The NINDS Parkinson's disease biomarkers program.
The NINDS Parkinson's disease biomarkers program.
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Ninds帕金森氏病生物标志物计划。
DOI：
10.1002/mds.26438
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发表时间：
2016-06
期刊：
影响因子：
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通讯作者：
PDBP consortium
中科院分区：
文献类型：
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作者：
Rosenthal LS;Drake D;Alcalay RN;Babcock D;Bowman FD;Chen-Plotkin A;Dawson TM;Dewey RB Jr;German DC;Huang X;Landin B;McAuliffe M;Petyuk VA;Scherzer CR;Hillaire-Clarke CS;Sieber BA;Sutherland M;Tarn C;West A;Vaillancourt D;Zhang J;Gwinn K;PDBP consortium
帕金森病（PD）的神经保护仍然难以捉摸。生物标志物有望消除治疗发展的障碍。因此，国家神经疾病和中风研究所建立了帕金森病生物标志物计划，以促进发现用于II-III期临床试验的PD生物标志物。帕金森病生物标志物项目利用一种新的联盟设计，专注于开发用于PD诊断、进展和预后的临床和实验室生物标志物。创建了标准化操作程序和合并参考样品，以进行跨项目比较和批效应评估。基于网络的数据管理资源有助于在研究社区中快速共享数据和生物样本，以用于其他生物标志物项目。11个联合体项目正在进行中，其中7个项目正在招募参与者并获取生物样本。截至2014年10月，1082名参与者已入组（620名PD，101名其他原因的帕金森综合征，23名原发性震颤和338名对照），其中1040名至少有一份生物样本。共有6898份来自基线、6、12和18个月访视的生物样本：1006份DNA、1661份RNA、1419份全血、1382份血浆、1200份血清和230份脑脊液（CSF）。血浆、血清和CSF样本的质量控制分析表明，几乎所有样本都是高质量的（2812份样本中有24份超过可接受的血红蛋白水平）。通过广泛提供样本和数据，使用基于现有标准的严格操作程序，对生物标志物发现进行假设检验，并提供补充现有项目的资源，帕金森病生物标志物项目将加快PD生物标志物研究的步伐。
Neuroprotection for Parkinson Disease (PD) remains elusive. Biomarkers hold the promise of removing roadblocks to therapy development. The National Institute of Neurological Disorders and Stroke has therefore established the Parkinson’s Disease Biomarkers Program to promote discovery of PD biomarkers for use in phase II-III clinical trials. Utilizing a novel consortium design, the Parkinson’s Disease Biomarker Program is focused on the development of clinical and laboratory-based biomarkers for PD diagnosis, progression, and prognosis. Standardized operating procedures and pooled reference samples were created to allow cross-project comparisons and assessment of batch effects. A web-based Data Management Resource facilitates rapid sharing of data and biosamples across the research community for additional biomarker projects. Eleven consortium projects are ongoing, seven of which recruit participants and obtain biosamples. As of October 2014, 1082 participants have enrolled (620 PD, 101 with other causes of parkinsonism, 23 essential tremor, and 338 controls), 1040 of whom have at least one biosample. There are 6898 total biosamples from baseline, 6, 12, and 18-month visits: 1006 DNA, 1661 RNA, 1419 whole blood, 1382 plasma, 1200 serum, and 230 cerebrospinal fluid (CSF). Quality control analysis of plasma, serum, and CSF samples indicates almost all samples are high quality (24 of 2812 samples exceed acceptable hemoglobin levels). By making samples and data widely available, using stringent operating procedures based upon existing standards, hypothesis testing for biomarker discovery, and providing a resource which complements existing programs, the Parkinson’s Disease Biomarker Program will accelerate the pace of PD biomarker research.