Clinical trial NCT03035201: COcoa Supplement and Multivitamin Outcomes Study for the Mind
Official title: COcoa Supplement and Multivitamin Outcomes Study-Mind
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Dementia
Aging
Keywords: Memory
Mild Cognitive Impairment
Alzheimer's Disease
Cognition
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Brigham and Women's Hospital
First posted: 2017-01-27
Enrollment: 2262
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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 21,442 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.

After the COSMOS trial began, an advanced method to analyze cocoa flavanols was accredited by Association of Official Agricultural Chemists (AOAC) International as a First Action Official Method of Analysis https://doi.org/10.1093/jaoacint/qsaa132 \[secure-web.cisco.com\]). This updated method relies on a reference material (RM8403) recently standardized and made commercially available by the U.S. National Institute of Standards and Technology. While the actual cocoa flavanol content of the COSMOS intervention remained unchanged throughout the trial, the application of this new analytical method led to expected changes in how the total cocoa flavanol content is now reported. Applying AOAC 2020.05/RM8403 to the COSMOS intervention, the total cocoa flavanol content of the COSMOS intervention is now 500 mg/day. Reporting of (-)-epicatechin content remained unaffected. Going forward, this record will therefore apply AOAC 2020.05/RM8403 and report that the COSMOS intervention tested 500 mg/day of cocoa flavanols, including 80 mg of (-)-epicatechin.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global Cognitive Function: Average Change Over Follow-up From Baseline
timeFrame: From Baseline through Year 3
Secondary outcomes:
measure: Composite Cognitive Function
timeFrame: From baseline through year 3
measure: Incident Mild Cognitive Impairment
timeFrame: From baseline through year 3
measure: Incidence of Mild Cognitive Impairment Among Those Free at Baseline
timeFrame: From baseline through year 3
measure: Executive Function
timeFrame: From baseline through year 3
measure: Episodic Memory
timeFrame: From baseline through year 3
measure: Executive Function
timeFrame: From baseline through year 3
measure: Episodic Memory
timeFrame: From baseline through year 3
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Laura D Baker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Mark A Espeland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Investigator Wake Forest School of Medicine
name: Stephen R Rapp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Investigator Wake Forest School of Medicine
name: Sally A Shumaker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
name: JoAnn E Manson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
name: Howard Sesso, SCD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker 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.