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Multi-center development of a novel diagnostic test for Alzheimer's disease

Award Number: R01AG059424
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Multi-center development of a novel diagnostic test for Alzheimer's disease - Summary As the number of Alzheimer's disease (AD) patients increases rapidly, a simple and specific blood test to diagnose AD is needed. Our recent research discovered that a single peripheral injection of pramlintide can move amyloid-β peptide (Aβ) from the brain into the blood in AD mouse models, and the level of Aβ increase in the blood correlates well with the existing amount of Aβ in the brain. Based on this finding, the proposed study is to further the development of a blood test for AD patients that we initiated by a single injection of pramlintide as the challenge for biomarker changes in blood. This challenge test will be a diagnostic test for AD similar in principle to the glucose tolerance test that shows abnormalities specifically in diabetic patients. The central hypothesis is that a single pramlintide injection will significantly induce a change in a group of AD-related factors in the blood of AD patients but not in those with normal cognition, and the signature of these changes will correlate with the AD biomarkers in the central nervous system (CNS). We will recruit 240 subjects from 3 clinical research centers to conduct the pramlintide challenge test. There will be three specific aims. Aim 1 is to investigate whether a single injection of pramlintide induces a dose-dependent increase in Aβ in the blood of AD patients. Aim 2 is to investigate whether the pattern of AD biomarker changes in the pramlintide challenge test correlates with AD biomarkers in CSF. Aim 3 is to determine whether the pattern of AD biomarker changes in the pramlintide challenge test correlate with amyloid burden in the brain. Pramlintide is non-amyloidogenic amylin analog, and is an FDA-approved drug for diabetes with a favorable safety profile. Should our proposed study support the concept of the amylin challenge test as a diagnostic test for AD, this test will be able to be conducted in a doctor's office. 1


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 = -$11,512 )
2026	2022	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	5	12/2/2025	NON-COMPETING CONTINUATION	-$11,512
														Subtotal = -$11,512

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	5	4/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,266,625 )
2022	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	5	6/14/2022	NON-COMPETING CONTINUATION	$1,266,625
														Subtotal = $1,266,625

Issue Date FY: 2021 ( Subtotal = $1,275,411 )
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	4	5/13/2021	NON-COMPETING CONTINUATION	$1,275,411
														Subtotal = $1,275,411

Issue Date FY: 2020 ( Subtotal = $1,275,411 )
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	3	6/12/2020	NON-COMPETING CONTINUATION	$1,275,411
														Subtotal = $1,275,411

Issue Date FY: 2019 ( Subtotal = $1,275,411 )
2019	2019	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	2	5/27/2019	NON-COMPETING CONTINUATION	$1,275,411
														Subtotal = $1,275,411

Issue Date FY: 2018 ( Subtotal = $1,306,078 )
2018	2018	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Aging Research	000	1	8/27/2018	NEW	$1,306,078
														Subtotal = $1,306,078

Grand Total All Awards = $6,387,424

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Multi-center development of a novel diagnostic test for Alzheimer's disease

Award Number: R01AG059424

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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