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Publication Detail
Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Journal Article
  • Authors:
    Hill DLG, Schwarz AJ, Isaac M, Pani L, Vamvakas S, Hemmings R, Carrillo MC, Yu P, Sun J, Beckett L, Boccardi M, Brewer J, Brumfield M, Cantillon M, Cole PE, Fox N, Frisoni GB, Jack C, Kelleher T, Luo F, Novak G, Maguire P, Meibach R, Patterson P, Bain L, Sampaio C, Raunig D, Soares H, Suhy J, Wang H, Wolz R, Stephenson D
  • Publication date:
    07/2014
  • Pagination:
    421, 429.e3
  • Journal:
    Alzheimers Dement
  • Volume:
    10
  • Issue:
    4
  • Status:
    Published
  • Country:
    United States
  • PII:
    S1552-5260(13)02497-7
  • Language:
    eng
  • Keywords:
    Alzheimer's Disease Neuroimaging Initiative, Alzheimer's disease, Hippocampal volume, Mild cognitive impairment, Alzheimer Disease, Clinical Trials as Topic, Cognitive Dysfunction, Databases, Factual, Disease Progression, Europe, Hippocampus, Humans, Neuroimaging, Proportional Hazards Models, ROC Curve
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.
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Neurodegenerative Diseases
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