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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met