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.
