Donanemab早期阿尔茨海默氏症。

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Mintun马,Lo AC,达根埃文斯C,鞋号,Ardayfio PA,安徒生西南,Shcherbinin年代,火花J,西姆斯JR Brys M, Apostolova LG、Salloway SP, Skovronsky DM

Donanemab早期阿尔茨海默氏症。

郑传经地中海J。2021年3月13日。doi: 10.1056 / NEJMoa2100708。

PubMed ID

33720637 (在PubMed

]

文摘

背景:阿尔茨海默氏症的一个特征是β-淀粉样肽(β淀粉状蛋白质)的积累。Donanemab抗体,目标修改形式的β淀粉状蛋白质沉积,正在调查早期阿尔茨海默病的治疗。方法:我们进行了第二阶段试验donanemab患者早期阿尔茨海默病症状τ,淀粉样蛋白沉积在正电子发射断层扫描(PET)。病人被随机分配在一个1:1比例获得donanemab(前三个剂量700毫克和1400毫克之后)或安慰剂每4周静脉注射72周。主要结果是基线的改变综合阿尔茨海默病评定量表上的得分(iADRS;范围0到144,得分越低,表明更大的认知和功能障碍)在76周。次要结果包括分数的变化的临床痴呆评定Scale-Sum盒(CDR-SB),阿尔茨海默病的13项认知子量表评估量表(ADAS-Cog13),阿尔茨海默病合作Study-Instrumental日常生活活动量表(ADCS-iADL)和细微精神状态检查(MMSE),以及淀粉样蛋白的变化和τ负担的宠物。结果:共有257名患者被录取;131年被分配接受donanemab, 126年接受安慰剂。两组基线iADRS得分是106。 The change from baseline in the iADRS score at 76 weeks was -6.86 with donanemab and -10.06 with placebo (difference, 3.20; 95% confidence interval, 0.12 to 6.27; P = 0.04). The results for most secondary outcomes showed no substantial difference. At 76 weeks, the reductions in the amyloid plaque level and the global tau load were 85.06 centiloids and 0.01 greater, respectively, with donanemab than with placebo. Amyloid-related cerebral edema or effusions (mostly asymptomatic) occurred with donanemab. CONCLUSIONS: In patients with early Alzheimer's disease, donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed. Longer and larger trials are necessary to study the efficacy and safety of donanemab in Alzheimer's disease. (Funded by Eli Lilly; TRAILBLAZER-ALZ ClinicalTrials.gov number, NCT03367403.).

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Donanemab