# Clinical Core

> **NIH NIH U19** · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · 2024 · $2,516,114

## Abstract

CC Summary Abstract
The proposed Study on Interactions between SARS-CoV-2 infection and Ancestral genomic Variations in the
Risk of Alzheimer's Disease (ISAVRAD) requires significant coordination across the five data collection sites
(Argentina, Nigeria, and 3 sites in the US: Texas, NY, and Washington state) and 3 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 at
baseline, and will conduct follow-up evaluations at 18 and 36 months. Clinical evaluations will include medical
and epidemiological histories focused on SARS- CoV-2 infection, including COVID-19 case report forms (CRFs)
harmonized by the WHO, neuropsychological assessment (including Uniform Data Set and a tablet-based,
language-independent assessment), neurological examination, and completion of the semi-structured interview
Schedules for Clinical Assessment in Neuropsychiatry of the World Health Organization (WHO SCAN), as well
as informant report. At all data collection time-points, the CC will also collect and ship blood biospecimens to
carry out point-of-care COVID-19 antibody testing, extract DNA, and bank whole blood and plasma for future
collaborative studies. It will also screen participants for MRI and harmonize MRI and PET data acquisition at
all sites, sending imaging results to the Neuroimaging Core. The CC will also conduct case conferences to
assign diagnostic clinical outcomes according to cognitive impairment level/ADRD status (unimpaired, Mild
cognitive impairment, dementia syndrome with disease-specific etiologies). Disease specific etiologies will
include AD, Lewy-Body Dementia, Vascular Dementia, Frontal Lobe Dementia, and mixed. Finally, the CC will
employ a sophisticated data capture system, collaboratively developed with the Data Management and
Statistics Core, to provide real- time data transmission to the ISAVRAD database via RedCAP. The CC will be
co-lead by Dr. Gabriel A. de Erausquin Thomas Patterson, Dr. Sudha Seshadri, and Mindy Katz, MPH with the
assistance of site PIs Rufus Akinyemi (Nigeria), Agustin Yecora (Argentina) and Malveeka Sharma (Seattle). In
addition to already having a strong working relationship, they have decades of experience in data collection
from diverse and understudied cohorts, longitudinal data collection, and recruitment of persons with
dementia.

## Key facts

- **NIH application ID:** 10907429
- **Project number:** 5U19AG076581-02
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
- **Principal Investigator:** GABRIEL Alejandro DE ERAUSQUIN
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,516,114
- **Award type:** 5
- **Project period:** 2023-08-15 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10907429

## Citation

> US National Institutes of Health, RePORTER application 10907429, Clinical Core (5U19AG076581-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10907429. Licensed CC0.

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