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

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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