PREVENTABLE Biorepository and Laboratory

可预防的生物样本库和实验室

• 批准号: 10259720
• 负责人: Laura Kristin NEWBY
• 金额: $ 86.62万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10259720
• 关键词: Adverse effects; Aging; All of Us Research Program; Alzheimer' s Disease; Ancillary Study; Biological; Biological Markers; Biological Specimen Banks; Cardiovascular Diseases; Child Health; Clinic; Clinical; Cognitive; Collection; Communication; Communities; Coronary heart disease; Dementia; Development; Disease; Disease Progression; Elderly; Ensure; Evaluation; Event; Funding; Future; Geroscience; Goals; Health; Impaired cognition; Impairment; Infrastructure; International; Laboratories; Leadership; Libraries; Lipids; Logistics; Longevity; Molecular; Outcome; Participant; Patients; Persons; Physical Function; Physiological; Policies; Polypharmacy; Positioning Attribute; Procedures; Process; Protocols documentation; Quality Control; Randomized; Randomized Clinical Trials; Registries; Research; Research Personnel; Resources; Retrieval; Risk; Role; Sampling; Science; Specific qualifier value; Subgroup; Testing; Treatment Efficacy; United States National Institutes of Health; biobank; cardiovascular health; cardiovascular risk factor; cohort; design; disability; experience; follow-up; frailty; healthy aging; individualized medicine; inflammatory marker; insight; medication compliance; mild cognitive impairment; multiple chronic conditions; operation; precision medicine; prevent; programs; protocol development; randomized trial; treatment effect; working group

The Biorepository Core will manage collection, processing and storage of biospecimens from 17,000 PREVENTABLE participants using state-of-the-art biobanking operations in the Mayo Clinic Biorepository. Biospecimens provide a number of important operational and scientific opportunities to determine the role of a moderate-intensity statin in preventing dementia (including Alzheimer’s disease) and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. These include confirming treatment efficacy and/or participant compliance with therapy (e.g., expected levels of lipid lowering with statins) and defining subgroups that preferentially benefit, furthering the construct of precision medicine. The collection of biospecimens is also an opportunity for discovery science that may provide insights into disease mechanisms, identify new treatment targets, elucidate mechanistic intersections between diseases (e.g., cardiovascular disease [CVD] and dementia). The Biorepository Core will be under the leadership of Drs. Mine Cicek at Mayo and L. Kristin Newby at DCRI. The Mayo Clinic manages hundreds of active biorepositories, is the central biorepository for the NIH All of Us Research Program, and is uniquely positioned to function as the PREVENTABLE Biorepository. We will assemble a team of experts in aging, geroscience, dementia (including Alzheimer’s disease), frailty, and CVD biomarkers to support proposal development for studies using banked biospecimens as well. The Biorepository team will leverage collective experience to coordinate the collection, processing, storage, retrieval for use in ancillary studies, and eventual transfer of the biospecimen library to BioLINCC. AIM 1. Collect, process, transfer, and store 17,000 baseline samples in randomized participants, implement biorepository policies and procedures, maintain effective communications with trial leadership, facilitate transfer of biospecimens to BioLINCC at study close, and apply continuous quality control to ensure the integrity of the biospecimens for future studies. AIM 2. Support protocol-specified laboratory testing. Study drug adherence and physiologic effect will be assessed by changes in lipid levels. AIM 3. Collaborate in planning future biomarker studies to identify important markers of cardiovascular risk, cognitive decline, healthy aging, and frailty.

Biorepository Core将使用Mayo Clinic Biorepository中最先进的生物群体操作来管理17,000名可预防参与者的生物测量的收集，处理和存储。 Biospecimens提供了许多重要的操作和科学机会，以确定现代强度他汀类药物在预防痴呆症（包括阿尔茨海默氏病）中的作用，并在75岁及以上的患者中延长了无残疾的生存，而没有临床证据的冠心病，包括临床上的冠心病，包括弱势，身体障碍，轻度认知的障碍，轻度认知障碍，多型疗法和多人症状。这些包括确认治疗效率和/或参与遵守治疗的依从性（例如，汀类药物的脂质降低水平）和定义优先受益的亚组，从而增强了精密医学的构建。生物测量的收集也是发现科学的机会，可以提供有关疾病机制，确定新治疗靶标的，阐明疾病（例如心血管疾病[CVD]和痴呆症）之间的机械交叉点的见解。生物座席核心将在Drs的领导下。梅奥（Mayo）和克里斯汀·纽比（L. Kristin Newby）的Cicek矿山。 Mayo诊所管理着数百个活跃的生物局体，是美国国家航空航天局（NIH）所有研究计划的中心生物座席，并且具有独特的位置，可以作为可预防的生物座席。我们将组建一个衰老，geroscience，痴呆症（包括阿尔茨海默氏病），脆弱和CVD生物标志物的专家团队，以支持提案开发，用于使用银行的生物测量。 Biorepository团队将利用集体经验来协调收集，加工，存储，检索辅助研究，并最终将Bioscecimen库转移到Biolincc。 AIM 1。在随机参与者中收集，过程，转移和存储17,000个基线样本，实施生物座席策略和程序，与试验领导保持有效的沟通，促进生物测量在研究关闭时向Biolincc转移到Biolincc，并应用持续的质量控制，以确保生物测量的完整性用于未来的研究。目标2。支持协议指定的实验室测试。研究药物依从性和生理效应将通过脂质水平的变化来评估。目标3。在计划未来的生物标志物研究中进行合作，以确定心血管风险，认知能力下降，健康衰老和脆弱的重要标志。