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.

UG3NS105565的辅助研究申请对NOT-NS-20-051非常敏感。 早期关于新冠肺炎患者的报告显示，神经系统症状的发生率很高，但 长期的神经和认知结果仍不得而知。认知障碍患者 认知功能衰退的高危主诉可能特别容易受到神经系统的影响。 新冠肺炎的后遗症。 这项5-Cog研究正在1200名老年初选患者中进行单盲随机临床试验 护理有认知主诉的患者，他们将被随机接受5- COG电池或5分钟的健康知识。其主要结果是“改善了痴呆症的治疗” 定义为新的轻度认知障碍综合征或痴呆症的诊断以及调查 或认知障碍的治疗。截至2020年6月，453名参与者(非裔美国人34% 和非黑人西班牙裔美国人)参加了试验。我们建议对所有参与者进行交叉注册 用一年时间研究新冠肺炎感染对认知轨迹的长期影响 使用远程评估。Covid状态将通过医学面谈、电子 医疗记录或血清学检测结果。我们假设新冠肺炎感染将是 在感染后的几个月内和长期内认知功能较差 随访，包括感染的严重程度、住院情况、治疗的复杂性和既往认知 减损影响演示文稿。我们提出了以下两个目标。 目的1：确定新冠肺炎感染对老年人认知功能的影响 健康差距人群中的认知投诉。我们将使用以下工具跟踪认知状态 常规(神经心理测试)和新的认知评估(非语言发声 生物标志物)。为了消除疾病传播的风险，将进行所有认知评估 在一年期间，每3个月远程打电话一次。认知轨迹将是 按新冠肺炎地位以及种族/族裔(非裔美国人和西班牙裔)进行比较。 目的2：探讨新冠肺炎感染的临床严重程度对认知功能的影响 在健康差距人群中的结果。严重程度将在临床上评估为轻度或 无症状、中度(需要住院)或重度(ICU入院)新冠肺炎幸存者。 认知轨迹将在每个临床严重程度级别内报告，并进行比较 在非洲裔美国人和西班牙裔参与者之间。