanemab (brand name Leqembi) — underwent "accelerated approval," which differs from the FDA''s standard approval process where drugmakers have to provide direct evidence of a drug''s clinical benefit. That said, late-stage trials do suggest that lecanemab slightly slows the rate of cognitive decline when taken in early stages of the disease. Although sometimes heralded as a "breakthrough" in news, lecanemab has garnered a mixed review from doctors and scientists because of its modest effectiveness and potential side effects, as well as its price tag. Live Science asked experts what they think about lecanemab and what patients should know about the treatment.
好的，我又可以多活几年了。快活的不耐烦了。
我上星期刚刷到华大的视频说现在研究艾滋海默症有了新的方向，可能过去的方向是错的。这会儿就出药了啊？这文章肯定骗人的。现在公众号都是标题党，骗人太容易了。
关键词：恶化速度减缓27%。打个比方，原来平均7.8个月就能达到的恶化指数，现在用上药需要10个月才能达到。
能延缓寿命一个月的化疗药FDA都批，凭什么不批这个药？
可溶性β-淀粉样蛋白斑块已经是老方向了。我以为已经被证实没用了呢。现在的方向是抗炎
脑出血死亡据说是巨痛持续然后死掉的
对，我刷到的视频就是这么说的，之前的方向不知道是不是错的，现在在研究新的方向
这个是不是基于前一段时间阿兹海默造假论文做的研发？