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.

该辅助研究对UG3NS105565进行的辅助研究对Not-NS-20-051的响应非常敏感。 Covid-19患者的早期报道表明神经系统符号的患病率很高，但 长期神经和认知结果仍然未知。认知患者 认知能力下降的高风险的投诉可能特别容易受到神经系统的影响 Covid-19的后遗症。 5-COG研究正在进行的单盲，随机临床试验中 护理患者出现认知投诉的患者将被随机分配给5-- COG电池或5分钟的健康素养。主要结果是“改善痴呆症护理” 定义为新的轻度认知障碍综合征或痴呆诊断，并研究 或认知障碍的治疗方法。截至2020年6月，有453名参与者（非裔美国人34％ 和非黑西班牙裔54％）参加了试验。我们建议交叉注册所有参与者 研究Covid-19感染对认知轨迹的长期影响一年 使用远程评估。医学访谈，电子访谈将确定COVID身份 病历或血清学检查结果。我们假设Covid-19感染将是 在感染后的几个月和长期的几个月中，认知功能较差 随访，感染的严重程度，住院，治疗的复杂性和先前的认知 损害调节演示文稿。我们提出以下两个目标。 目标1：确定Covid-19感染的认知后果 健康差异人群中的认知投诉。我们将使用 常规（神经心理学测试）和新颖的认知评估（非语言声音 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 在一年的时间内每3个月一次通过电话远程电话。认知轨迹将是 与Covid-19的身份以及种族/种族（非裔美国人和西班牙裔）相比。 目的2：检查Covid-19感染的临床严重程度对认知的影响 健康差异人群的结果。严重程度将在临床上评估为轻度或 无症状，中度（需要住院）或严重的（ICU入院）Covid-19-19。 认知轨迹将在每个临床严重程度层中报告，并比较 在非洲裔美国人和西班牙裔参与者之间。