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

被引：69

作者：

Hill, Derek L. G. ^{[1
]}

Schwarz, Adam J. ^{[2
]}

Isaac, Maria ^{[3
]}

Pani, Luca ^{[3
]}

Vamvakas, Spiros ^{[3
]}

Hemmings, Robert ^{[3
]}

Carrillo, Maria C. ^{[4
]}

Yu, Peng ^{[2
]}

Sun, Jia ^{[2
,5
]}

Beckett, Laurel ^{[6
]}

Boccardi, Marina ^{[7
]}

Brewer, James ^{[8
]}

Brumfield, Martha ^{[9
]}

Cantillon, Marc ^{[10
]}

Cole, Patricia E. ^{[2
]}

Fox, Nick ^{[11
]}

Frisoni, Giovanni B. ^{[7
]}

Jack, Clifford ^{[12
]}

Kelleher, Thomas ^{[13
]}

Luo, Feng ^{[13
]}

Novak, Gerald ^{[14
]}

Maguire, Paul ^{[15
]}

Meibach, Richard ^{[16
]}

Patterson, Patricia ^{[17
]}

Bain, Lisa

Sampaio, Cristina ^{[18
]}

Raunig, David ^{[19
]}

Soares, Holly ^{[13
]}

Suhy, Joyce ^{[20
]}

Wang, Huanli ^{[6
]}

Wolz, Robin ^{[1
,21
]}

Stephenson, Diane ^{[9
]}

机构：

[1] IXICO Ltd, London, England

[2] Eli Lilly & Co, Indianapolis, IN 46285 USA

[3] European Med Agcy, London, England

[4] Alzheimers Assoc, Chicago, IL USA

[5] Univ Texas Houston, Sch Publ Hlth, Houston, TX USA

[6] Univ Calif Davis, Davis, CA 95616 USA

[7] IRCCS Fatebenefratelli, Brescia, Italy

[8] Univ Calif San Diego, San Diego, CA 92103 USA

[9] Crit Path Inst, Tucson, AZ 85718 USA

[10] Wellnessmanagments Com, Livingston, NJ USA

[11] UCL Inst Neurol, London, England

[12] Mayo Clin, Rochester, MN USA

[13] Bristol Myers Squibb Co, Wallingford, CT 06492 USA

[14] Janssen Pharmaceut Res & Dev, Titusville, NJ USA

[15] Novartis, Basel, Switzerland

[16] Novartis, E Hanover, NJ USA

[17] AstraZeneca, Wilmington, DE USA

[18] CHDI Fdn Inc, Princeton, NJ USA

[19] ICON Med Imaging, Warrington, PA USA

[20] SYNARC Inc, Newark, CA USA

[21] Univ London Imperial Coll Sci Technol & Med, Dept Comp, London, England

来源：

ALZHEIMERS & DEMENTIA | 2014年 / 10卷 / 04期

关键词：

Alzheimer's disease; Hippocampal volume; Mild cognitive impairment; Alzheimer's Disease Neuroimaging Initiative; MILD COGNITIVE IMPAIRMENT; ATROPHY RATES; NATIONAL INSTITUTE; MRI; CONVERSION; DIAGNOSIS; DEMENTIA; AD; PROGRESSION; PREDICTION;

D O I：

10.1016/j.jalz.2013.07.003

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

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. (C) 2014 The Alzheimer's Association. All rights reserved.

引用

页码：421 / 429

页数：9

共 48 条

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