COcoa Supplement and Multivitamin Outcomes Study for the Mind
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Healthy Studies, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 9/21/2018 |
| Start Date: | September 2016 |
| End Date: | October 2020 |
COcoa Supplement and Multivitamin Outcomes Study-Mind
The parent trial (COcoa Supplement and Multivitamin Outcomes Study, COSMOS; NCT02422745) is a
randomized clinical trial of cocoa extract supplement (containing a total of 600 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 AD and other related types of dementia.
Participants at the Wake Forest site will only be getting a phone call.
randomized clinical trial of cocoa extract supplement (containing a total of 600 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 AD and other related types of dementia.
Participants at the Wake Forest site will only be getting a phone call.
Identifying a safe, affordable, and well-tolerated intervention that prevents cognitive
decline in older adults is of critical public health importance. 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.
The parent trial (COSMOS) 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 to assess whether
high-potency cocoa flavanol extract and a multivitamin - alone or in combination - will
reduce risk of cardiovascular disease and cancer over 3 years of follow-up.
Once participants are enrolled in COSMOS, the study team at Brigham and Women's Hospital will
provide contact information and other parent trial outcomes for COSMOS-Mind participants to
the Wake Forest team using a secure web-based data transfer system. This seamless exchange of
information between sites will permit timely accounting to ensure that the targeted
demographics for enrollment are achieved (e.g. gender, age, race, ethnicity).
COSMOS-Mind will only be administered a telephone cognitive assessment to all participants at
enrollment (baseline), and annually for 3 years of follow-up by trained and certified staff
of the Wake Forest COSMOS-Mind team.
decline in older adults is of critical public health importance. 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.
The parent trial (COSMOS) 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 to assess whether
high-potency cocoa flavanol extract and a multivitamin - alone or in combination - will
reduce risk of cardiovascular disease and cancer over 3 years of follow-up.
Once participants are enrolled in COSMOS, the study team at Brigham and Women's Hospital will
provide contact information and other parent trial outcomes for COSMOS-Mind participants to
the Wake Forest team using a secure web-based data transfer system. This seamless exchange of
information between sites will permit timely accounting to ensure that the targeted
demographics for enrollment are achieved (e.g. gender, age, race, ethnicity).
COSMOS-Mind will only be administered a telephone cognitive assessment to all participants at
enrollment (baseline), and annually for 3 years of follow-up by trained and certified staff
of the Wake Forest COSMOS-Mind team.
Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to
participate in this ancillary study:
Inclusion Criteria -
1. Men and women 65 years and older.
2. Willingness to participate.
3. Ability to answer questions by phone.
Exclusion Criteria -
1. Participants who are co-enrolled in the WHI Memory Study.
2. Participants with insulin-dependent diabetes.
3. Participants who are unable to complete the baseline cognitive assessments.
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