Abstract
were used to estimate the number of mild pAD and aMCI patients needed per group to detect disease-modifying treatment effects in sixor twelve-month multi-center RCTs with 80% power and P 0.001 uncorrected for multiple comparisons. Results: The pAD patients had twelve-month CMRgl declines in posterior cingulate, precuneus, parietal, temporal and frontal regions and the aMCI patients had twelvemonth CMRgl declines in the posterior cingulate, precuneus, parietal and temporal regions. To detect a 20% treatment effect on posterior cingulate CMRgl declines, we estimate the need for 153 mild pAD patients per group and 728 aMCI patients per group in twelve-month RCTs. Conclusions: This study provides preliminary information about twelve-month CMRgl declines in mild pAD and aMCI patients and the number of patients needed to detect disease-modifying treatment effects in a twelve-month multi-center RCT. Future analyses will extend our findings to the entire ADNI cohort, provide power estimates for 6, 12, 18 and 24-month multi-center RCTs using specified search regions versus ROIs, and compare these power estimates to those using clinical ratings, other imaging modalities and other image-analysis techniques.
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