Power Calculations for Clinical Trials in Alzheimer's Disease

作者: M. Colin Ard , Steven D. Edland

DOI: 10.3233/JAD-2011-0062

关键词:

摘要: The Alzheimer research community is actively pursuing novel biomarker and other biologic measures to characterize disease progression or use as outcome in clinical trials. One product of these efforts has been a large literature reporting power calculations estimates sample size for planning future trials cohort studies with longitudinal rate change measures. Sample reported this vary greatly depending on variety factors, including the statistical methods model assumptions used their calculation. We review suggest standards calculation results. Regardless used, consistently find that volumetric neuroimaging regions interest, such hippocampal volume, outperform global cognitive scales traditionally treatment terms number subjects required detect fixed percentage slowing observed demented cognitively impaired populations. However, methods, assumptions, parameter are often not sufficient detail be maximum utility. factors influence estimates, discuss outstanding issues relevant Alzheimer's disease.

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