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Counseling for Cognitive Decline (BHC Trial)

N/A
Waitlist Available
Led By Seth A Gale, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be age 55 to 85
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)
Must not have
Be unable to or unwilling to carry out regular physical exercise, multiple times weekly.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will compare the effects of two types of counseling on adherence to brain health recommendations for people with early dementia or at risk for developing it.

Who is the study for?
This trial is for adults aged 55 to 85 who are patients at Brigham Health system, fluent in English, and have cognitive issues like mild dementia or are at risk. Neurology patients must have specific diagnoses with certain MMSE scores, while primary care participants need a high CAIDE score or diabetes.
What is being tested?
The study tests the 'Brain Health Champion' program over six months. It compares personalized clinical contact and advice on brain health against standard counseling for people with cognitive decline or those at risk of developing such conditions.
What are the potential side effects?
Since this trial involves increased clinical contact and personalization rather than medication, typical drug side effects aren't expected. However, there may be indirect effects related to changes in lifestyle or stress due to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
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I have a high risk of dementia based on my CAIDE score and health history.
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I am between 60 and 79 years old.
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I have a high risk of dementia based on my CAIDE score and health history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot or do not want to exercise regularly.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Self-report adherence to Mediterranean diet
Self-report exercise and physical activity
Self-report participation in cognitive and socially stimulating activities
Secondary study objectives
Cognitive function
Neuropsychiatric status
Quality of Life Self-Report
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brain Health Champion (BHC)Experimental Treatment1 Intervention
A "health coach" intervention with weekly phone calls
Group II: Standard of Care (SOC)Active Control1 Intervention
The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,940 Total Patients Enrolled
Seth A Gale, MDPrincipal InvestigatorBrigham and Women's Hospital
~11 spots leftby Sep 2025
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