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A Blood Test for Screening Into Alzheimer's Prevention Trials

Award Number: R01AG058252
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2017
PERIOD OF PERFORMANCE END DATE: 06/30/2023

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A Blood Test for Screening Into Alzheimer's Prevention Trials - PROJECT SUMMARY The Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) study (http://a4study.org/) is a ground-breaking study designed prevent cognitive decline among cognitively normal older adults who are amyloid positive. If successful, the A4 trial will demonstrate, for the first time, that it is possible to delay this devastating disease by initiating treatments prior to clinical manifestation. Such success would engender an effort to make treatments available globally. However, the only currently available means for screening older adults into potential trials (or regularity approved therapy) for amyloid-removing medications are amyloid PET scans or lumbar punctures (LPs), neither of which are viable options for large-scale screening. Here we propose to meet the objectives of PAR-15-359 by leveraging existing biorepository samples from the A4 trial. The long-term goal of this work is the establishment of a multi-tier neurodiagnostic approach for screening eligible older adults into clinical trials (and clinical intervention) of anti-amyloid agents to slow and/or prevent AD progression. The PIs are global leaders in blood-based biomarkers of AD. This project will leverage a substantial existing infrastructure to address the following Specific Aims: Aim 1: Validate our AD blood screen as the first step in screening cognitively normal older adults into prevention trials using anti-amyloid agents. Aim 2: Determine the accuracy of neuronally derived exosomes (NDEs) for screening cognitively normal older adults into prevention trials using anti-amyloid agents. Aim 3: Demonstrate the cost-benefit of a multi-tier screening process for enrollment into prevention studies of AD. The significance of the current proposal is the completion of the first-ever study of a blood-based Alzheimer's screening test as the first-step in a multi-tier screening process for prevention trials. The availability of such a process would increase access to both clinical trials and medications once FDA approved and provide a previously utilized strategy for reimbursement approval from other diseases.


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: 2024 ( Subtotal = -$732 )
2024	2021	THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	5	1/22/2024	NON-COMPETING CONTINUATION	-$732
														Subtotal = -$732

Issue Date FY: 2021 ( Subtotal = $560,088 )
2021	2021	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	5	6/17/2021	NON-COMPETING CONTINUATION	$560,088
														Subtotal = $560,088

Issue Date FY: 2020 ( Subtotal = $560,088 )
2020	2020	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	4	5/27/2020	NON-COMPETING CONTINUATION	$560,088
														Subtotal = $560,088

Issue Date FY: 2019 ( Subtotal = $924,882 )
2019	2019	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	3	8/5/2019	NON-COMPETING CONTINUATION	$560,088
2019	2019	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	001	3	8/7/2019	SUPPLEMENT FOR EXPANSION	$364,794
														Subtotal = $924,882

Issue Date FY: 2018 ( Subtotal = $567,388 )
2018	2018	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	2	6/25/2018	NON-COMPETING CONTINUATION	$567,388
														Subtotal = $567,388

Issue Date FY: 2017 ( Subtotal = $578,888 )
2017	2017	UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH	3500 CAMP BOWIE BLVD	FORT WORTH	TX	76107	TARRANT	USA	Aging Research	000	1	9/14/2017	NEW	$578,888
														Subtotal = $578,888

Grand Total All Awards = $3,190,602

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A Blood Test for Screening Into Alzheimer's Prevention Trials

Award Number: R01AG058252

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2017

PERIOD OF PERFORMANCE END DATE: 06/30/2023

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