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

摘要