Brain Health Program for Memory Loss

Overseen By Makenna Law

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Mild cognitive impairment, Dementia, Psychosis, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

60 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you've changed psychotropic medications in the last 3 months, you may not be eligible.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not have changed any psychotropic medications (like antidepressants) in the last 3 months.

What data supports the idea that Brain Health Program for Memory Loss is an effective treatment?

The available research shows that the Brain Health Program for Memory Loss is effective in improving memory in people with mild cognitive impairment (MCI). In a study, participants who underwent memory training showed better memory outcomes over 24 months compared to those who received health training. Another study on a similar program found that 84% of participants experienced significant improvements in their cognitive function after a 12-week program. These results suggest that the Brain Health Program can help maintain and improve memory in individuals with MCI. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment My Healthy Brain 2 for memory loss?

Research shows that a similar program, My Healthy Brain, which promotes a healthy lifestyle and cognitive strategies, was feasible and acceptable, suggesting potential benefits for brain health. Additionally, multi-domain interventions, like those in the MAPT study, have shown improvements in memory and cognitive functions in older adults at risk for dementia. ^{3 6 7 8 9}

What safety data is available for the Brain Health Program for Memory Loss?

The provided research does not contain any safety data related to the Brain Health Program for Memory Loss or its other names such as My Healthy Brain 1, Brain Health Program, Healthy Brain Initiative, My Healthy Brain 2, or MHB2. ^{10 11 12 13 14}

Is the Brain Health Program for Memory Loss safe for humans?

The available research does not provide specific safety data for the Brain Health Program for Memory Loss or its related names. However, it is important to be cautious with dietary supplements marketed for brain health, as some may have misleading labels and could pose risks. ^{6 8 15 16 17}

Is the treatment My Healthy Brain 1, My Healthy Brain 2 a promising treatment for memory loss?

Yes, My Healthy Brain 1 and My Healthy Brain 2 are promising treatments for memory loss. They focus on promoting a healthy lifestyle, including diet, exercise, and sleep, and help build cognitive reserve, which can improve memory and overall brain health. ^{3 6 8 18 19}

How is the Brain Health Program for Memory Loss treatment different from other treatments for memory loss?

The Brain Health Program for Memory Loss, using My Healthy Brain 1 and 2, is unique because it focuses on promoting a healthy lifestyle and building cognitive reserve through diet, exercise, and memory strategies, rather than relying solely on medication. This approach aims to improve overall brain health and prevent cognitive decline by encouraging sustainable healthy behaviors. ^{3 6 8 18 19}

What is the purpose of this trial?

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia. The primary aim of the study is to determine the credibility, expectancy, feasibility, acceptability, appropriateness, fidelity, and satisfaction of the programs.

Eligibility Criteria

This trial is for older adults who feel their memory or thinking skills are slipping (subjective cognitive decline), have a risk score for dementia of 6 or higher, can communicate in English, and can join live video sessions. They must be cleared by a doctor to participate and should not have significant functional impairments.

Inclusion Criteria

You need to score at least 28 on a test to check your thinking and memory skills over the phone.

You are able and willing to join the study through live video.

You are able to speak and read English fluently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week virtual lifestyle program focusing on brain health, with weekly 90-minute sessions via Zoom

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for improvements in cognition, lifestyle behaviors, and emotional well-being

6 months

1 visit (virtual)

Treatment Details

Interventions

• My Healthy Brain 1
• My Healthy Brain 2

Trial Overview The study compares two 'My Healthy Brain' programs designed to support brain health and possibly reduce the risk of dementia. The goal is to evaluate how believable, expected, doable, acceptable, suitable these programs are and how satisfied participants are with them.

Participant Groups

Group I: My Healthy Brain 1 Experimental Treatment 1 Intervention

My Healthy Brain 1 is an 8-week group program delivered via 90-minute Zoom meetings led by a clinical psychologist. It provides education on the link between dementia and lifestyle factors, including poor exercise, sleep, diet/nutrition, mental and social stimulation, alcohol, and smoking. My Healthy Brain 1 participants learn evidence-based mindfulness and behavior change skills to address common barriers to healthy habits, such as stress and setting achievable goals. My Healthy Brain 1 participants wear an activity watch to monitor lifestyle changes during the program.

Group II: My Healthy Brain 2 Active Control 1 Intervention

My Healthy Brain 2 condition controls for the effect of time spent and support/feedback from the group and interventionist. Participants in My Healthy Brain 2 will receive education on lifestyle, brain health, and cognitive decline symptoms in addition to usual care as determined by their medical team. Each weekly session will focus on a different topic: 1) lifestyle and brain health, 2) physical activity, 3) sleep, 4) nutrition, 5) medical adherence, 6) cognitive health, 7) social support, and 8) a program overview. My Healthy Brain 2 is conducted in the same format as My Healthy Brain 1 (8 weekly Zoom sessions, 90 minutes each), but does not include behavior change strategies. My Healthy Brain 2 participants wear an activity watch to monitor lifestyle changes during the program.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

Patients with various diagnoses, including brain injury, stroke, and other neurological conditions, showed significant improvements in memory performance after undergoing a strategy-based memory rehabilitation intervention, regardless of the severity of their memory impairment.

The study found that the improvements in memory were not due to practice effects or spontaneous recovery, indicating that the cognitive rehabilitation approach was effective across different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecologically-oriented neurorehabilitation of memory: robustness of outcome across diagnosis and severity. Stringer, AY., Small, SK.[2016]

In a pilot study involving 39 participants with mild cognitive impairment (MCI), those who underwent memory training showed significant improvements in both objective and subjective memory outcomes over a 24-month period compared to those who received health training.

The results suggest that the Senior WISE Memory training can effectively slow cognitive decline in individuals with MCI, maintaining benefits in memory function for up to two years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory training for adults with probable mild cognitive impairment: a pilot study. McDougall, GJ., McDonough, IM., LaRocca, M.[2021]

The memory rehabilitation program led to meaningful functional gains in all 12 patients with severe traumatic brain injury, indicating its effectiveness in improving daily living skills.

While some modest improvements were noted in memory tests like the California Verbal Learning Test, these did not correlate with the functional gains, suggesting that the program may enhance independence through compensatory strategies rather than direct memory improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of memory rehabilitation in traumatic brain injury assessed by neuropsychological tests and questionnaires. Quemada, JI., Muñoz Céspedes, JM., Ezkerra, J., et al.[2019]

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 My Healthy Brain (MHB) program, tested on 24 older adults with cognitive decline, showed good feasibility and acceptability, with 100% participant satisfaction and no reported adverse events.

Participants demonstrated improvements in lifestyle behaviors and subjective well-being after the 8-week program, indicating MHB's potential effectiveness in promoting healthier lifestyles to combat cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Healthy Brain: a multimodal lifestyle program to promote brain health. Mace, RA., Greenberg, J., Stauder, M., et al.[2022]

The Maintain Your Brain (MYB) trial is testing a digital health intervention designed to combat cognitive decline and potentially prevent dementia by targeting modifiable risk factors through behavioral modules and a new Brain Training System (BTS).

The BTS focuses on user engagement and adherence by providing personalized cognitive training, real-time feedback, and social support, with the pilot trial involving 100 participants completed in early 2018 and the main trial launched in June 2018.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Development of the Brain Training System for the Digital "Maintain Your Brain" Dementia Prevention Trial. Walton, CC., Lampit, A., Boulamatsis, C., et al.[2020]

The MEND+ program, which integrates medical visits into a childhood obesity intervention, led to significant decreases in body mass index (BMI) percentiles and blood pressure among 347 participants aged 4 to 17 years, demonstrating its effectiveness in a community health setting.

After attending the MEND+ program, participants experienced a decrease in BMI percentile by 0.087 units per month and reductions in systolic and diastolic blood pressure, while nonattendees showed increases in these measures, highlighting the program's positive impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body Mass Index and Blood Pressure Improvements With a Pediatric Weight Management Intervention at Federally Qualified Health Centers. Imoisili, OE., Lundeen, EA., Freedman, DS., et al.[2021]

A web-based multimedia health promotion program significantly reduced stress among 309 working adults compared to a control group, demonstrating its effectiveness in a workplace setting.

Participants in the web-based program also showed increased knowledge about depression and anxiety, improved attitudes toward treatment, and healthier alcohol consumption habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A web-based approach to managing stress and mood disorders in the workforce. Billings, DW., Cook, RF., Hendrickson, A., et al.[2021]

Among 220 small- and medium-sized employers participating in an insurer-sponsored wellness grant program, at least half reported some level of integration between occupational safety and health (OSH) and workplace wellness programs.

While meaningful integration was not widespread, many employers considered safety factors like ergonomics and substance exposure when designing their wellness programs, indicating a growing awareness of the connection between workplace safety and employee wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Degree of Integration Between Occupational Safety and Health Programs and Wellness Programs: First-year Results From an Insurer-Sponsored Wellness Grant for Smaller Employers. Meyers, AR., Al-Tarawneh, IS., Bushnell, PT., et al.[2022]

The My Health Matters! program successfully engaged 43% of employees in health risk assessments and identified metabolic syndrome risk factors in over half of those who attended clinical visits, leading to a significant 15% reduction in risk factors over six months.

The program was well-received, with 82% of participants recommending it to other employers, demonstrating its feasibility and value as a workplace intervention for managing metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). Tarride, JE., Harrington, K., Balfour, R., et al.[2017]

The health education program significantly improved cardiovascular health markers in first-grade children, with Jewish children showing increased high-density lipoproteins and both Jewish and Arab children showing decreased total cholesterol and body mass index after 2 years.

These findings suggest that even a short-term health education intervention can lead to meaningful changes in risk factors for cardiovascular disease among young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention of cardiovascular diseases in childhood: changes in serum total cholesterol, high density lipoprotein, and body mass index after 2 years of intervention in Jerusalem schoolchildren age 7-9 years. Tamir, D., Feurstein, A., Brunner, S., et al.[2019]

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]

In a randomized, double-blind, placebo-controlled trial involving 98 older adults with subjective memory complaints, BrainPower Advanced, a dietary supplement, showed significant improvement in memory loss and attention deficits after 12 weeks of supplementation.

The supplement was particularly effective, with 29.5% of participants experiencing improvement in severe memory loss and 34.9% in attention deficits, compared to much lower improvement rates in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial. Zhu, J., Shi, R., Chen, S., et al.[2023]

The Memory Support System (MSS) was successfully learned and utilized by 20 participants with amnestic mild cognitive impairment (MCI), with 95% compliance at the end of training and 89% at follow-up.

Participants showed a medium effect size in improved functional ability, along with reported benefits in independence, self-confidence, and mood, indicating that the MSS may effectively help manage memory loss symptoms in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Greenaway, MC., Hanna, SM., Lepore, SW., et al.[2022]

References

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

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ecologically-oriented neurorehabilitation of memory: robustness of outcome across diagnosis and severity. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Memory training for adults with probable mild cognitive impairment: a pilot study. [2021]

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

Outcome of memory rehabilitation in traumatic brain injury assessed by neuropsychological tests and questionnaires. [2019]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

My Healthy Brain: a multimodal lifestyle program to promote brain health. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adaptation and virtual feasibility pilot of a mindfulness-based lifestyle program targeting modifiable dementia risk factors in older adults. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Design and Development of the Brain Training System for the Digital "Maintain Your Brain" Dementia Prevention Trial. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a 3-Year Multi-Domain Intervention with or without Omega-3 Supplementation on Cognitive Functions in Older Subjects with Increased CAIDE Dementia Scores. [2019]

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

Body Mass Index and Blood Pressure Improvements With a Pediatric Weight Management Intervention at Federally Qualified Health Centers. [2021]

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

A web-based approach to managing stress and mood disorders in the workforce. [2021]

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

Degree of Integration Between Occupational Safety and Health Programs and Wellness Programs: First-year Results From an Insurer-Sponsored Wellness Grant for Smaller Employers. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada). [2017]

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

Primary prevention of cardiovascular diseases in childhood: changes in serum total cholesterol, high density lipoprotein, and body mass index after 2 years of intervention in Jerusalem schoolchildren age 7-9 years. [2019]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline Among Community Dwelling 55 to 77 Year Olds. [2023]

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

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

17. Netherlands pubmed.ncbi.nlm.nih.gov

Factors Associated with Participation in a Multidomain Web-Based Dementia Prevention Trial: Evidence from Maintain Your Brain (MYB). [2023]

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

The Relieving Effects of BrainPower Advanced, a Dietary Supplement, in Older Adults with Subjective Memory Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial. [2023]

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

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. [2022]