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用于阿尔茨海默病预防试验的概念框架和伦理分析。

A conceptual framework and ethics analysis for prevention trials of Alzheimer Disease.

机构信息

Department of Psychology, Trent University, Peterborough, ON, Canada.

出版信息

Prog Neurobiol. 2013 Nov;110:114-23. doi: 10.1016/j.pneurobio.2012.12.001. Epub 2013 Jan 21.

DOI:10.1016/j.pneurobio.2012.12.001
PMID:23348495
Abstract

As our understanding of the neurobiology of Alzheimer Disease deepens, it has become evident that early intervention is critical to achieving successful therapeutic impact. The availability of diagnostic criteria for preclinical Alzheimer Disease adds momentum to research directed at this goal and even to prevention. The landscape of therapeutic research is thus poised to undergo a dramatic shift in the next 5-10 years, with clinical trials involving subjects at risk for Alzheimer Disease who have few or no symptoms. These trials will also likely rely heavily on genetics, biomarkers, and or risk factor stratification to identify individuals at risk for Alzheimer Disease. Here, we propose a conceptual framework to guide this next generation of pharmacological and non-pharmacological clinical pursuit, and discuss some of the foreseeable ethical considerations that may accompany them.

摘要

随着我们对阿尔茨海默病神经生物学的理解不断加深,早期干预对于实现成功的治疗效果至关重要,这一点已经变得很明显。用于临床前阿尔茨海默病的诊断标准的出现,为这一目标的研究甚至是预防工作增添了动力。因此,在未来 5-10 年内,治疗研究领域有望发生重大转变,涉及到有或没有症状的阿尔茨海默病风险人群的临床试验将大量出现。这些试验也可能严重依赖遗传学、生物标志物和/或风险因素分层,以确定有阿尔茨海默病风险的个体。在这里,我们提出了一个概念框架来指导下一代药理学和非药理学的临床追求,并讨论了一些可能伴随而来的可预见的伦理考虑因素。

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