Clinical Core

临床核心

• 批准号: 10035018
• 负责人: DAVID S GELDMACHER
• 金额: $ 58.61万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10035018
• 关键词: Address; Affect; African American; Alzheimer' s Disease; Alzheimer' s disease related dementia; Amyloid; Autopsy; Biological; Biological Markers; Blinded; Blood; Blood Vessels; Blood specimen; Brain; Categories; Classification; Clinic; Clinical; Clinical Data; Clinical Investigator; Clinical Sciences; Clinical assessments; Cognition; Cognitive; Collaborations; Collection; Community Outreach; Consensus; Consent; County; DNA; Data; Data Collection; Data Set; Databases; Deep South; Dementia; Development; Diagnosis; Enrollment; Evaluation; Fostering; Functional Magnetic Resonance Imaging; Future; Gap Junctions; Genetic; Genomic medicine; Genotype; Goals; Image; Impaired cognition; Individual; Life; Life Cycle Stages; Liquid substance; Logistics; Measures; Medical; Metabolic; Methods; Molecular; Molecular Structure; Monitor; Outcome; Participant; Pathology; Peripheral Blood Mononuclear Cell; Phase; Plasma; Population; Positron-Emission Tomography; Process; Protocols documentation; Publishing; RNA; Research; Risk; Risk Factors; Rural Community; Sampling; Serum; Site; Structure; Testing; Translational Research; Transportation; Trust; Urine; Work; ancestry analysis; base; blood product; clinical biomarkers; clinical center; clinical diagnostics; cohort; data management; data quality; data sharing; design; end of life; functional status; genetic risk factor; genomic data; health disparity; imaging facilities; imaging study; mild cognitive impairment; multidisciplinary; neuroimaging; neuropathology; programs; research clinical testing; social health determinants; stressor; symposium; tau Proteins; vascular risk factor

PROJECT SUMMARY/ABSTRACT The Clinical Core (CC) will enroll participants in a carefully considered cohort to with a primary goal in the P20 phase of demonstrating the feasibility of collecting the proposed dataset from a cohort with substantial representation of groups disparately affected by Alzheimer’s disease and related dementias (ADRD) in the Deep South, and establishing the capacity to perform all critical Clinical Core functions. Projected enrollment will include 50 new participants annually for 3 years. The cohort will include cognitively unimpaired (~50%), MCI (~30%) and mild dementia (~20%). Black or African American (B/AA) participants will be over- represented in the cohort, working closely with the Community Outreach, Diversity, and Inclusion Core. The Core will collect the uniform dataset, several other cognitive and functional measures, and evaluation of social determinants of health and vascular risks. Fluid biomarkers including blood and urine will be collected from all participants, with CSF optional but encouraged. Genotyping from blood samples will be conducted with colleagues in the UAB-HudsonAlpha Center for Genomic Medicine and shared via NIAGADS. CSF, blood products, and urine will be banked for local access and shared via NCRAD. A subset of participants will receive neuroimaging, which includes structural and functional MRI, [11C]PiB amyloid PET, and [18F]flortaucipir Tau PET. A multidisciplinary Clinical Consensus Conference will determine diagnostic clinical classifications. A separate Biomarker Consensus Conference will classify individuals to A/T/N categories while blinded to the clinical data and classification. Data from sequential clinical assessments will be collected and submitted to NACC per UDS protocols. Well-characterized participants will be referred to clinical investigators approved via the ADRC’s Data Sharing and Protocol Review process. Pre-mortem autopsy coordination and consent, as well as longitudinal assessment data will be collected on behalf of the brain donation program.

项目摘要/摘要 临床核心（CC）将招募参与者参加经过精心考虑的队列，该队列的主要目标是 P20阶段证明从具有实质性的队列中收集所提出的数据集的可行性 在阿尔茨海默氏病和相关痴呆症（ADRD）中不同影响的群体的代表 深南部，并确定执行所有关键临床核心功能的能力。预计的入学人数 每年将包括50名新参与者3年。该队列将包括认知单翼（〜50％）， MCI（〜30％）和轻度痴呆（约20％）。黑人或非裔美国人（B/AA）参与者将过度 在队列中代表，与社区外展，多样性和包容核心紧密合作。 核心将收集统一的数据集，其他几种认知和功能措施，并评估社会 健康和血管风险的决定因素。从所有人那里收集包括血液和尿液在内的流体生物标志物 参与者，有CSF的可选，但受到鼓励。从血液样本中进行基因分型将与 UAB-Hudsonalpha基因组医学中心的同事，并通过Niagads共享。 CSF，血液 产品和尿液将用于本地访问，并通过NCRAD共享。一部分参与者将 接收神经影像学，包括结构和功能性MRI，[11C] PIB淀粉样蛋白PET和[18F] Flortaucipir tau宠物。多学科的临床共识会议将确定诊断性临床分类。 一个单独的生物标志物共识会议将对个人分类为A/T/N类别，而对 临床数据和分类。将收集来自顺序临床评估的数据并提交给 NACC通过UDS协议。特征良好的参与者将转交给通过 ADRC的数据共享和协议审核过程。验尸前的协调和同意 纵向评估数据将代表大脑捐赠计划收集。