Vellas Bruno, Coley Nicola, Andrieu Sandrine
Gerontopole, CHU Toulouse, Department of Geriatric Medicine, Toulouse, France.
J Alzheimers Dis. 2008 Oct;15(2):289-301. doi: 10.3233/jad-2008-15212.
Disease modifying trials are becoming increasingly common in the field of Alzheimer's disease (AD) as the search for a treatment able to slow the progression of this disease continues. In this paper, we briefly discuss the methodological considerations for disease modifying trials that were addressed during three recent international task force meetings involving specialists in the field of AD trials. Topics covered included study design, the identification of appropriate outcomes, the use of biomarkers, and the identification of suitable study populations. We also provide an update on recent disease modifying trials which have enabled us to gain experience in the use of biomarkers and have helped to define suitable outcomes, and consider how they can help us to shape future perspectives for disease modifying trials.
随着寻找能够减缓阿尔茨海默病（AD）进展的治疗方法的工作仍在继续，疾病修饰试验在AD领域正变得越来越普遍。在本文中，我们简要讨论了在最近三次涉及AD试验领域专家的国际特别工作组会议上所探讨的疾病修饰试验的方法学考量。涵盖的主题包括研究设计、合适结局的确定、生物标志物的使用以及合适研究人群的确定。我们还提供了近期疾病修饰试验的最新情况，这些试验使我们在生物标志物的使用方面积累了经验，并有助于确定合适的结局，同时考虑它们如何能够帮助我们塑造疾病修饰试验的未来前景。
