期刊
ALZHEIMERS & DEMENTIA
卷 10, 期 4, 页码 421-429出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jalz.2013.07.003
关键词
Alzheimer's disease; Hippocampal volume; Mild cognitive impairment; Alzheimer's Disease Neuroimaging Initiative
资金
- US Food and Drug Association [U01FD003865]
- Science Foundation Arizona [SRG 0335-08]
- National Institute for Health Research [NF-SI-0513-10134, NF-SI-0508-10123] Funding Source: researchfish
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据