Clinical trialNCT03035201CompletedObservational

COcoa Supplement and Multivitamin Outcomes Study for the Mind

SponsorWake Forest University Health SciencesEnrollment2,262AgingCognitive ImpairmentDementia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Howard Sesso, SCD, MPH
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Principal Investigator
clinicaltrials.gov ↗
JoAnn E Manson, MD
Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Principal Investigator
clinicaltrials.gov ↗
Laura D Baker, PhD
Wake Forest University Health Sciences
Principal Investigator
clinicaltrials.gov ↗
Mark A Espeland, PhD
Wake Forest University Health Sciences
Principal Investigator
clinicaltrials.gov ↗
Sally A Shumaker, PhD
Co-Investigator Wake Forest School of Medicine
Principal Investigator
clinicaltrials.gov ↗
Stephen R Rapp, PhD
Co-Investigator Wake Forest School of Medicine
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Wake Forest School of Medicine
Winston-Salem, North Carolina, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Sept 2016
Primary completion: 12 Feb 2021
Completion: 12 Feb 2021
Last update posted: 22 Aug 2023
Registered enrollment: 2,262
Registry id: NCT03035201

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.