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Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)

Award Number: R01AG050657
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2016
PERIOD OF PERFORMANCE END DATE: 02/28/2023

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Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind) - DESCRIPTION (provided by applicant): Identifying a safe, affordable, and well-tolerated intervention that prevents cognitive decline in older adults is of critical public health importanc. There is compelling evidence from basic science, and small clinical studies that cocoa flavanols may protect cognitive function in older adults and reduce risk of Alzheimer's disease (AD) and related dementia. Thus, this intervention could have important downstream benefits for health care utilization and cost, caregiver burden, and overall quality of life for older adults. Cocoa flavanol effects on cognition, however, need to be assessed in a definitive clinical trial. We propose to leverage the unique and timely opportunity provided by the funded COcoa Supplement and Multivitamin Outcomes Study (COSMOS) to conduct an ancillary cognitive study, referred to as "COSMOS-Mind." COSMOS is a randomized, double-blind, placebo-controlled clinical trial that will begin randomization in early 2016. It will enroll 18,000 women and men nationwide, drawn from the Women's Health Initiative (WHI) participant cohort and the VITamin D and OmegA- 3 TriaL (VITAL) non-randomized respondent cohort, and will be conducted primarily by mail. COSMOS will assess whether high-potency cocoa flavanol extract (capsules containing 750 mg/d flavanols, including 75 mg (-)-epicatechin, and 90 mg theobromine; Mars Symbioscience) and a multivitamin (Pfizer Centrum(r) Silver(r)) - alone or in combination - will reduce risk of cardiovascular disease and cancer over 4 years of follow-up. The COSMOS leadership invited us to conduct an ancillary study to examine the cognitive effects of their interventions, given our extensive and successful experience collecting cognitive data using cost-effective and validated telephone-administered assessments in the geographically diverse WHI cohort. COSMOS-Mind will enroll 2,000 participants from COSMOS (50% men, aged ≥65 years), and conduct standardized telephone cognitive assessments pre-randomization and annually for 3 years to examine longitudinal effects of cocoa flavanols on a cognitive composite outcome. We will also establish whether administration of a multivitamin benefits cognition, explore whether cocoa flavanols reduce risk of dementia including AD, and examine intervention effects on key cognitive domains (e.g., executive function, short-term memory). Our assessments will yield reliable and sensitive measures of memory, executive function, language, and global cognitive function. We will use our previously successful techniques to promote high retention and longitudinal reliability. Our proposed cohort will provide >90% statistical power to establish whether cocoa flavanols protect cognitive function. We will share our data with the COSMOS study groups, WHI, and VITAL to facilitate other investigations and expand the scientific footprint of our study. COSMOS-Mind is an unprecedented, cost- efficient, and timely opportunity to test whether cocoa flavanols - a promising and widely translatable intervention - can protect against normal and pathological cognitive decline.


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 = $0 )
2024	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	5	12/4/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	5	3/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $745,427 )
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	5	3/23/2020	NON-COMPETING CONTINUATION	$745,427
														Subtotal = $745,427

Issue Date FY: 2019 ( Subtotal = $752,194 )
2019	2019	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	4	2/15/2019	NON-COMPETING CONTINUATION	$752,194
														Subtotal = $752,194

Issue Date FY: 2018 ( Subtotal = $766,823 )
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	001	3	4/25/2018	NON-COMPETING CONTINUATION	$76,682
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	3	2/8/2018	NON-COMPETING CONTINUATION	$690,141
2018	2018	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	002	3	5/2/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $766,823

Issue Date FY: 2017 ( Subtotal = $777,267 )
2017	2017	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	001	2	6/14/2017	NON-COMPETING CONTINUATION	$77,726
2017	2017	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	2	2/15/2017	NON-COMPETING CONTINUATION	$699,541
														Subtotal = $777,267

Issue Date FY: 2016 ( Subtotal = $806,500 )
2016	2016	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BOULEVARD	WINSTON SALEM	NC	27157	FORSYTH	USA	Aging Research	000	1	5/17/2016	NEW	$806,500
														Subtotal = $806,500

Grand Total All Awards = $3,848,211

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Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-Mind)

Award Number: R01AG050657

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2016

PERIOD OF PERFORMANCE END DATE: 02/28/2023

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