Clinical Core (CC)
Overview
ISAVRAD requires significant coordination across the data collection sites and research projects. In support of the goals of ISAVRAD, the Clinical Core (CC) will enroll and conduct in-depth clinical evaluations of 4,300 older adults with (75% of the sample) and without (25% of the sample) exposure to SARS-CoV-2 within the first two years of the pandemic. Data collection occurs at the initial baseline visit, and includes follow-up evaluations at 18 and 36 months.
Participating Institutions
- UT Health SA (San Antonio, TX and Laredo, TX)
- City of Laredo (Laredo, TX)
- FULTRA (Jujuy, Argentina)
- Albert Einstein College of Medicine (Bronx, NY)
- University of Washington (Seattle, WA)
- University of Ibadan (Ibadan, Nigeria)
Aim 1
Conduct evaluations of older adults post-exposure to SARS-CoV-2 at baseline (within one year of recovery) and at 18 and 36 months follow-up visits according to standardized CC protocols. After informed consent and initial enrollment, baseline evaluations include detailed case report forms for COVID-19, neuropsychological assessment, semiquantitative neurological examination, semi-structured behavioral neurology interviews, and additional relevant data. Provide follow-up examinations at 18 and 36 months for all participants using standardized assessments administered either at baseline. To ensure continuous reliability of data collection, oversee and conduct standardized training and periodic re-assessment in CC procedures for clinicians.
Aim 2
Collect and Distribute, in coordination with the Administrative Core, data and biosamples to the Projects and Cores, according to established criteria. To support the mission of ADSP and Project 2, CC will obtain/distribute purified DNA for whole genome sequencing. Additional blood and plasma specimens will be biobanked for future use by a biomarkers project submitted separately to the Alzheimer’s Association. To support the Neuroimaging Core, CC will screen participants for MRI and PET acquisition, and harmonize acquisition of MRI data at all clinical sites.
Aim 3
Assign diagnostic clinical outcomes according to stage on the ADRD continuum annually for each participant using an iterative process. Assign a neurological impression of cognitive status based on the neurological evaluation. Assign a neuropsychological impression of cognitive status based on the neuropsychological evaluation. Assign a final consensus diagnosis of cognitively unimpaired, Mild Cognitive Impairment (MCI), or dementia syndrome with disease-specific etiologies including AD, Lewy-Body Dementia, Vascular Dementia, Frontal Lobe Dementia, and mixed dementia, by combining the neurological and neuropsychological impressions with results from behavioral, functional and informant assessments.
Aim 4
Collect and maintain longitudinal clinical, cognitive, and diagnostic outcomes data. The CC’s sophisticated data capture system, collaboratively developed with the Data Management and Statistics Core, will provide real-time data transmission to the ISAVRAD database via RedCAP.
Core Leadership
- Dr. Gabriel de Erausquin – Co-Director – UT Health San Antonio
- Dr. Sudha Seshadri – Co-Director – UT Health San Antonio
- Ms. Mindy Katz – Co-Director – Albert Einstein College of Medicine
- Dr. Thomas Patterson – Co-Director – UT Health San Antonio
- Dr. Agustin Yecora – Site PI – FULTRA, Argentina
- Dr. Rufus Akinyemi – Site PI – University of Ibadan, Nigeria
- Dr. Kendl Sankary – Site Co-PI – University of Washington, Seattle
- Dr. Nikki Gentile – Site Co-PI – University of Washington, Seattle
Data and Resource Sharing
The AC oversees sharing study resources with external investigators, promoting collaborations. Resource transfer agreements are managed through the Data Management & Statistics Core and deposited in NIH-maintained repositories, including NACC, NCRAD, and NIAGADS.