Core B: Clinical Core

核心 B：临床核心

• 批准号: 10264624
• 负责人: JEFFREY Murray BURNS
• 金额: $ 89.48万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10264624
• 关键词: Aging; Alzheimer' s Disease; Area; Autopsy; Bedside Testings; Biological; Biological Markers; Blood; Blood Vessels; Brain; Caregiver research; Cessation of life; Clinical; Clinical Data; Clinical Research; Clinical Trials; Complex; Consent; Consultations; Data; Dementia; Disease; Energy Metabolism; Environment; Exercise; Foundations; Funding; Grant; Growth; Human; Industry; Infrastructure; Kansas; Longitudinal cohort; MRI Scans; Magnetic Resonance Imaging; Measures; Metabolic; Metabolism; Mission; Multi-site clinical study; Participant; Positron-Emission Tomography; Psychometrics; Publications; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Role; Safety; Sampling; Seeds; Services; Specimen; Speed; Spinal Puncture; Structure; System; Time; Tissues; Translational Research; United States National Institutes of Health; Universities; Work; aging brain; base; bench to bedside; biomarker development; brain tissue; cognitive testing; cohort; design; drug development; innovation; multi-site trial; neuroimaging; neuropathology; neurovascular; new growth; novel; novel strategies; novel therapeutics; programs; ranpirnase; therapeutic evaluation; tool

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.

摘要：临床核心 堪萨斯大学 (KU) ADRC 临床核心的使命是刺激和支持临床和 脑衰老和阿尔茨海默病及相关疾病（ADRD）的转化研究。临床核心 充当为研究人员提供数据、生物样本、研究参与者和基础设施的支持中心 种子和支持研究工作，包括横断面、纵向和研究者发起的研究工作 临床试验。临床核心还为国家研究计划（NACC、NCRAD、ADNI 等）做出贡献。 临床核心维持一个纵向特征的临床队列，并不断发展和演变 响应式研究基础设施，支持研究者发起的多地点临床研究。这 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 给调查人员。在上一个资助周期中，我们支持了 134 项研究（来自 82 名研究人员）， 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）和 利用我们的支持基础设施（35 个项目）提供研究支持。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、 和临床评级）通过 P30 支持以及对研究人员补助金的工作人员和服务退款提供资金。 在下一个资助周期中，我们将继续维持纵向特征的临床队列 （n~400 名积极关注的参与者）支持地方和国家研究（目标 1）。队列参与者是 每年进行一次特征分析（CDR 和认知测试），并将完成腰椎穿刺和脑 MRI（用于 ATN 生物标志物）以及神经血管和血液代谢生物标志物概况，为血管（V）奠定基础 和代谢（M）生物标志物的开发。我们将继续向死者提供尸检组织 通过脑尸检计划的神经病理学核心。 我们还将继续支持衰老和痴呆症的广泛研究，并增进我们对衰老和痴呆症的理解 新陈代谢在衰老和 AD 中的作用（目标 2）。我们拥有完善的系统来高度共享 与研究人员一起描述参与者、数据和生物样本的特征（通过数据和生物标记核心）。我们的 基础设施加速了新疾病机制的研究，包括能量代谢在大脑中的作用 衰老和AD。我们将继续发展我们的支持结构，以支持 NIH、行业和研究者—— 启动了临床试验，实现了新型化合物和创新非药物的实验室到临床测试 药理学研究。 临床核心是 KUMC 不断变化的老龄化和 ADRD 研究的核心。我们将 加强和扩展这一基础，为越来越多的调查人员提供工具和 他们需要资源来加速他们的工作并鼓励新研究领域的持续创新。