COcoa Supplement and Multivitamin Outcomes Study for the Mind
COSMOS-Mind
2 other identifiers
observational
2,262
1 country
1
Brief Summary
The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. A cognitive ancillary study (COSMOS-Mind) is being conducted among men and women, 65 years and older, who are enrolled in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement improves cognitive function and reduces risk of cognitive impairment, including Alzheimer's disease (AD) and other related types of dementia. Participants at the Wake Forest site will only be getting a phone call.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2021
CompletedResults Posted
Study results publicly available
August 22, 2023
CompletedAugust 22, 2023
May 1, 2023
4.5 years
January 20, 2017
March 3, 2023
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Cognitive Function: Average Change Over Follow-up From Baseline
A composite cognitive measure that averages individual test z-scores of the Telephone Interview for Cognitive Status-modified (TICSm) Total and Long, the Immediate and Delayed Story Recall tests, the Oral Trail Making A and B tests (log-transformed), the Category Fluency and Verbal Fluency tests, and the Number Span Backward and Forward tests. Scores are ordered so that better performance corresponds to higher positive scores. Longitudinal data are used to create a linear contrast for the primary analysis to compare the difference between the average of scores at Years 1, 2, and 3 and the baseline score, i.e. (z1+z2+z3)/3 - z0, where z's denote the composited measures at baseline and years 1-3. This contrast is fitted using a random effects model for repeated measures. The primary comparison is for the margins of the factorial design: active cocoa flavonal (with or without active multivitamin) versus placebo flavonal (with or without active multivitamin).
From Baseline through Year 3
Secondary Outcomes (7)
Composite Cognitive Function
From baseline through year 3
Incident Mild Cognitive Impairment
From baseline through year 3
Incidence of Mild Cognitive Impairment Among Those Free at Baseline
From baseline through year 3
Executive Function
From baseline through year 3
Episodic Memory
From baseline through year 3
- +2 more secondary outcomes
Study Arms (4)
Cocoa extract + multivitamin (MTV)
2 capsules containing 500 mg/d cocoa extract; daily MTV
Cocoa extract + multivitamin placebo
2 capsules containing 500 mg/d cocoa extract; daily MTV placebo
Cocoa extract placebo + multivitamin
Cocoa extract placebo (2 capsules/d); daily MTV
Cocoa extract placebo + multivitamin placebo
Cocoa extract placebo (2 capsules/d); daily MTV placebo
Eligibility Criteria
COSMOS-Mind will include 2,000 participants from the COSMOS parent trial who are at least 65 years of age, with approximately equal distribution of women and men.
You may qualify if:
- Men and women 65 years and older.
- Willingness to participate.
- Ability to answer questions by phone.
You may not qualify if:
- Participants who are co-enrolled in the WHI Memory Study.
- Participants with insulin-dependent diabetes.
- Participants who are unable to complete the baseline cognitive assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wake Forest University Health Scienceslead
- National Institute on Aging (NIA)collaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Related Publications (2)
Vyas CM, Manson JE, Sesso HD, Cook NR, Rist PM, Weinberg A, Moorthy MV, Baker LD, Espeland MA, Yeung LK, Brickman AM, Okereke OI. Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS. Am J Clin Nutr. 2024 Mar;119(3):692-701. doi: 10.1016/j.ajcnut.2023.12.011. Epub 2024 Jan 18.
PMID: 38244989DERIVEDBaker LD, Rapp SR, Shumaker SA, Manson JE, Sesso HD, Gaussoin SA, Harris D, Caudle B, Pleasants D, Espeland MA; COSMOS-Mind Research Group. Design and baseline characteristics of the cocoa supplement and multivitamin outcomes study for the Mind: COSMOS-Mind. Contemp Clin Trials. 2019 Aug;83:57-63. doi: 10.1016/j.cct.2019.06.019. Epub 2019 Jul 2.
PMID: 31271875DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Espeland, PhD; Multiple Principal Investigator
- Organization
- Wake Forest University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Laura D Baker, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Mark A Espeland, PhD
Wake Forest University Health Sciences
- PRINCIPAL INVESTIGATOR
Stephen R Rapp, PhD
Co-Investigator Wake Forest School of Medicine
- PRINCIPAL INVESTIGATOR
Sally A Shumaker, PhD
Co-Investigator Wake Forest School of Medicine
- PRINCIPAL INVESTIGATOR
JoAnn E Manson, MD
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Howard Sesso, SCD, MPH
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 27, 2017
Study Start
September 1, 2016
Primary Completion
February 12, 2021
Study Completion
February 12, 2021
Last Updated
August 22, 2023
Results First Posted
August 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- after completion of study
- Access Criteria
- Data have been submitted to the parent COSMOS trial for merging with phenotypes and distribution.
COSMOS-Mind and COSMOS (parent trial, PI: Manson and Sesso) have data transfer procedures and protocols in place which use password protection and encryption, to permit seamless and secure exchange of information. Safety monitoring will be completed through the parent trial. The COSMOS-Mind staff will send all adverse events reported to them to the parent trial for reporting and follow-up. This data will be sent electronically only to approved users through a protected network.