Clinical Core

临床核心

• 批准号: 10628509
• 负责人: GABRIEL Alejandro DE ERAUSQUIN
• 金额: $ 249.05万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10628509
• 关键词: Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Argentina; Autopsy; Behavioral; Biological; Biological Markers; Blood; Brain; COVID-19; COVID-19 pandemic; COVID-19 point of care; Case Report Form; Charge; Chronic; Clinical; Clinical Data; Clinical assessments; Cognitive; Consensus; Consent; DNA; DNA purification; Data; Data Collection; Data Set; Databases; Dementia; Diagnosis; Diagnostic; Disease; Elderly; Enrollment; Ensure; Epidemiology; Etiology; Evaluation; Frontotemporal Dementia; Future; Genetic Variation; Goals; Image; Impaired cognition; Informed Consent; International; Interview; Language; Lewy Body Dementia; Magnetic Resonance Imaging; Medical; Methods; Mission; Neurologic; Neurologic Examination; Neuropsychology; Nigeria; Outcome; Participant; Pathologic; Periodicals; Persons; Plasma; Population; Positron-Emission Tomography; Procedures; Process; Protocols documentation; Recording of previous events; Recovery; Reporting; Research Project Grants; Risk; SARS-CoV-2 antibody; SARS-CoV-2 exposure; SARS-CoV-2 infection; Sampling; Schedule; Site; Specimen; Standardization; Structure; Syndrome; System; Tablets; Techniques; Testing; Texas; Time; Training; Vascular Dementia; Visit; Washington; Whole Blood; World Health Organization; behavioral neurology; biobank; clinical diagnostics; clinical research site; cohort; data acquisition; data collection site; data exchange; data management; experience; follow-up; genome sequencing; genomic variation; impression; informant; mild cognitive impairment; mixed dementia; neuroimaging; neuropathology; neuropsychiatric sequelae of COVID-19; neuropsychiatry; recruit; research clinical testing; statistics; symposium; whole genome

CC Summary Abstract The proposed Study on Interactions between SARS-CoV-2 infection and Ancestral genomic Variations in the Risk of Alzheimer's Disease (ISAVRAD) requires significant coordination across the five data collection sites (Argentina, Nigeria, and 3 sites in the US: Texas, NY, and Washington state) and 3 research projects. In support of the goals of ISAVRAD, the Clinical Core (CC) will enroll and conduct in-depth clinical evaluations of 4,300 older adults with (75% of the sample) and without (25% of the sample) exposure to SARS-CoV-2 at baseline, and will conduct follow-up evaluations at 18 and 36 months. Clinical evaluations will include medical and epidemiological histories focused on SARS- CoV-2 infection, including COVID-19 case report forms (CRFs) harmonized by the WHO, neuropsychological assessment (including Uniform Data Set and a tablet-based, language-independent assessment), neurological examination, and completion of the semi-structured interview Schedules for Clinical Assessment in Neuropsychiatry of the World Health Organization (WHO SCAN), as well as informant report. At all data collection time-points, the CC will also collect and ship blood biospecimens to carry out point-of-care COVID-19 antibody testing, extract DNA, and bank whole blood and plasma for future collaborative studies. It will also screen participants for MRI and harmonize MRI and PET data acquisition at all sites, sending imaging results to the Neuroimaging Core. The CC will also conduct case conferences to assign diagnostic clinical outcomes according to cognitive impairment level/ADRD status (unimpaired, Mild cognitive impairment, dementia syndrome with disease-specific etiologies). Disease specific etiologies will include AD, Lewy-Body Dementia, Vascular Dementia, Frontal Lobe Dementia, and mixed. Finally, the CC will employ a sophisticated data capture system, collaboratively developed with the Data Management and Statistics Core, to provide real- time data transmission to the ISAVRAD database via RedCAP. The CC will be co-lead by Dr. Gabriel A. de Erausquin Thomas Patterson, Dr. Sudha Seshadri, and Mindy Katz, MPH with the assistance of site PIs Rufus Akinyemi (Nigeria), Agustin Yecora (Argentina) and Malveeka Sharma (Seattle). In addition to already having a strong working relationship, they have decades of experience in data collection from diverse and understudied cohorts, longitudinal data collection, and recruitment of persons with dementia.

CC 摘要 拟议的 SARS-CoV-2 感染与祖先基因组变异之间相互作用的研究 阿尔茨海默病风险 (ISAVRAD) 需要五个数据收集站点之间的大力协调 （阿根廷、尼日利亚和美国 3 个地点：德克萨斯州、纽约州和华盛顿州）和 3 个研究项目。在 为了支持 ISAVRAD 的目标，临床核心 (CC) 将招募并进行深入的临床评估 4,300 名老年人（占样本的 75%）和未接触过 SARS-CoV-2（占样本的 25%） 基线，并将在 18 个月和 36 个月时进行后续评估。临床评估将包括医学评估 重点关注 SARS-CoV-2 感染的流行病学史，包括 COVID-19 病例报告表 (CRF) 由世界卫生组织协调的神经心理学评估（包括统一数据集和基于平板电脑的、 独立于语言的评估）、神经系统检查以及完成半结构化访谈 世界卫生组织神经精神病学临床评估时间表（WHO SCAN）以及 作为知情人报告。在所有数据收集时间点，CC 还将收集血液生物样本并将其运送至 进行即时 COVID-19 抗体检测、提取 DNA 并储存全血和血浆以供将来使用 合作研究。它还将对参与者进行 MRI 筛查，并协调 MRI 和 PET 数据采集 所有站点，将成像结果发送到神经成像核心。 CC还将召开案例会议 根据认知障碍水平/ADRD 状态分配诊断临床结果（未障碍、轻度 认知障碍、具有特定疾病病因的痴呆综合征）。疾病的具体病因将 包括AD、路易体痴呆、血管性痴呆、额叶痴呆和混合性痴呆。最后，CC将 采用与数据管理和数据管理部门合作开发的复杂数据采集系统 统计核心，通过RedCAP向ISAVRAD数据库提供实时数据传输。中央委员会将 由 Gabriel A. de Erausquin Thomas Patterson 博士、Sudha Seshadri 博士和公共卫生硕士 Mindy Katz 共同领导 现场 PI Rufus Akinyemi（尼日利亚）、Agustin Yecora（阿根廷）和 Malveeka Sharma（西雅图）提供协助。在 除了已经拥有牢固的工作关系之外，他们还拥有数十年的数据收集经验 从不同的和未充分研究的群体中进行纵向数据收集并招募具有以下特征的人员： 失智。