PREVENTABLE Biorepository and Laboratory

可预防的生物样本库和实验室

• 批准号: 10697308
• 负责人: Laura Kristin NEWBY
• 金额: $ 39.64万
• 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/10697308
• 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; Collaborations; 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; Longevity; Molecular; Outcome; Participant; Patients; Persons; Physical Function; Physiological; Policies; Polypharmacy; Positioning Attribute; Procedures; Process; Protocols documentation; Quality Control; Randomized; 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; randomized, clinical trials; 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.

生物库核心将使用马约诊所生物库中最先进的生物库操作，管理17，000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痴呆（包括阿尔茨海默病）和延长无残疾生存期的作用，在75岁及以上的患者没有临床明显的冠心病，包括那些虚弱，身体功能受损，轻度认知障碍，多药，和多发病。这些包括确认治疗功效和/或参与者对治疗的依从性（例如，他汀类药物预期的降脂水平），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点（例如，心血管疾病[CVD]和痴呆）。生物储藏核心将在马约和L. DCRI的克里斯汀纽比。马约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全民研究计划的中心生物储存库，并且具有独特的定位，可以作为可预防的生物储存库。我们将组建一个由衰老、老年科学、痴呆症（包括阿尔茨海默病）、虚弱和CVD生物标志物专家组成的团队，以支持使用库存生物标本进行研究的建议。生物储存库团队将利用集体经验协调收集、处理、储存、检索以用于辅助研究，并最终将生物标本库转移至BioLINCC。AIM 1.收集、处理、转移和储存随机化受试者的17，000份基线样本，实施生物储存政策和程序，与试验领导保持有效沟通，在研究结束时将生物标本转移至BioLINCC，并实施持续质量控制，以确保未来研究生物标本的完整性。AIM 2.支持方案规定的实验室检测。将通过脂质水平的变化评估研究药物依从性和生理效应。AIM 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，健康老龄化和虚弱的重要标志物。