Abstract
Background: Aim of this study was to compare the performance and power of the best-established diagnostic biological markers as outcome measures for clinical trials in patients with mild cognitive impairment (MCI).
Methods: Magnetic resonance imaging, F-18 fluorodeoxyglucose positron emission tomography markers, and Alzheimer’s Disease Assessment Scale-cognitive subscale were compared in terms of effect size and statistical power over different follow-up periods in 2 MCI groups, selected from Alzheimer’s Disease Neuroimaging Initiative data set based on cerebrospinal fluid (abnormal cerebrospinal fluid Ab1-42 concentration—ABETA +) or magnetic resonance imaging evidence of Alzheimer disease (positivity to hippocampal atrophy—HIPPO +). Biomarkers progression was modeled through mixed effect models. Scaled slope was chosen as measure of effect size. Biomarkers power was estimated using simulation algorithms.
Results: Seventy-four ABETA + and 51 HIPPO + MCI patients were included in the study. Imaging biomarkers of neuro-degeneration, especially MR measurements, showed highest performance. For all biomarkers and both MCI groups, power increased with increasing follow-up time, irrespective of biomarker assessment frequency.
Conclusion: These findings provide information about biomarker enrichment and outcome measurements that could be employed to reduce MCI patient samples and treatment duration in future clinical trials.
Original language | English |
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Pages (from-to) | 101-109 |
Number of pages | 9 |
Journal | Alzheimer Disease and Associated Disorders |
Volume | 29 |
Issue number | 2 |
Early online date | Dec 2014 |
DOIs | |
Publication status | Published - 1 Apr 2015 |