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Prospective validation and implementation of high-performing blood biomarkers and digital cognitive tests for detection of Alzheimer's disease in specialist memory clinic and primary care settings

Award Number: R01AG083740
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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Prospective validation and implementation of high-performing blood biomarkers and digital cognitive tests for detection of Alzheimer's disease in specialist memory clinic and primary care settings - SUMMARY The recent major breakthroughs in the development of accurate blood-based Alzheimer’s disease (AD) biomarkers, including phospho-tau217 (pTau217), have the potential to truly revolutionize AD diagnostics. However, these novel biomarkers must now be thoroughly validated in a prospective fashion in clinical practice before they can be implemented in the diagnostic and prognostic work-up of AD in specialist clinics and primary care globally. This validation is urgently needed because of the relatively low accuracy of the clinical diagnostic work-up without support of accurate AD biomarkers, resulting in misdiagnoses of 25-30% of AD patients in specialist memory clinics and >50% in primary care. Furthermore, it is important to determine in which patients and real-world clinical settings these novel blood AD biomarkers clearly improve diagnosis, treatment, and care, which is essential for reimbursement in many countries. Finally, we also need accurate prognostic tools to identify those individuals with early AD who are most likely to show imminent clinical decline, because this group may benefit most from targeted interventions. This is highly timely considering the recent advent of disease-modifying AD therapies that may soon become widely available. Given the excellent infrastructure of the primary care system in Sweden and research biomarker protocols already approved and fully integrated in clinical practice, we have a unique opportunity to test these novel blood AD markers in broad, diverse, and unselected populations that are generalizable to other real-world settings. To achieve this ambitious goal, we will conduct two novel and unique prospective studies in specialist memory clinic (n=800) and general primary care (n=800) settings. First, we aim to prospectively validate plasma AD biomarkers for the diagnosis of patients with cognitive symptoms evaluated in either specialist memory clinics or in primary care. Following recent expert consensus recommendations, we will use i) predefined biomarker cut-offs, ii) bi- weekly analysis of the plasma samples and iii) appropriate reference standards (i.e., PET/CSF). We anticipate that we will identify - within 48 months - AD blood biomarkers with high potential for implementation in memory clinic and/or primary care settings. Second, we will determine whether blood-based AD biomarkers improve patient management in specialist memory clinic settings and general primary care settings. Demonstrating improvements of the AD diagnostic work-up and treatment when compared to “care-as-usual” is essential for regulatory authorities to approve future reimbursement of blood-based biomarkers. Third, we aim to optimize the prognosis of patients with early AD by combining (prospectively analyzed) plasma AD biomarkers with brief digital cognitive tests. The expected outcome is a combination of easily accessible and time- and cost-effective blood biomarkers and digital cognitive tests that can predict short-term cognitive decline and progression to AD dementia in primary care. At the end of this project, our expected goal is that blood-based biomarkers and prognostic algorithms will be ready for clinical implementation in both specialist clinics and primary care.


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 = $471,388 )
2026	2026	LUNDS UNIVERSITET	KYRKOGATAN 8	LUND				SWE	Aging Research	000	4	5/19/2026	NON-COMPETING CONTINUATION	$471,388
														Subtotal = $471,388

Issue Date FY: 2025 ( Subtotal = $471,227 )
2025	2025	LUNDS UNIVERSITET	BISKOPSGATAN 5	LUND				SWE	Aging Research	001	3	7/9/2025	NON-COMPETING CONTINUATION	$471,227
2025	2024	LUNDS UNIVERSITET	BISKOPSGATAN 5	LUND				SWE	Aging Research	000	2	4/1/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $471,227

Issue Date FY: 2024 ( Subtotal = $493,479 )
2024	2024	LUNDS UNIVERSITET	BISKOPSGATAN 5	LUND				SWE	Aging Research	000	2	5/20/2024	NON-COMPETING CONTINUATION	$493,479
														Subtotal = $493,479

Issue Date FY: 2023 ( Subtotal = $499,999 )
2023	2023	LUNDS UNIVERSITET	PARADISGATAN 2	LUND				SWE	Aging Research	000	1	8/25/2023	NEW	$499,999
														Subtotal = $499,999

Grand Total All Awards = $1,936,093

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Prospective validation and implementation of high-performing blood biomarkers and digital cognitive tests for detection of Alzheimer's disease in specialist memory clinic and primary care settings

Award Number: R01AG083740

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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