NeuroActiva, Inc., San Jose, USA.
Adv Clin Exp Med. 2023 Oct;32(10):1085-1087. doi: 10.17219/acem/172673.
Recently, the U.S. Food and Drug Administration (FDA) approved 2 anti-amyloid monoclonal antibodies, aducanumab (June 7, 2021) and lecanemab (July 6, 2023), for the treatment of Alzheimer's disease (AD) patients, and will most likely also approve a 3rd one, donanemab, soon. While these antibodies have been shown to significantly reduce amyloid in the brain, there is little, if any, evidence that they provide clinically meaningful benefit for AD patients by slowing cognitive decline. I have said it before, and I say it again: the reported benefits of anti-amyloid antibodies observed in clinical trials are erroneous and based on misinterpretation of data and a trivial miscalculation. For example, Sims et al. (2023) reported in a phase III clinical trial that donanemab treatment of early symptomatic AD patients with amyloid and tau pathology provided 35% and 36% slowing of clinical progression and cognitive decline, respectively, as measured using the Integrated Alzheimer's Disease Rating Scale (iADRS) and Clinical Dementia Rating-Sum of Boxes (CDR-SB) psychometric tests. Here, in this editorial, I show that 2.5% and 9.6% would be better estimates for less cognitive impairment with donanemab treatment.
最近，美国食品和药物管理局 (FDA) 批准了 2 种抗淀粉样蛋白单克隆抗体，aducanumab（2021 年 6 月 7 日）和 lecanemab（2023 年 7 月 6 日），用于治疗阿尔茨海默病（AD）患者，并且很可能很快还会批准第 3 种，donanemab。虽然这些抗体已被证明可显著减少大脑中的淀粉样蛋白，但几乎没有证据表明它们通过减缓认知能力下降为 AD 患者提供了有临床意义的益处。我之前说过，现在再说一次：临床试验中报告的抗淀粉样蛋白抗体的益处是错误的，这是基于对数据的错误解释和微不足道的计算错误。例如， Sims 等人。（2023 年）在一项 III 期临床试验中报告说，donanemab 治疗早期有淀粉样蛋白和 tau 病理的有症状 AD 患者，分别使临床进展和认知能力下降的速度减慢了 35%和 36%，这是通过使用综合阿尔茨海默病评定量表（iADRS）和临床痴呆评定量表总和（CDR-SB）心理测量测试来衡量的。在这里，在这篇社论中，我表明，donanemab 治疗可使认知障碍减少 2.5%和 9.6%。
