Estimating sample sizes for predementia Alzheimer's trials based on the Alzheimer's Disease Neuroimaging Initiative

摘要: This study modeled predementia Alzheimer's disease clinical trials. Longitudinal data from cognitively normal (CN) and mild cognitive impairment (MCI) participants in the Disease Neuroimaging Initiative were used to calculate sample size requirements for trials using outcome measures, including Clinical Dementia Rating scale sum of boxes, Mini-Mental State Examination, Assessment Scale-cognitive subscale with without delayed recall, Rey Auditory Verbal Learning Task. We examined impact on sizes enrichment genetic biomarker criteria, cerebrospinal fluid protein neuroimaging analyses. observed little decline CN population at 36 months, regardless strategy. Nonetheless, subjects, Task total as an months required fewest subjects across strategies, apolipoprotein E genotype e4 carrier status requiring (n = 499 per arm demonstrate a 25% reduction progression). In MCI, reduced trials, relative estimates based all subjects. For boxes consistently smallest sizes. conclude that trial conduct is enhanced by use inclusion criteria.