CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,262 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 3
  • Age 65 years or older
  • Willingness to participate in the study
  • Able to answer questions by phone
Key exclusion· 3
  • Co-enrolled in WHI Memory Study
  • Insulin-dependent diabetes
  • Unable to complete baseline cognitive assessments

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035201
NCT03035201N/ACompleted

COcoa Supplement and Multivitamin Outcomes Study-Mind

Wake Forest University Health Sciences·observational·Posted Jan 27, 2017·Updated Aug 22, 2023

In Brief

An observational study for Cognitive Impairment and 2 related conditions. Completed, enrolled 2,262 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 27, 2017
Enrollment StartSep 1, 2016
Primary CompletionFeb 12, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.4 years ago