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New biomarkers for early Alzheimer's diagnosis and tauopathy differentiation

Award Number: R03AG085058
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2024
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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New biomarkers for early Alzheimer's diagnosis and tauopathy differentiation - Project Summary Developing minimally invasive and low-cost AD and AD-related dementia (ADRD) tests with high sensitivity and specificity is an urgent and unmet need for early AD diagnosis, differential diagnosis with other tauopathies, monitoring disease severity, predicting disease courses, and assessing effectiveness of drug treatment. In this project we will develop phosphorylated tau (p- tau) new biomarkers for early AD diagnosis and for differentiation of AD from other tauopathies. Through a systemic site-specific p-tau antibody screening, we have identified several new and highly selective p-tau AD biomarkers from postmortem brain tissues. They are not only able to differentiate AD from non-AD tauopathies, but also able to diagnose mild cognitive impairment (MCI), an early disease stage of AD, from cognitively normal subjects with better diagnostic performance than those of existing p-tau biomarkers, p-tau181 and p-tau217. We intend to validate our newly discovered p-tau biomarkers in accessible biofluid plasma and cerebrospinal fluid (CSF) by developing ultrasensitive single molecular array (Simoa) based tests for detection and quantification. Two Specific Aims will be pursued. In Aim 1, we will develop novel biofluid p- tau biomarkers for early AD diagnosis. In Aim 2, we will develop new p-tau biomarkers for differentiating AD from other tauopathies. In both Aims, we will test our new biomarkers with significant number of subjects, extend to premortem patient plasma and CSF samples, and develop ultrasensitive Simoa biomarker tests. We anticipated our work has significant clinical and translational values that may lead to AD and ADRD diagnostic tests with improved sensitivity and specificity.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	NORTH CAROLINA CENTRAL UNIVERSITY	1801 FAYETTEVILLE ST	DURHAM	NC	27707	DURHAM	USA	Aging Research	000	2	10/31/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $150,000 )
2025	2025	NORTH CAROLINA CENTRAL UNIVERSITY	1801 FAYETTEVILLE ST	DURHAM	NC	27707	DURHAM	USA	Aging Research	000	2	11/14/2024	NON-COMPETING CONTINUATION	$135,000
2025	2025	NORTH CAROLINA CENTRAL UNIVERSITY	1801 FAYETTEVILLE ST	DURHAM	NC	27707	DURHAM	USA	Aging Research	001	2	5/8/2025	NON-COMPETING CONTINUATION	$15,000
														Subtotal = $150,000

Issue Date FY: 2024 ( Subtotal = $150,000 )
2024	2024	NORTH CAROLINA CENTRAL UNIVERSITY	1801 FAYETTEVILLE ST	DURHAM	NC	27707	DURHAM	USA	Aging Research	000	1	2/8/2024	NEW	$150,000
														Subtotal = $150,000

Grand Total All Awards = $300,000

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New biomarkers for early Alzheimer's diagnosis and tauopathy differentiation

Award Number: R03AG085058

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/15/2024

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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