Disease modifying trials in Alzheimer disease: methodological and statistical issues

Andrieu, S.; Rascol, O.; Lang, T.; Grandjean, H.; Vellas, B.

Journal of Nutrition Health and Aging 10(2): 116-117

2006


ISSN/ISBN: 1279-7707
PMID: 16554944
Document Number: 596601
In order to establish that a drug has an impact on disease progression, a clinical trial must study both the symptomatic and the disease modifying effect of the drug. Disease modifying trials raise some methodological issues with regard to the choice of the design (parallel arm versus two-period design), of the outcome (clinical versus surrogate) and of the statistical analysis (management of missing data).

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