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F4–02–03: The statistical development of endpoints for Alzheimer's disease clinical trials
Author(s) -
Raghavan Nandini
Publication year - 2013
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.2013.04.330
Subject(s) - clinical trial , disease , cognitive impairment , clinical endpoint , medicine , psychology , computer science
over time as part of the Alzheimer’s Disease Neuroimaging Initiative, on 125 individuals with AD, 316 individuals withMCI, and a subset (n1⁄4224) ofMCI subjects who were followed for 3 years. Results: For clinical trials in AD, ventricular volume (VV) and hippocampal volume (HV) require the fewest number of subjects per arm in a two-arm clinical trial designed to detect a 25% reduction in annual change (p<0.05; VV: n1⁄4107; HV: n1⁄4229). In MCI trials, VV and HC also require the fewest subjects (p<0.05; VV: n1⁄4220; HV: n1⁄4469). Ventricular volume (0.71) and fusiform cortical thickness (0.62) had larger effect sizes than the volume of the entorhinal cortex (0.12) for comparing MCI that progress to dementia to those that remain stable (p<0.05).Conclusions:We demonstrate an approach that can be adapted to many criteria of interest for simultaneously comparing large numbers of biomarkers with low computations effort. The main limitation is the requirement of a balanced design, with all biomarkers collected on every individual.