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IC‐P‐107: QUALITY ASSESSMENT OF RESTING‐STATE FUNCTIONAL MRI EXPERIMENTS IN CLINICAL TRIALS
Author(s) -
Marais Lea,
Lee Sarah,
Hill Derek,
McLeish Kate
Publication year - 2014
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2014.05.113
Subject(s) - siemens , clinical trial , resting state fmri , medical physics , neuroimaging , computer science , quality (philosophy) , medicine , psychology , nuclear medicine , pathology , radiology , psychiatry , physics , quantum mechanics , philosophy , epistemology
(pMut+, n1⁄432) with Clinical Dementia Rating (CDR) scale global score of 0, and symptomatic mutation carriers (sMut+, n1⁄441) with CDR>0. Whole brain, ventricle, and hippocampal regions were delineated from each image, and measures of atrophy were calculated over these regions using the groupwise Boundary Shift Integral (BSI). Results: Demographics and rates of change are shown in the Table. The sMut+ group had higher rates of atrophy than both NMC and pMut+. While no differences were observed between NMC and pMut+ groups, a significant (p1⁄40.049) positive correlation between brain atrophy and expected onset was observed (p1⁄40.049, see Figure). When using the trial eligible population, preliminary sample size point estimates of 748 (brain), 709 (ventricle), 1317 (left hippocampus), and 902 (right hippocampus) per arm are needed to detect a 25% change in atrophy over one year (corrected for ageing) with 95% significance and 80% power. Conclusions: Brain atrophy using longitudinal MR scans show changes in key regions of affected carriers compared to non-carriers. The inclusion criteria proposed for these trials appear to be sensible if using atrophy as one of the disease modification endpoints.