• J Nutr Health Aging · Mar 2006

    Disease modifying trials in Alzheimer disease: methodological and statistical issues.

    • S Andrieu, O Rascol, T Lang, H Grandjean, and B Vellas.
    • Unite INSERM 558, Service d'epidemiologie, CHU Toulouse, France.
    • J Nutr Health Aging. 2006 Mar 1; 10 (2): 116-7.

    AbstractIn 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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