Counseling for Cognitive Decline

(BHC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Other interventions, Exercise inability, Health concerns

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

95 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Brain Health Champion for cognitive decline?

Research shows that personalized programs combining cognitive exercises, diet changes, and mindfulness can improve cognitive function in older adults with mild cognitive impairment. A study found that 84% of participants experienced significant improvements in their cognitive abilities after a 12-week program similar to Brain Health Champion. ^{1 2 3 4 5}

Is the treatment Counseling for Cognitive Decline safe for humans?

The safety of treatments for brain health, including supplements like Ginkgo biloba, can be promising, but there are risks of interactions with other medications. It's important to discuss any supplements or treatments with a healthcare provider to avoid potential adverse effects. ^{6 7 8 9 10}

How is the Brain Health Champion treatment different from other treatments for cognitive decline?

The Brain Health Champion treatment is unique because it combines personalized cognitive stimulation, neurofeedback training, and lifestyle coaching, including diet and exercise, to improve cognitive function. This multi-disciplinary approach is different from standard treatments that may focus solely on medication or single interventions. ^{2 4 11 12 13}

What is the purpose of this trial?

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 health recommendations for patients with subjective cognitive decline, mild cognitive impairment, and early dementia or patients who are at risk for developing these conditions.

Research Team

Seth Gale

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am between 55 and 85 years old.

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

Exclusion Criteria

Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder

I cannot or do not want to exercise regularly.

Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized recommendations from a health coach or standard physician counseling over 6 months

6 months

Weekly motivational phone calls for the health coach arm; routine clinic visits for the control arm

Follow-up

Participants are monitored for maintenance of behaviors and outcomes 6 months post-intervention

6 months

Follow-up assessments and booster encounters

Treatment Details

Interventions

• Brain Health Champion

Trial Overview 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.

Participant Groups

Group I: Brain Health Champion (BHC) Experimental Treatment 1 Intervention

A "health coach" intervention with weekly phone calls

Group II: Standard of Care (SOC) Active Control 1 Intervention

The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

In a 12-week intervention trial involving 127 elderly patients with Mild Cognitive Impairment (MCI), 84% showed significant improvements in cognitive function after participating in a personalized Brain Fitness Program.

Among a subset of 17 patients who underwent MRI scans, 12 exhibited either no hippocampal atrophy or an increase in hippocampal volume, suggesting potential for reversing cognitive decline associated with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Personalized 12-week "Brain Fitness Program" for Improving Cognitive Function and Increasing the Volume of Hippocampus in Elderly with Mild Cognitive Impairment. Fotuhi, M., Lubinski, B., Trullinger, M., et al.[2022]

The pilot study involving 19 older adults with mild cognitive impairment (MCI) showed that combining cognitive training, mind-body exercise, and nurse-led risk factor modification (CPR) was feasible and had preliminary benefits, particularly in reducing cognitive decline and improving quality of life.

The nurse-led risk factor modification (RFM) group demonstrated significant improvements in cognitive scores, while the CPR group showed reductions in health service costs, indicating that both interventions could be effective strategies for managing MCI in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care. Xu, Z., Zhang, D., Lee, ATC., et al.[2022]

A review of 12 dietary supplements marketed for brain health revealed that 67% had ingredients listed on their labels that were not detected in the actual product, indicating potential misbranding.

Additionally, 83% of the products contained compounds that were not reported on the labels, and many scientific claims made by these products lacked scientific support, highlighting the need for consumer education and regulatory improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. Crawford, C., Boyd, C., Avula, B., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Educational interventions to improve detection and management of cognitive decline in primary care-An Italian multicenter pragmatic study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Personalized 12-week "Brain Fitness Program" for Improving Cognitive Function and Increasing the Volume of Hippocampus in Elderly with Mild Cognitive Impairment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Neuropsychologists as primary care providers of cognitive health: A novel comprehensive cognitive wellness service delivery model. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A pilot feasibility randomized controlled trial on combining mind-body physical exercise, cognitive training, and nurse-led risk factor modification to reduce cognitive decline among older adults with mild cognitive impairment in primary care. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol for a Mixed-Methods Process Evaluation of BetterBrains: A Person-Centered Online Intervention to Delay Cognitive Decline in Adults at Risk of Dementia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Beliefs about benefits and harms of medications and supplements for brain health. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Public Health Issue: Dietary Supplements Promoted for Brain Health and Cognitive Performance. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Primary prevention recommendations to reduce the risk of cognitive decline. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Perceptions of natural health products among patients attending a memory clinic. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

An update on drug interactions with the herbal medicine Ginkgo biloba. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Mild cognitive impairment in geriatric practice: patient orientation, diagnostics, treatment and ethics]. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Geriatrics in Clinical Practice and Beyond: Brain Health, the Sixth Vital Sign. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Efficacy of lifestyle and psychosocial interventions in reducing cognitive decline in older people: Systematic review. [2021]