Core B: Clinical Core

摘要：临床核心 堪萨斯大学（KU）ADRC的临床核心的使命是刺激和支持临床和 脑老化和阿尔茨海默病及相关疾病（ADRD）的转化研究。临床核心 作为一个中心，为研究人员提供数据、生物样本、研究参与者和基础设施支持 播种和支持研究工作，包括横截面，纵向，和赞助商发起的 临床试验临床核心还有助于国家研究计划（NACC，NCRAD，ADNI等）。 临床核心保持纵向特征的临床队列，并已发展和演变 响应式研究基础设施，以支持制药商发起的多中心临床研究。的 纵向队列通过提供参与者、数据和生物样本来刺激和支持研究 调查人员。在上一个资助周期，我们支持了134项研究（来自82名研究者）， 特征参与者（43个项目），生物样本（35个项目），回顾性数据（21个项目）， 利用我们的支助基础设施提供研究支助（35个项目）。我们的支持基础设施包括 临床试验团队，运动试验团队和临床研究服务团队（心理测量，安全性， 和临床评级）通过P30支持和对研究人员赠款的工作人员和服务的收费资助。 在下一个资助周期，我们将继续保持纵向特征的临床队列 （n~400名积极跟踪参与者），以支持地方和国家研究（目标1）。队列参与者为 每年进行一次表征（CDR和认知测试），并将完成腰椎穿刺和脑部MRI（针对ATN 生物标志物）和基于神经血管和血液的代谢生物标志物概况，为血管（V） 和代谢（M）生物标志物开发。我们将继续提供死后组织给 神经病理学核心通过脑尸检计划。 我们还将继续支持对老龄化和痴呆症的广泛研究， 代谢在衰老和AD中的作用（目的2）。我们有完善的系统， 与研究者一起表征参与者、数据和生物标本（通过数据和生物标志物核心）。我们 基础设施加速了对新疾病机制的研究，包括大脑中能量代谢的作用 老化和AD。我们将继续发展我们的支持结构，以支持NIH，行业和研究人员- 启动了临床试验，使新化合物和创新非药物的实验室到床边测试成为可能。 药理学研究 临床核心是KUMC老龄化和ADRD研究不断变化的景观的核心。我们将 加强和扩大这一基础，为越来越多的调查人员提供工具， 他们需要资源来加速他们的工作，并鼓励在新的研究途径中继续创新。

ABSTRACT: CLINICAL CORE The mission of the University of Kansas (KU) ADRC's Clinical Core is to stimulate and support clinical and translational research in brain aging and Alzheimer's disease and related disorders (ADRD). The Clinical Core serves as a hub supporting investigators with data, biological samples, research participants, and infrastructure to seed and support research endeavors, including cross-sectional, longitudinal, and investigator-initiated clinical trials. The Clinical Core also contributes to national research initiatives (NACC, NCRAD, ADNI, etc.). The Clinical Core maintains a longitudinally characterized Clinical Cohort and has developed and evolved a responsive research infrastructure to support investigator-initiated and multi-site clinical studies. The longitudinal Cohort stimulates and supports research by making participants, data, and biospecimens available to investigators. In the last funding cycle, we supported 134 studies (from 82 investigators) with well- characterized participants (43 projects), biosamples (35 projects), retrospective data (21 projects), and research support drawing on our support infrastructure (35 projects). Our support infrastructure includes a Clinical Trial Team, an Exercise Trial Team, and a Clinical Research Services Team (psychometric, safety, and clinical ratings) funded through P30 support and chargebacks for staff and services on investigator grants. In the next funding cycle, we will continue to maintain the longitudinally characterized Clinical Cohort (n~400 actively followed participants) to support local and national studies (Aim 1). Cohort participants are characterized annually (CDR and cognitive testing) and will complete lumbar puncture and brain MRI (for ATN biomarkers) and a neurovascular and blood-based metabolic biomarker profile to set the stage for vascular (V) and metabolic (M) biomarker development. We will continue to provide postmortem tissue to the Neuropathology Core through the Brain Autopsy Program. We will also continue to support broad studies in aging and dementia and advance our understanding of the role of metabolism in aging and AD (Aim 2). We have well developed systems for sharing highly characterized participants, data, and biospecimens with investigators (via the Data and Biomarker Cores). Our infrastructure accelerates work on novel disease mechanisms including the role of energy metabolism in brain aging and AD. We will continue to evolve our support structures to support NIH, industry, and investigator- initiated clinical trials, enabling bench-to-bedside testing of novel compounds and innovative non- pharmacological studies. The Clinical Core is central to the changing landscape of aging and ADRD research at KUMC. We will strengthen and extend this foundation to provide an increasing number of investigators with the tools and resources they need to accelerate their work and encourage continued innovation in new avenues of research.