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NAD+ Therapy for Improving Memory & Cerebrovasular Function in Patients with MCI

Award Number: K01AG054731
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/15/2017
PERIOD OF PERFORMANCE END DATE: 03/31/2023

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NAD+ Therapy for Improving Memory & Cerebrovasular Function in Patients with MCI - PROJECT SUMMARY/ABSTRACT Amnestic mild cognitive impairment (aMCI) is the earliest symptomatic stage in the development of Alzheimer's disease (AD), which is among the fastest growing causes of morbidity and mortality in the Unites States. Elevated blood pressure and stiffening of the large elastic arteries (i.e., the aorta and carotid arteries) occurs with aging and is linked to the development of aMCI and AD, primarily through the transmission of damaging pressure waves to the cerebral vasculature, resulting in cerebrovascular dysfunction and neuronal damage. Risk factor modification through positive lifestyle behaviors such as healthy diet and regular aerobic exercise have, thus far, been the most effective strategies for improving cognitive function in patients with aMCI. In this regard, chronic calorie restriction (CR) prevents age-related vascular and cognitive dysfunction, in part by reducing large elastic artery stiffness and blood pressure; however, adherence to CR and other healthy lifestyle behaviors is poor among late middle-aged and older adults. The objective of the parent award (K01 AG054731) is to conduct a randomized, placebo-controlled clinical trial to study the efficacy of a novel NAD-boosting and CR-mimicking compound, nicotinamide riboside (NR), for improving memory in older adults with aMCI by reducing large elastic artery stiffness and blood pressure and increasing cerebral blood flow. Because of the older age of the target population, the parent clinical trial was temporarily placed on hold in March 2020 due to concerns surrounding the novel coronavirus disease (COVID-19) which disproportionately affects older adults. More recently, evidence has emerged linking SARS CoV2 infection (the virus that causes COVID-19) to a wide range of cardiovascular complications including vascular endothelial dysfunction, myocarditis, thrombosis, and ischemic stroke. Importantly, there is evidence of cardiovascular dysfunction even among individuals who did not develop the severe respiratory symptoms attributed COVID-19. Given the higher risk of COVID-19 among older adults and the potential for SARS CoV2 infection to impact the cardiovascular outcomes of the parent trial, there is an urgent need to implement additional protective measures to preserve the safety and integrity of the parent clinical trial. Accordingly, the purpose of this administrative supplement is to address COVID-19-related impact to the parent award by incorporating additional safety measures through the use of enhanced personal protective equipment (PPE), increasing staff to assist with virtual testing sessions, servicing key research equipment that was unused during the period in which the study was on hold, and adding the assessment of SARS CoV2 antibodies to all participants in the parent trial. These additional measures are necessary safely resume the parent clinical trial and protect the integrity of the data allowing us to continue to fulfill an important research objective of NIA by investigating promising interventions for ameliorating cognitive impairment in individuals with aMCI.


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 = -$2,992 )
2024	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	001	6	6/26/2024	SUPPLEMENT FOR EXPANSION	-$155
2024	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	003	6	7/15/2024	SUPPLEMENT FOR EXPANSION	-$749
2024	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	002	6	7/15/2024	NON-COMPETING CONTINUATION	-$1,730
2024	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	000	6	6/26/2024	NON-COMPETING CONTINUATION	-$358
														Subtotal = -$2,992

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	000	6	3/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $190,774 )
2021	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	001	6	3/5/2021	SUPPLEMENT FOR EXPANSION	$57,637
2021	2021	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	000	6	2/23/2021	NON-COMPETING CONTINUATION	$133,137
														Subtotal = $190,774

Issue Date FY: 2020 ( Subtotal = $133,137 )
2020	2020	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	000	5	3/2/2020	NON-COMPETING CONTINUATION	$133,137
														Subtotal = $133,137

Issue Date FY: 2019 ( Subtotal = $133,137 )
2019	2019	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	001	4	3/18/2019	NON-COMPETING CONTINUATION	$133,137
2019	2018	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	000	3	10/23/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $133,137

Issue Date FY: 2018 ( Subtotal = $133,136 )
2018	2018	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	003	3	6/26/2018	NON-COMPETING CONTINUATION	$0
2018	2018	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	002	3	4/30/2018	NON-COMPETING CONTINUATION	$133,137
2018	2017	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST STE 481 572 UCB	BOULDER	CO	80309	BOULDER	USA	Aging Research	004	1	8/1/2018	NEW	-$1
2018	2017	UNIVERSITY OF DELAWARE	220 HULLIHEN HALL	NEWARK	DE	19716	NEW CASTLE	USA	Aging Research	001	2	3/8/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$127,288
2018	2017	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST., RM 479 572 UCB	BOULDER	CO	80303	BOULDER	USA	Aging Research	000	1	3/7/2018	NEW	-$127,288
														Subtotal = $133,136

Issue Date FY: 2017 ( Subtotal = $133,137 )
2017	2017	REGENTS OF THE UNIVERSITY OF COLORADO, THE	3100 MARINE ST., RM 479 572 UCB	BOULDER	CO	80303	BOULDER	USA	Aging Research	000	1	7/5/2017	NEW	$133,137
														Subtotal = $133,137

Grand Total All Awards = $720,329

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NAD+ Therapy for Improving Memory & Cerebrovasular Function in Patients with MCI

Award Number: K01AG054731

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/15/2017

PERIOD OF PERFORMANCE END DATE: 03/31/2023

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