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COcoa Supplement and Multivitamin Outcomes Study for the Mind (COSMOS-Mind)

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ClinicalTrials.gov Identifier: NCT03035201
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Brigham and Women's Hospital
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date January 20, 2017
First Posted Date January 27, 2017
Last Update Posted Date September 5, 2019
Study Start Date September 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2018)
  • Number of Participants that are not Hearing Impaired [ Time Frame: 4 years ]
    The number of participants that are not hearing impaired and can be administered the cognitive assessments will be recorded.
  • Cocoa extract effects on global cognitive trajectory [ Time Frame: 4 years ]
    A composite cognitive measure that combines individual test scores of global cognitive function (TICSm), memory (SR), and executive function (OTMT, Verbal Fluency, Number Span Test, DOT), which will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin). [Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
Original Primary Outcome Measures
 (submitted: January 25, 2017)
A composite measure that combines individual assessments of global cognitive function (TICSm), memory (SR), and executive function (OTMT, Verbal Fluency, Number Span Test, DOT) on those randomly assigned to daily cocoa extract compared to placebo. [ Time Frame: 3 Years ]
Random assignment to daily cocoa extract compared to placebo and favorable effects on a composite measure of cognitive function.
Change History Complete list of historical versions of study NCT03035201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 13, 2017)
  • Multivitamin effects on global cognitive trajectory [ Time Frame: 4 years ]
    A composite cognitive measure that combines individual test scores of global cognitive function (TICSm), memory (SR), and executive function (OTMT, Verbal Fluency, Number Span Test, DOT), which will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin). [Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
  • Treatment effects on incident cognitive impairment [ Time Frame: 4 years ]
    New cases of mild cognitive impairment, Alzheimer's disease or other dementias will be compared across treatment groups
  • Intervention effects on executive function and episodic memory [ Time Frame: 4 years ]
    Composite cognitive measures that combine individual test scores of executive function and of episodic memory will be compared across participants randomized to received daily cocoa extract (with and without co-administration of the the multivitamin) versus placebo (with and without co-administration of the multivitamin). [Time Frame: Total of 4 years: Baseline + 3 Years of follow-up]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COcoa Supplement and Multivitamin Outcomes Study for the Mind
Official Title COcoa Supplement and Multivitamin Outcomes Study-Mind
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 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.
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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Cognitive Impairment
  • Dementia
  • Aging
Intervention Not Provided
Study Groups/Cohorts
  • Cocoa extract + multivitamin
    2 capsules containing 750 mg/d cocoa extract; daily MTV
  • Cocoa extract + multivitamin placebo
    2 capsules containing 750 mg/d cocoa extract; daily MTV placebo
  • Cocoa extract placebo + multivitamin
    Cocoa extract placebo (2 capsules/d); daily MTV
  • Cocoa extract placebo + multivitamin placebo
    Cocoa extract placebo (2 capsules/d); daily MTV placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 13, 2018)
2262
Original Estimated Enrollment
 (submitted: January 25, 2017)
2000
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03035201
Other Study ID Numbers IRB00037753
1R01AG050657-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: COSMOS-Mind and COSMOS (parent trial, PI: Manson and Sesso) have data transfer procedures and protocols in place which use password protection and encryption, to permit seamless and secure exchange of information. Safety monitoring will be completed through the parent trial. The COSMOS-Mind staff will send all adverse events reported to them to the parent trial for reporting and follow-up. This data will be sent electronically only to approved users through a protected network.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: after completion of study
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators
  • National Institute on Aging (NIA)
  • Brigham and Women's Hospital
Investigators
Principal Investigator: Laura D Baker, PhD Wake Forest University Health Sciences
Principal Investigator: Mark A Espeland, PhD Wake Forest University Health Sciences
Principal Investigator: Stephen R Rapp, PhD Co-Investigator Wake Forest School of Medicine
Principal Investigator: Sally A Shumaker, PhD Co-Investigator Wake Forest School of Medicine
Principal Investigator: JoAnn E Manson, MD Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
Principal Investigator: Howard Sesso, SCD, MPH Parent Study Principal Investigator/COSMOS Mind Co-Investigator Brigham and Women's Hospital
PRS Account Wake Forest University Health Sciences
Verification Date September 2019