We should not distinguish between symptomatic and disease-modifying treatments in Alzheimer's disease drug development
We should not distinguish between symptomatic and disease-modifying treatments in Alzheimer's disease drug development
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DOI：
10.1016/j.jalz.2007.10.010
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发表时间：
2008-01-01
影响因子：
14
通讯作者：
Doody, Rachelle S.
中科院分区：
文献类型：
--
作者：
Doody, Rachelle S.
在阿尔茨海默病治疗的讨论中，症状和疾病修饰这两个术语已经成为标准，但它们的使用几乎没有理由。目前上市的药物被认为是对症的，因为它们导致了某种程度的平均改善超过基线，因为人们普遍认为它们的机制是有限的，它们的作用是完全可逆的。目前的试验方法无法区分症状和疾病改善效果。此外，很可能许多试验将在试验或个人层面上证明这些影响的组合。推动这种区别的力量主要是社会的，而不是科学的。药物最好首先寻求抗痴呆的声明，最好是在常规治疗的背景下，在尽可能小和持续时间尽可能短的试验中。进一步的改进将通过证明抗痴呆症的益处有多重要和持久来实现。(c)2008年阿尔茨海默氏症协会。All rights reserved.
The terms symptomatic and disease-modifying have become standard in discussions of Alzheimer's disease therapeutics, yet there is little justification for their use. Currently marketed drugs are presumed to be symptomatic because they lead to some degree of mean improvement over baseline and because of the widespread belief that their mechanisms are limited and their effects are completely reversible. Current trial methodologies cannot distinguish between symptomatic and disease-modifying effects. Furthermore, it is highly likely that many trials will demonstrate a combination of such effects at the level of the trial or at the level of the individual. The forces that drive this distinction are largely social, as opposed to scientific. It would be preferable for drugs to first seek an antidementia claim, preferably on the background of conventional therapies when possible, in trials that are as small and as short in duration as possible. Further refinements would come by demonstration of how substantial and how enduring the antidementia benefits are. (c) 2008 The Alzheimer's Association. All rights reserved.