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Centrally-linked longitudinal peripheral biomarkers of AD in multi-ethnic populations

Award Number: U19AG074879
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2023
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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Centrally-linked longitudinal peripheral biomarkers of AD in multi-ethnic populations - Revised Summary Abstract Existing cerebrospinal fluid (CSF) and neuroimaging measures of amyloid ß, tau and neurodegeneration (A,T,N) serve as useful diagnostic biomarkers for Alzheimer’s disease (AD), however there remains an urgent, unmet need for blood based biomarkers in AD. First, multi-omic studies discovered many perturbed biological pathways in AD, however, systematic studies for biomarkers that capture these diverse biological facets of AD are limited. Second, AD is a heterogeneous disorder but biomarkers that can distinguish the biological subtypes of AD are lacking. Third, core AD neuropathology often co-exists with other neuropathologies such as vascular disease (V). These co-morbidities and co-pathologies need to be considered in biomarker discovery. Fourth, existing biomarker studies are heavily focused on non-Hispanic Whites (NHW). Similar studies in multi-ethnic populations (MEP) are needed. This U19, bringing together >40 experts across 13 institutions, aims to bridge these knowledge gaps for discovery and validation of Centrally-linked Longitudinal pEripheral biomARkers of AD (CLEAR-AD) in multi-ethnic populations. CLEAR-AD U19 is based on the premise that AD is a complex disorder in which many biological pathways are disrupted due to multi-omic perturbations, which can be detected in brain and reflected in blood, i.e. centrally-linked peripheral molecular signatures (CLPMS). The specific aims of CLEAR-AD U19 are: 1) To discover CLPMS of the complex and heterogeneous AD pathophysiology and its co-pathologies. 2) To identify longitudinal CLPMS that detect and predict dynamic neuroimaging, fluid biomarker, and clinical changes across AD spectrum. 3) To characterize differences and similarities in CLPMS profiles across NHW, African American (AA) and Latino American (LA) participants to uncover biomarker patterns in multi-ethnic groups. 4) To make these vast resources available to the scientific community to amplify and accelerate its impact. In this U19 managed by the Administrative Core, we will leverage NIH-funded ADNI, MCSA and ADRC cohorts of >3,700 multi-ethnic participants to generate >20,000 multi-omics measures (Omics Core) that will be processed and integrated with >48,000 harmonized AD cognitive, neuroimaging and fluid endophenotypes (Analytic Core). Using these data, we will identify brain region and cell-type specific CLPMS, which reflect biological subtypes of AD and disease stage (Project 1). We will discover longitudinal changes in CLPMS that predict cognitive and A/T/N/V progression (Project 2). We will define longitudinal cognitive and A/T/N/V changes and CLPMS in MEP that are either conserved with NHW or population-specific (Project 3). This U19 will a) Identify the next generation of AD biomarkers with mechanistic insights; b) Establish a precision medicine approach for rigorous multi-omics biomarker discovery and validation in AD; c) Discover molecules that can serve as biomarkers and therapeutic targets; d) Enhance biomarker research in trial-ready multi-ethnic populations; and e) Generate and share a vast and harmonized resource of endophenotype and multi-omics data in NIH-funded cohorts.


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 = $8,164,281 )
2026	2026	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	001	4	7/21/2026	NON-COMPETING CONTINUATION	$0
2026	2026	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	000	4	6/11/2026	NON-COMPETING CONTINUATION	$8,164,281
														Subtotal = $8,164,281

Issue Date FY: 2025 ( Subtotal = $9,157,485 )
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	003	3	4/1/2025	NON-COMPETING CONTINUATION	$0
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	005	3	9/15/2025	NON-COMPETING CONTINUATION	$0
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	002	3	3/25/2025	NON-COMPETING CONTINUATION	$8,409,935
2025	2025	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	004	3	7/31/2025	NON-COMPETING CONTINUATION	$747,550
2025	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	000	2	10/17/2024	NON-COMPETING CONTINUATION	$0
2025	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	001	2	12/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $9,157,485

Issue Date FY: 2024 ( Subtotal = $8,291,222 )
2024	2024	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	000	2	4/15/2024	NON-COMPETING CONTINUATION	$8,291,222
														Subtotal = $8,291,222

Issue Date FY: 2023 ( Subtotal = $8,248,338 )
2023	2023	MAYO CLINIC JACKSONVILLE (A NONPROFIT CORPORATION)	4500 SAN PABLO RD S	JACKSONVILLE	FL	32224	DUVAL	USA	Aging Research	000	1	3/14/2023	NEW	$8,248,338
														Subtotal = $8,248,338

Grand Total All Awards = $33,861,326

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Centrally-linked longitudinal peripheral biomarkers of AD in multi-ethnic populations

Award Number: U19AG074879

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 03/15/2023

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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