# An Alzheimer's Blood Test for Primary Care

> **NIH NIH R01** · UNIVERSITY OF NORTH TEXAS HLTH SCI CTR · 2020 · $2,168,034

## Abstract

PROJECT SUMMARY
A primary aim of PAR-15-359 “Novel Approaches to Diagnosing Alzheimer's Disease & Predicting
Progression” is to “identify new biomarkers that are minimally invasive, inexpensive and that could be used for
screening a general population.” Further, this PAR states that “A biomarker that could be used for screening in
primary-care settings would be particularly useful.” The Centers for Medicare & Medicaid Services (CMS)
Annual Wellness Visit (AWV) includes a cognitive examination (CMS.gov); however, the 2015 Gerontological
Society of American working group reported that “older adults are inadequately assessed for cognitive
impairment during routine visits with their primary care providers”. This report further states that without a
diagnosis, individuals with AD do not “benefit from post-diagnostic medical care” that can “lead to improved
health-related outcomes and well-being”. Here we propose the first-ever examination of an AD Blood Test as
the first-step in this multi-tier diagnostic process beginning in primary care.
The PIs are global experts in blood-based biomarkers of AD and longitudinal studies of AD. PI O'Bryant has
followed the Institute of Medicine (IOM) guidelines for the development and validation of the AD Blood Test,
which has been validated across cohorts, assay platforms, tissues type, animal models, and ethnicities. We
will leverage a substantial existing infrastructure and resources to address the following Specific Aims: Aim 1:
Validate the Alzheimer's Blood Test in Primary Care Settings; Aim 2: Validate the Alzheimer's Blood Test for
the Detection of Prodromal AD in Primary Care Settings.
The current proposal is highly significant for several reasons: (1) The AD Blood Test will provide primary care
providers globally with a cost-effective means for detecting AD in routine clinical practice by selecting only
those patients that require additional costly and invasive follow-up confirmatory diagnostic procedures; (2) The
AD Blood Test will provide a means for reducing screening costs in prevention trials by over 50%; and finally
(3) The AD Blood Test will provide a rapidly scalable means for increasing access to novel therapies globally
once Regulatory approval is obtained.

## Key facts

- **NIH application ID:** 9961461
- **Project number:** 5R01AG058537-03
- **Recipient organization:** UNIVERSITY OF NORTH TEXAS HLTH SCI CTR
- **Principal Investigator:** Sid E O'Bryant
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,168,034
- **Award type:** 5
- **Project period:** 2018-06-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9961461

## Citation

> US National Institutes of Health, RePORTER application 9961461, An Alzheimer's Blood Test for Primary Care (5R01AG058537-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9961461. Licensed CC0.

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