Status:

ACTIVE_NOT_RECRUITING

The Brain Health Champion Study

Lead Sponsor:

Brigham and Women's Hospital

Conditions:

Mild Cognitive Impairment

Dementia, Mild

Eligibility:

All Genders

60-79 years

Phase:

NA

Brief Summary

6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalization compared to standard physician counseling on adherence to consensus-based, brain he...

Detailed Description

This is a 6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalized recommendations from a health coach, compared to standard physician counseli...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Be age 60 to 79
  • Existing patient at Brigham Health system with at least one prior visit with providers and plans to establish/continue longitudinal care
  • Be sufficiently fluent in the English language to understand instructions and perform the cognitive and functional tests
  • For neurology participants only: Have a diagnosis of Subjective Cognitive Disorder (SCD) (MMSE guideline 27-30), Mild Cognitive Impairment (MCI) due to Alzheimer disease (AD), cerebrovascular disease (CVD), or mixed-type AD/CVD (MMSE guideline 24-30), or mild dementia due to AD, CVD, or mixed-AD/CVD (MMSE guideline 20-30). In some cases, based on the clinical judgment of the treating neurologist, we may enroll a patient who falls outside of these guidelines or whose diagnosis and overall level of functioning does not perfectly correlate to their MMSE score.
  • For primary care participants only: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score of ≥ 6, or score of 5 plus one of the following: a history of ADRD in a first-degree relative, or type II diabetes or "pre-diabetes" spectrum (A1C level ≥ 5.7)
  • Exclusion criteria:
  • Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder
  • Be unable to or unwilling to carry out regular physical exercise, multiple times weekly.
  • Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.

Exclusion

    Key Trial Info

    Start Date :

    May 8 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2026

    Estimated Enrollment :

    95 Patients enrolled

    Trial Details

    Trial ID

    NCT03772977

    Start Date

    May 8 2017

    End Date

    June 1 2026

    Last Update

    November 21 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Brigham and Women's Hospital, Department of Neurology

    Boston, Massachusetts, United States, 02115

    The Brain Health Champion Study | DecenTrialz