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 面对面管理是当前评估认知和功能的“黄金标准” 阿尔茨海默病和其他痴呆症（ADRD）的远程神经心理学研究。 提倡评估以克服各种准入障碍并降低成本 此外，由于紧迫的挑战和安全问题。 由于 COVID-19 大流行，迫切需要强有力的方法来评估 通过远程评估进行认知监测和功能状态的总体目标。 当前的项目是验证、完善和校准远程认知老化和阿尔茨海默病 疾病研究 (R-CARE) 工具箱，用于评估和监测认知和 该工具箱将包括在最初没有痴呆症的不同老年人样本中的功能。 来自统一数据集神经心理学电池 (UDSNB-3.0) 的测量，补充 临床前 AD 试验中常用的测试对远程测试提出了挑战。 行政管理将被基于平板电脑的计算机化任务取代。我们将招募 600 名员工。 无痴呆症、种族/民族多样化（约 1/3 非西班牙裔黑人、1/3 西班牙裔和 1/3 非西班牙裔） 西班牙裔白人），年龄 ≥ 65 岁的社区居民参与者 A 随机， 平衡设计将用于管理全面的临床和认知电池 两种评估模式（面对面与远程）在基线上相隔 2-6 周， 18 个月和 36 个月时进行数字生物标记随访（计算机化测试和基于语音的测试）。 目的 1：评估心理测量。 远程认知测试的特性，并根据标准现场测试评估其有效性。 目标 2：评估整体认知和认知内部纵向变化的可比性 整个样本的跨评估模式（面对面与远程）的领域以及 按性别和种族/民族定义的亚组 目标 3（探索性）：识别新颖的数字化内容。 为区分临床和病理疾病提供增量有效性的生物标志物 总体而言，这项研究用于测量和预测认知和功能下降。 将验证跨不同认知领域的远程管理测试，提供证据 横截面和纵向有效性，并为不同领域的远程测试提供规范数据 我们的长期目标是开发一个开源、可靠且有效的工具箱。 将使 AD 研究人员和信徒能够评估来自不同背景的老年人 无论是否有能力参加亲自访问。 1