N/A
Completed N=2,262
COcoa Supplement and Multivitamin Outcomes Study for the Mind
Source: ClinicalTrials.gov NCT03035201 ↗Enrolled (actual)
2,262
Serious AEs
—
Results posted
Aug 2023
Primary outcomePrimary: Global Cognitive Function: Average Change Over Follow-up From Baseline — 0.24; 0.15; 0.20; 0.15 score on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Cognitive Function: Average Change Over Follow-up From Baseline |
0.24; 0.15; 0.20; 0.15 | <0.05 sig |
| SECONDARY Composite Cognitive Function |
0.24; 0.15; 0.20; 0.15 | <0.05 sig |
| SECONDARY Incident Mild Cognitive Impairment |
47; 63 | 0.15 |
| SECONDARY Incidence of Mild Cognitive Impairment Among Those Free at Baseline |
53; 57 | 0.62 |
| SECONDARY Executive Function |
0.08; 0.02 | 0.02 sig |
| SECONDARY Episodic Memory |
0.31; 0.25 | 0.04 sig |
Eligibility Criteria
Participants in COSMOS (NCT02422745) who meet the following criteria are eligible to participate in this ancillary study:
Inclusion Criteria -
- Men and women 65 years and older.
- Willingness to participate.
- Ability to answer questions by phone.
Exclusion Criteria -
- 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.
Data sourced from ClinicalTrials.gov (NCT03035201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.