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Brain Health Champion for Mild Cognitive Impairment (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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

BHC Trial 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.Check my eligibility

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.See study design

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.

BHC Trial 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.

BHC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self-report adherence to Mediterranean diet

Self-report exercise and physical activity

Self-report participation in cognitive and socially stimulating activities

Secondary outcome measures

Cognitive function

Neuropsychiatric status

Quality of Life Self-Report

+1 more

BHC 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,469,782 Total Patients Enrolled

Seth A Gale, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently seeking participants?

"According to the clinicaltrials.gov page, this medical trial is not longer accepting candidates -- it was initially posted on May 8th 2017 and last updated March 8th 2022. However, there are a plethora of other trials that still require participants at this time; 890 in total."

Answered by AI

Does this trial accept participants aged 55 and above?

"The age range for those eligible to participate in this medical trial is from 55 years old up until 85."

Answered by AI

Who meets the criteria for participating in this trial?

"This clinical trial is seeking 85 participants with dementia between the ages of fifty-five and eighty-five. Key conditions for enrollment include: being able to comprehend instructions in English, having established or continuing care at Brigham Health system, meeting MMSE guidelines depending on diagnosis (27-30 for SCD, 24-30 for MCI due to AD/CVD, 20-30 for mild dementia), CAIDE risk score ≥ 6 accompanied by a history of ADRD or pre-diabetes if scoring 5."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Brain Health Champion Study

Seth Gale 2017. "The Brain Health Champion Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03772977.

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