Biomarkers for Alzheimer's disease: academic, industry and regulatory perspectives

被引：480

作者：

Hampel, Harald ^{[1
]}

Frank, Richard ^{[2
]}

Broich, Karl ^{[3
]}

Teipel, Stefan J. ^{[4
,5
]}

Katz, Russell G. ^{[6
]}

Hardy, John ^{[7
,8
]}

Herholz, Karl ^{[9
]}

Bokde, Arun L. W. ^{[10
,11
]}

Jessen, Frank ^{[5
,12
]}

Hoessler, Yvonne C. ^{[13
]}

Sanhai, Wendy R. ^{[14
]}

Zetterberg, Henrik ^{[15
]}

Woodcock, Janet ^{[16
]}

Blennow, Kaj ^{[15
]}

机构：

[1] Goethe Univ Frankfurt, Dept Psychiat Psychosomat Med & Psychotherapy, D-60528 Frankfurt, Germany

[2] GE Healthcare, Global Med Affairs & Clin Strategy, Princeton, NJ 08540 USA

[3] Fed Inst Drugs & Med Devices BfArM, D-53175 Bonn, Germany

[4] Univ Rostock, Dept Psychiat, D-18147 Rostock, Germany

[5] German Ctr Neurodegenerat Disorders, DZNE, D-18147 Rostock, Germany

[6] US FDA, Div Neurol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[7] UCL, Inst Neurol, Dept Mol Neurosci, London WC1 3BG, England

[8] UCL, Inst Neurol, Reta Lila Weston Labs, London WC1 3BG, England

[9] Univ Manchester, Wolfson Mol Imaging Ctr, Manchester M20 3LJ, Lancs, England

[10] Natl Childrens Hosp, Adelaide & Meath Hosp Incorporating, Trin Ctr Hlth Sci, Trin Coll Dublin,Sch Med, Dublin 24, Ireland

[11] Natl Childrens Hosp, Adelaide & Meath Hosp Incorporating, Trin Ctr Hlth Sci, Trin Coll Dublin,Trinity Coll Inst Neurosci, Dublin 24, Ireland

[12] Univ Bonn, Dept Psychiat, D-53105 Bonn, Germany

[13] Univ Munich, Alzheimer Mem Ctr, Dept Psychiat, D-80336 Munich, Germany

[14] US FDA, Off Commissioner, Silver Spring, MD 20993 USA

[15] Univ Gothenburg, Sahlgrenska Acad, Inst Neurosci & Physiol, Dept Psychiat & Neurochem, S-43180 Motndal, Sweden

[16] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

NATURE REVIEWS DRUG DISCOVERY | 2010年 / 9卷 / 07期

基金：

爱尔兰科学基金会;

关键词：

MILD COGNITIVE IMPAIRMENT; POSITRON-EMISSION-TOMOGRAPHY; CEREBRAL GLUCOSE-METABOLISM; GAMMA-SECRETASE INHIBITOR; HUMAN CEREBROSPINAL-FLUID; LONGITUDINAL PET EVALUATION; AMYLOID PRECURSOR PROTEIN; BETA IMMUNIZATION AN1792; GENOME-WIDE ASSOCIATION; A-BETA;

D O I：

10.1038/nrd3115

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

Advances in therapeutic strategies for Alzheimer's disease that lead to even small delays in onset and progression of the condition would significantly reduce the global burden of the disease. To effectively test compounds for Alzheimer's disease and bring therapy to individuals as early as possible there is an urgent need for collaboration between academic institutions, industry and regulatory organizations for the establishment of standards and networks for the identification and qualification of biological marker candidates. Biomarkers are needed to monitor drug safety, to identify individuals who are most likely to respond to specific treatments, to stratify presymptomatic patients and to quantify the benefits of treatments. Biomarkers that achieve these characteristics should enable objective business decisions in portfolio management and facilitate regulatory approval of new therapies.

引用

页码：560 / 574

页数：15

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