PREVENTABLE Biorepository and Laboratory

生物库核心将使用梅奥诊所生物库中最先进的生物库操作，管理来自17000名可预防参与者的生物标本的收集、处理和储存。生物标本提供了许多重要的操作和科学机会，以确定中等强度他汀类药物在预防老年痴呆症（包括阿尔茨海默病）和延长75岁及以上无临床明显冠心病患者（包括虚弱、身体功能受损、轻度认知障碍、多种药物和多种疾病患者）无残疾生存期中的作用。这些包括确认治疗效果和/或参与者对治疗的依从性（例如，使用他汀类药物降低血脂的预期水平），并确定优先受益的亚组，进一步构建精准医学。生物标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，确定新的治疗靶点，阐明疾病之间的机制交叉（例如，心血管疾病[CVD]和痴呆症）。生物储存库核心将由。我是梅奥的西塞克，我是DCRI的克里斯汀·纽比。梅奥诊所管理着数百个活跃的生物储存库，是美国国立卫生研究院“我们所有人”研究计划的中心生物储存库，并且具有独特的可预防生物储存库功能。我们将组建一个由衰老、老年科学、痴呆（包括阿尔茨海默病）、虚弱和心血管疾病生物标志物方面的专家组成的团队，以支持使用生物标本进行研究的提案制定。生物库团队将利用集体经验来协调用于辅助研究的收集、处理、存储、检索，并最终将生物标本库转移到BioLINCC。目的1。收集、处理、转移和储存随机参与者的17000份基线样本，实施生物库政策和程序，与试验领导保持有效沟通，在研究结束时促进生物标本转移到BioLINCC，并实施持续的质量控制，以确保生物标本的完整性，以供未来研究使用。目标2。支持协议指定的实验室测试。研究药物的依从性和生理效应将通过血脂水平的变化来评估。目标3。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、健康衰老和虚弱的重要标志物。

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.