Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease

Derek L.G. Hill, Adam J. Schwarz, Maria Isaac, Luca Pani, Spiros Vamvakas, Robert Hemmings, Maria C. Carrillo, Peng Yu, Jia Sun, Laurel Beckett, Marina Boccardi, James Brewer, Martha Brumfield, Marc Cantillon, Patricia E. Cole, Nick Fox, Giovanni B. Frisoni, Clifford Jack, Thomas Kelleher, Feng LuoGerald Novak, Paul Maguire, Richard Meibach, Patricia Patterson, Lisa Bain, Cristina Sampaio, David Raunig, Holly Soares, Joyce Suhy, Huanli Wang, Robin Wolz, Diane Stephenson

Research output: Contribution to journalArticlepeer-review

53 Scopus citations

Abstract

Background Regulatory qualification of a biomarker for a defined context of use provides scientifically robust assurances to sponsors and regulators that accelerate appropriate adoption of biomarkers into drug development. Methods The Coalition Against Major Diseases submitted a dossier to the Scientific Advice Working Party of the European Medicines Agency requesting a qualification opinion on the use of hippocampal volume as a biomarker for enriching clinical trials in subjects with mild cognitive impairment, incorporating a scientific rationale, a literature review and a de novo analysis of Alzheimer's Disease Neuroimaging Initiative data. Results The literature review and de novo analysis were consistent with the proposed context of use, and the Committee for Medicinal Products for Human Use released an opinion in November 2011. Conclusions We summarize the scientific rationale and the data that supported the first qualification of an imaging biomarker by the European Medicines Agency.

Original languageEnglish (US)
Pages (from-to)421-429.e3
JournalAlzheimer's and Dementia
Volume10
Issue number4
DOIs
StatePublished - Jul 2014

Keywords

  • Alzheimer's Disease Neuroimaging Initiative
  • Alzheimer's disease
  • Hippocampal volume
  • Mild cognitive impairment

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Cellular and Molecular Neuroscience

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