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For each percentage of <jats:italic>APOE<\/jats:italic> \u03b54 carriers, we resampled the database randomly for 1000 trials for each trial scenario, planning for 18\u2010 or 24\u2010month trials with samples from 50 to 400 patients per treatment or placebo group, up to 40% dropouts, and outcomes on the Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS\u2010cog) with effect sizes from 0.15 to 0.75, and calculated statistical power.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Enrichment of clinical trial participants based on <jats:italic>APOE<\/jats:italic> \u03b54 carrier status resulted in minimal increases in power compared with enrolling participants with the <jats:italic>APOE<\/jats:italic> \u03b53 genotype only or enrolling patients without regard to <jats:italic>APOE<\/jats:italic> genotype. Increased screening requirements to enhance the sample would offset gains in power.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Although samples enriched for <jats:italic>APOE<\/jats:italic> \u03b54 carriers in AD or MCI clinical trials showed slightly more cognitive impairment and greater decline using the number <jats:italic>APOE<\/jats:italic> \u03b54 alleles as an inclusion criterion most likely would not result in more efficient trials, and trials would take longer because fewer patients would be available. The <jats:italic>APOE<\/jats:italic> \u03b54\/\u03b5X (where X\u00a0=\u00a02, 3 or 4) genotype could be useful, however, as an explanatory variable or covariate if warranted by a drug's action.<\/jats:p><\/jats:sec>","DOI":"10.1016\/j.jalz.2013.03.003","type":"journal-article","created":{"date-parts":[[2013,5,25]],"date-time":"2013-05-25T00:01:59Z","timestamp":1369440119000},"page":"349-359","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Effect of <i>APOE<\/i> genotype status on targeted clinical trials outcomes and\u00a0efficiency in dementia and mild cognitive impairment resulting from\u00a0Alzheimer's disease"],"prefix":"10.1002","volume":"10","author":[{"given":"Richard E.","family":"Kennedy","sequence":"first","affiliation":[{"name":"University of Alabama, Birmingham Birmingham AL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary 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