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 A 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 journalArticle

43 Citations (Scopus)

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
Number of pages9
JournalAlzheimer's and Dementia
Volume10
Issue number4
DOIs
StatePublished - 2014

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Alzheimer Disease
Biomarkers
Medicine
Clinical Trials
Neuroimaging
Pharmaceutical Preparations

Keywords

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

ASJC Scopus subject areas

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

Cite this

Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease. / Hill, Derek L G; Schwarz, Adam J.; Isaac, Maria; Pani, Luca; Vamvakas, Spiros; Hemmings, Robert; Carrillo, Maria C.; Yu, Peng; Sun, Jia; Beckett, Laurel A; Boccardi, Marina; Brewer, James; Brumfield, Martha; Cantillon, Marc; Cole, Patricia E.; Fox, Nick; Frisoni, Giovanni B.; Jack, Clifford; Kelleher, Thomas; Luo, Feng; Novak, Gerald; Maguire, Paul; Meibach, Richard; Patterson, Patricia; Bain, Lisa; Sampaio, Cristina; Raunig, David; Soares, Holly; Suhy, Joyce; Wang, Huanli; Wolz, Robin; Stephenson, Diane.

In: Alzheimer's and Dementia, Vol. 10, No. 4, 2014, p. 421-429.

Research output: Contribution to journalArticle

Hill, DLG, Schwarz, AJ, Isaac, M, Pani, L, Vamvakas, S, Hemmings, R, Carrillo, MC, Yu, P, Sun, J, Beckett, LA, 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 2014, 'Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease', Alzheimer's and Dementia, vol. 10, no. 4, pp. 421-429. https://doi.org/10.1016/j.jalz.2013.07.003
Hill, Derek L G ; Schwarz, Adam J. ; Isaac, Maria ; Pani, Luca ; Vamvakas, Spiros ; Hemmings, Robert ; Carrillo, Maria C. ; Yu, Peng ; Sun, Jia ; Beckett, Laurel A ; Boccardi, Marina ; Brewer, James ; Brumfield, Martha ; Cantillon, Marc ; Cole, Patricia E. ; Fox, Nick ; Frisoni, Giovanni B. ; Jack, Clifford ; Kelleher, Thomas ; Luo, Feng ; Novak, Gerald ; Maguire, Paul ; Meibach, Richard ; Patterson, Patricia ; Bain, Lisa ; Sampaio, Cristina ; Raunig, David ; Soares, Holly ; Suhy, Joyce ; Wang, Huanli ; Wolz, Robin ; Stephenson, Diane. / Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease. In: Alzheimer's and Dementia. 2014 ; Vol. 10, No. 4. pp. 421-429.
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AU - Pani, Luca

AU - Vamvakas, Spiros

AU - Hemmings, Robert

AU - Carrillo, Maria C.

AU - Yu, Peng

AU - Sun, Jia

AU - Beckett, Laurel A

AU - Boccardi, Marina

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AU - Brumfield, Martha

AU - Cantillon, Marc

AU - Cole, Patricia E.

AU - Fox, Nick

AU - Frisoni, Giovanni B.

AU - Jack, Clifford

AU - Kelleher, Thomas

AU - Luo, Feng

AU - Novak, Gerald

AU - Maguire, Paul

AU - Meibach, Richard

AU - Patterson, Patricia

AU - Bain, Lisa

AU - Sampaio, Cristina

AU - Raunig, David

AU - Soares, Holly

AU - Suhy, Joyce

AU - Wang, Huanli

AU - Wolz, Robin

AU - Stephenson, Diane

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AB - 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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