Cognitive sequelae of the biological effects of COVID-19 on the nervous system in a health disparity population

COVID-19 对健康差异人群神经系统的生物效应的认知后遗症

• 批准号: 10228116
• 负责人: JOE VERGHESE
• 金额: $ 30.42万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-25 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10228116
• 关键词: Acute; Admission activity; Africa; African American; American; Ancillary Study; Biological; Biological Markers; Brain; COVID-19; COVID-19 pandemic; COVID-19 patient; COVID-19 severity; Clinical; Clinical Trials; Cognitive; Communities; Computerized Medical Record; Confusion; Coronavirus; Coronavirus Infections; Data; Delirium; Dementia; Diagnosis; Elderly; Enrollment; Ethnic Origin; Ethnic group; High Prevalence; Hispanics; Hospitalization; Impaired cognition; Individual; Infection; Interview; Investigation; Lead; Long-Term Effects; Longitudinal Studies; Longterm Follow-up; Medical; Methods; Nervous system structure; Neuraxis; Neurologic; Neurologic Symptoms; Neuropsychological Tests; Observational Study; Older Population; Organ; Outcome; Participant; Patient Care; Patients; Persons; Primary Health Care; Public Health; Race; Randomized; Randomized Clinical Trials; Recommendation; Reporting; SARS-CoV-2 infection; Serology test; Severities; Single-Blind Study; Survivors; Syndrome; Telephone; Test Result; Time; active control; biological research; cognitive function; cognitive testing; comorbidity; coronavirus disease; dementia care; disease transmission; disorder risk; epidemiology study; health disparity populations; health literacy; high risk; improved; innovation; mild cognitive impairment; novel; pandemic disease; primary outcome; racial and ethnic; recruit; respiratory; risk stratification; screening

This application for an ancillary study to UG3NS105565 is very responsive to NOT-NS-20-051. Early reports of Covid-19 patients demonstrate a high prevalence of neurological symptoms, but the long-term neurological and cognitive outcomes are still unknown. Patients with cognitive complaints at high risk of cognitive decline may be especially vulnerable to neurological sequelae of Covid-19. The 5-Cog study is ongoing single-blind, randomized clinical trial in 1,200 older primary care patients presenting with cognitive complaints who will be randomized to receive either the 5- Cog battery or a 5-minute health literacy. The primary outcome is ‘Improved dementia care’ defined as new Mild Cognitive Impairment syndrome or dementia diagnoses as well investigations or treatments for cognitive impairment. As of June 2020, 453 participants (African-American 34% and non-Black Hispanic 54%) were enrolled in the trial. We propose to cross-enroll all participants to study the long-term effects of Covid-19 infection on cognitive trajectories over a one-year period using remote assessments. Covid status will be ascertained by medical interviews, electronic medical records or serological test results. We hypothesize that COVID-19 infection will be associated with worse cognitive functioning in the months following infection and on long term follow-up, with severity of infection, hospitalization, complexity of treatment and prior cognitive impairment moderating the presentation. We propose the following two aims. Aim 1: To determine the cognitive consequences of Covid-19 infection in older adults with cognitive complaints in a health disparity population. We will track cognitive status using conventional (neuropsychological tests) and novel cognitive assessments (non-linguistic vocal biomarkers). To eliminate risk of disease transmission, all cognitive assessments will be done remotely by telephone every 3 months over a one-year period. Cognitive trajectories will be compared by Covid-19 status as well as by race/ethnicity (African-American and Hispanic). Aim 2: To examine the impact of the clinical severity of Covid-19 infection on cognitive outcomes in a health disparity population. Severity will be assessed clinically as mild or asymptomatic, moderate (require hospitalization) or severe (ICU admission) Covid-19 survivors. The cognitive trajectories will be reported within each clinical severity strata, and compared between Africa-American and Hispanic participants.

UG 3 NS 105565的辅助研究申请对NOT-NS-20-051非常敏感。 新冠肺炎患者的早期报告显示，神经系统症状的患病率很高，但 长期的神经和认知结果仍然未知。患者认知 认知能力下降风险高的投诉可能特别容易受到神经系统疾病的影响。 新冠肺炎后遗症 这项5-Cog研究是一项正在进行的单盲、随机临床试验，在1,200名老年原发性 出现认知主诉的护理患者，将随机接受5- 齿轮电池或5分钟的健康知识。主要成果是“改善痴呆症护理” 定义为新发轻度认知障碍综合征或痴呆诊断以及检查 或认知障碍的治疗。截至2020年6月，453名参与者（非洲裔美国人34%） 和非黑人西班牙裔54%）参加了试验。我们建议交叉招募所有参与者 研究新冠肺炎感染对认知轨迹的长期影响，为期一年 使用远程评估。新冠病毒状态将通过医疗面谈、电子 医疗记录或血清学测试结果。我们假设COVID-19感染将是 与感染后数月内认知功能恶化相关， 随访，包括感染严重程度、住院治疗、治疗复杂性和既往认知 损害缓和的介绍。我们提出以下两个目标。 目的1：确定新冠肺炎感染对老年人的认知后果， 健康差异人群中的认知障碍我们将跟踪认知状态， 传统的（神经心理学测试）和新的认知评估（非语言声乐 生物标志物）。为了消除疾病传播的风险，所有的认知评估都将在 在一年的时间里，每3个月通过电话远程访问一次。认知轨迹将是 按新冠肺炎疫情状况以及种族/民族（非裔美国人和西班牙裔）进行比较。 目的2：研究新型冠状病毒感染的临床严重程度对认知功能的影响 在健康不平等的人群中。严重程度将在临床上评估为轻度或 无症状、中度（需要住院治疗）或重度（入住ICU）Covid-19幸存者。 将在每个临床严重程度分层内报告认知轨迹，并进行比较 非裔美国人和西班牙裔参与者之间的差异。