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.

抄送摘要 SARS-CoV-2感染与人类祖先基因组变异的相互作用研究 阿尔茨海默病风险(ISAVRAD)需要在五个数据收集站点之间进行重大协调 (阿根廷、尼日利亚和美国的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……里面 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 4300名接触过SARS-CoV-2的老年人(75%的样本)和没有接触过SARS-CoV-2的老年人(25%的样本)在 并将在18个月和36个月时进行后续评价。临床评估将包括医疗 以及以SARS-CoV-2感染为重点的流行病学历史，包括新冠肺炎病例报告表(CRF) 经世卫组织协调，神经心理评估(包括统一数据集和基于平板的、 语言独立评估)、神经学检查和完成半结构化面谈 世界卫生组织神经精神病学临床评估时间表(世卫组织扫描) 作为告密者的报告。在所有数据收集时间点，CC还将收集血液生物检验品并将其运往 进行看护点新冠肺炎抗体检测，提取脱氧核糖核酸，并储存全血和血浆，以备将来使用 合作研究。它还将对参与者进行MRI筛查，并在以下位置协调MRI和PET数据采集 所有地点，将成像结果发送到神经成像核心。消委会亦会举行个案会议，以 根据认知损害程度/ADRD状态(无损害、轻度)分配诊断临床结果 认知障碍、痴呆症候群和疾病特有的病因)。疾病特定的病因将 包括阿尔茨海默病、路易体痴呆、血管性痴呆、额叶痴呆和混合性痴呆。最后，消委会将 采用复杂的数据捕获系统，与数据管理和 统计核心，通过RedCap向ISAVRAD数据库提供实时数据传输。消委会将是 由Gabriel A.de Erausquin Thomas Patterson博士、Souha Seshadri博士和Mindy Katz博士共同领导，公共卫生硕士 现场绩效指标Rufus Akinyemi(尼日利亚)、Agustin Yecora(阿根廷)和Malveeka Sharma(西雅图)的协助。在……里面 除了已经建立了牢固的工作关系外，他们还拥有数十年的数据收集经验 从不同的和研究不足的队列、纵向数据收集和招募具有以下特征的人员 痴呆症。