PREVENTABLE Biorepository and Laboratory

可预防的生物样本库和实验室

• 批准号: 10021553
• 负责人: Laura Kristin NEWBY
• 金额: $ 146.05万
• 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/10021553
• 关键词: Adverse effects; Aging; All of Us Research Program; Alzheimer' s Disease; Ancillary Study; Biological; Biological Markers; 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.

生物样本库核心将使用 Mayo Clinic 生物样本库中最先进的生物样本库操作来管理 17,000 名可预防参与者的生物样本的收集、处理和存储，为确定中度样本的作用提供了许多重要的操作和科学机会。强度他汀类药物可预防痴呆（包括阿尔茨海默氏病）并延长 75 岁及以上无临床明显冠心病患者（包括患有冠心病的患者）的无残疾生存期虚弱、身体功能受损、轻度认知障碍、多重用药和多重发病，包括确认治疗效果和/或参与者对治疗的依从性（例如，他汀类药物降低血脂的预期水平）以及定义优先受益的亚组，从而进一步构建。生物样本的收集也是发现科学的机会，可以提供对疾病机制的见解，确定新的治疗目标，阐明疾病（例如心血管疾病）之间的机制交叉点。生物储存库核心将由 Mayo 的 Mine Cicek 博士和 DCRI 的 L. Kristin Newby 博士领导，Mayo Clinic 管理着数百个活跃的生物储存库，是 NIH All of Us 研究的中央生物储存库。我们将组建一个由衰老、老年科学、痴呆（包括阿尔茨海默病）、虚弱、生物样本库团队将利用集体经验来协调辅助研究的收集、处理、存储和检索，并最终将生物样本库转移到 BioLINCC。收集、处理、转移和存储随机参与者的 17,000 个基线样本，实施生物样本库政策和程序，与试验领导保持有效沟通，促进生物样本的转移在研究结束时向 BioLINCC 提交，并应用持续的质量控制以确保未来研究的生物样本的完整性。支持方案指定的实验室测试。将通过脂质水平的变化来评估研究药物的依从性和生理效应。合作规划未来的生物标志物研究，以确定心血管风险、认知能力下降、健康老龄化和虚弱的重要标志物。