Validation of the Remote Cognitive Aging and Alzheimer’s Disease REsearch (R-CARE) Toolbox for Diverse Populations

针对不同人群的远程认知衰老和阿尔茨海默病研究 (R-CARE) 工具箱的验证

• 批准号: 10737723
• 负责人: Ali Ezzati
• 金额: $ 210.19万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 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 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10737723
• 关键词: Acoustics; Address; Advocate; Agreement; Alzheimer' s Disease; Alzheimer' s disease risk; Amyloid beta-Protein; Biological Markers; Black race; COVID-19 pandemic; Calibration; Caring; Classification; Clinical; Clinical Trials; Cognition; Cognitive; Cognitive aging; Cohort Studies; Communities; Complement; Data; Data Collection; Data Set; Dementia; Development; Devices; Digital biomarker; Disease; Disparity; Elderly; Electronic Health Record; Ensure; Ethnic Origin; Ethnic Population; Evaluation; Frail Elderly; Future; Glial Fibrillary Acidic Protein; Goals; Grant; Healthcare Systems; Hispanic; Impaired cognition; Individual; Intervention; Measures; Methods; Modality; Monitor; Neuropsychological Tests; Neuropsychology; Not Hispanic or Latino; Observational Study; Participant; Pathologic; Pathology; Patient Care; Pattern; Performance; Persons; Population Heterogeneity; Property; Psychometrics; Race; Randomized; Research; Research Personnel; Risk; Safety; Sampling; Semantics; Services; Speech; Subgroup; Tablets; Telephone; Testing; Time; Underserved Population; Vaccination; Validation; Videoconferencing; Visit; blood-based biomarker; clinical practice; cognitive performance; cognitive testing; cohort; computerized; cost; design; digital; ethnic diversity; follow-up; functional decline; functional status; human old age (65+); improved; low socioeconomic status; mild cognitive impairment; neurofilament; novel; open source; pandemic disease; pre-clinical; racial diversity; racial population; recruit; remote administration; remote assessment; remote grading; remote visit; sex

ABSTRACT In-person administration is the current “gold-standard” for assessment of cognition and function in studies of Alzheimer’s disease and other dementia (ADRD). Remote neuropsychological assessment has been advocated to overcome various access barriers and decrease costs of neuropsychological services. Moreover, due to the pressing challenges and safety concerns imposed by the COVID-19 pandemic, there is an urgent need for robust methods for assessing and monitoring cognitive and functional status through remote assessments. The overall goal of the current project is to validate, refine, and calibrate the Remote Cognitive Aging and Alzheimer’s Disease REsearch (R-CARE) Toolbox for the assessment and monitoring of cognition and function in a diverse sample of initially dementia-free older adults. The toolbox will include measures from the Uniform Data Set, Neuropsychological Battery (UDSNB-3.0), complemented by frequently used tests in preclinical AD trials. In-person tests that pose challenges for remote administration will be replaced with tablet-based computerized tasks. We will recruit 600 dementia-free, racially/ethnically diverse (~ 1/3 non-Hispanic Black, 1/3 Hispanic, and 1/3 non- Hispanic White), community-residing participants aged ≥65 years. A randomized, counterbalanced design will be used to administer a comprehensive clinical and cognitive battery across both assessment modes (in-person vs. remote) separated by 2-6 weeks at baseline, with follow up visits at 18 and 36 months. Digital biomarkers (computerized tests and speech-based) and ADRD blood-based biomarkers will be collected. AIM 1: To evaluate the psychometric properties of remote cognitive tests and assess their validity against standard in-person tests. AIM 2: To evaluate comparability of longitudinal change in global cognition and within cognitive domains across modes of assessment (in-person vs remote) for the whole sample as well as subgroups defined by sex and race/ethnicity. AIM 3 (exploratory): To identify novel digital biomarkers that provide incremental validity for differentiating clinical and pathological disease stages, and for measuring and predicting cognitive and functional decline. Collectively, this study will validate remotely administered tests across different cognitive domains, provide evidence for cross-sectional and longitudinal validity, and provide normative data for remote tests in diverse populations. Our long-term goal is to develop an open-source, reliable and valid toolbox that would enable AD-researchers and clinicians to evaluate older adults from diverse backgrounds regardless of ability to attend in-person visits. 1

抽象的 面对面管理是评估认知和功能的当前“金标准” 在阿尔茨海默氏病和其他痴呆症（ADRD）的研究中。远程神经心理学 主张评估以克服各种访问障碍，并降低成本 神经心理学服务。而且，由于紧迫的挑战和安全问题 由COVID-19大流行施加，迫切需要进行鲁棒的评估方法 并通过远程评估监视认知和功能状态。总体目标 当前的项目是验证，完善和校准远程认知衰老和阿尔茨海默氏症 疾病研究（R-CARE）工具箱，用于评估和监测认知和监测 在最初无痴呆的老年人的潜水员样本中起作用。该工具箱将包括 统一数据集的措施，神经心理电池（UDSNB-3.0）完成了 通过临床前广告试验中的经常使用的测试。面对面的测试对远程构成挑战 管理将替换为基于平板电脑的计算机任务。我们将招募600 无痴呆症，种族/种族多样性（〜1/3非荷黑色，1/3西班牙裔和1/3非 - 非 - 西班牙裔白色），≥65岁的社区保留参与者。一个随机的， 平衡设计将用于管理全面的临床和认知电池 在两种评估模式（面对面与遥控）中，基线分开了2-6周， 18和36个月的后续访问。数字生物标志物（计算机测试和基于语音的测试） 将收集和基于ADRD的血液生物标志物。目标1：评估心理测量学 远程认知测试的特性，并根据标准面对面测试评估其有效性。 目标2：评估全球认知纵向变化和认知中的比较 整个样本以及 性别和种族/种族定义的亚组。目标3（探索性）：确定新颖的数字 为区分临床和病理疾病的生物标志物提供了逐步有效性 阶段，以及测量和预测认知和功能下降。总体而言，这项研究 将验证跨不同认知领域的远程测试，提供证据 横截面和纵向有效性，并为潜水员提供远程测试的正常数据 人群。我们的长期目标是开发一个开源，可靠和有效的工具箱 将使广告研究者和临床医生能够评估来自潜水员背景的老年人 不管有能力参加面对面的访问。 1