Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

I. J. Van Den Elskamp, B. Boden, V. Dattola, D. L. Knol, M. Filippi, L. Kappos, F. Fazekas, K. Wagner, C. Pohl, R. Sandbrink, C. H. Polman, B. M J Uitdehaag, F. Barkhof

Research output: Contribution to journalArticle

Abstract

Introduction: Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. Methods: One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. Results: A significant atrophy occurred over 6 months (PBVC∈=∈-0.33%, SE∈=∈0.061, p∈

Original languageEnglish
Pages (from-to)875-881
Number of pages7
JournalNeuroradiology
Volume52
Issue number10
DOIs
Publication statusPublished - Oct 2010

Keywords

  • Cerebral atrophy
  • Multiple sclerosis
  • Sample size
  • SIENA

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine

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    Van Den Elskamp, I. J., Boden, B., Dattola, V., Knol, D. L., Filippi, M., Kappos, L., Fazekas, F., Wagner, K., Pohl, C., Sandbrink, R., Polman, C. H., Uitdehaag, B. M. J., & Barkhof, F. (2010). Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis. Neuroradiology, 52(10), 875-881. https://doi.org/10.1007/s00234-009-0645-1