Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease

被引：14

作者：

Romero, Klaus ^{[1
]}

Conrado, Daniela ^{[1
]}

Burton, Jackson ^{[1
]}

Nicholas, Timothy ^{[2
]}

Sinha, Vikram ^{[3
]}

Macha, Sreeraj ^{[3
]}

Ahamadi, Malidi ^{[3
]}

Cedarbaum, Jesse ^{[4
]}

Seibyl, John ^{[5
]}

Marek, Kenneth ^{[5
]}

Basseches, Peter ^{[3
]}

Hill, Derek ^{[6
]}

Somer, Ed ^{[7
]}

Gallagher, Jill ^{[8
]}

Dexter, David T. ^{[8
]}

Roach, Arthur ^{[8
]}

Stephenson, Diane ^{[1
]}

机构：

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

[2] Pfizer, Groton, CT USA

[3] Merck, Whitehouse Stn, NJ USA

[4] Biogen, Cambridge, MA USA

[5] Mol Neuroimaging, New Haven, CT USA

[6] Panoram Digital Hlth, St Pierre De Chartreuse, France

[7] Gen Elect, Little Chalfont, England

[8] Parkinsons UK, London, England

来源：

CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2019年 / 12卷 / 03期

关键词：

D O I：

10.1111/cts.12619

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

The Critical Path for Parkinson's (CPP) Imaging Biomarker and Modeling and Simulation working groups aimed to achieve qualification opinion by the European Medicines Agency (EMA) Committee for Medical Products for Human Use (CHMP) for the use of baseline dopamine transporter neuroimaging for patient selection in early Parkinson's disease clinical trials. This paper describes the regulatory science strategy to achieve this goal. CPP is an international consortium of three Parkinson's charities and nine pharmaceutical partners, coordinated by the Critical Path Institute.

引用

页码：240 / 246

页数：7

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