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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two brain health programs designed to assist older adults with memory concerns and lifestyle risk factors that might lead to dementia. Participants will engage in 8-week programs via Zoom, focusing on lifestyle changes and brain health education. My Healthy Brain 1 emphasizes mindfulness and behavior change strategies, while My Healthy Brain 2 focuses on educational sessions without behavior change techniques. Individuals concerned about memory or thinking and willing to participate in online sessions might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research on brain health and lifestyle interventions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in the Brain Health Program for Memory Loss are generally safe for participants. Both My Healthy Brain 1 and My Healthy Brain 2 offer education and group sessions about lifestyle changes that can improve brain health.

Studies have found that programs focusing on lifestyle improvements, such as exercise, diet, and mental activities, are usually easy for people to handle. No reports of serious side effects have emerged from joining these types of programs. Participants in similar studies found these educational sessions and activities helpful and supportive.

In short, the treatments rely on well-known methods that promote healthy lifestyle habits, which are safe and beneficial for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain Health Program for Memory Loss because it offers a fresh approach to managing memory issues by focusing on lifestyle changes and education. Unlike conventional treatments that often emphasize medication, this program provides group-based learning via Zoom, teaching participants how lifestyle factors like exercise, sleep, and nutrition can influence brain health. My Healthy Brain 1 stands out by incorporating mindfulness and behavior change strategies, helping participants overcome common barriers to healthy habits. Both My Healthy Brain 1 and 2 include the use of activity watches to track lifestyle changes, which adds a practical, real-world element to monitoring progress. This innovative approach could empower individuals to take control of their brain health in a comprehensive, personalized way.

What evidence suggests that this trial's programs could be effective for memory loss?

Research has shown that lifestyle changes can help maintain brain health and slow memory loss. In this trial, participants will join one of two programs. The My Healthy Brain 1 program, one of the study arms, teaches skills such as mindfulness and behavior change. Studies have found that these skills can reduce stress and promote healthier choices, which are linked to improved brain health.

The My Healthy Brain 2 program, another study arm, provides information on lifestyle and brain health. Evidence suggests that learning about healthy habits like sleep, exercise, and nutrition can support brain health. Both programs in this trial aim to improve memory and brain function by encouraging healthy living. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

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]

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]

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]

Citations

1.

cdc.gov

cdc.gov/aging-programs/media/pdfs/2024/06/TheHealthyBrainInitiative_MaintainingCognitiveHealth.pdf

The Healthy Brain Initiative

Although not all people with cognitive decline develop dementia, those with an amnestic form of mild cognitive impairment do have a much higher risk for ...

2.

alz.org

alz.org/professionals/public-health/models-frameworks/hbi-road-map

Healthy Brain Initiative (HBI) Road Map

The Healthy Brain Initiative (HBI) Road Map framework helps public health professionals lead communities to improve brain health and support caregivers.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05934136

NCT05934136 | Brain Health Program for Older Adults with ...

The investigators will compare two brain health programs in older adults with subjective cognitive decline and lifestyle risk factors for dementia.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10610524/

The Healthy Brain Initiative (HBI): A prospective cohort study ...

The HBI is a longitudinal, observational cohort study that will prospectively collect, analyze, maintain, and store clinical, cognitive, ...

5.

umiamibrainhealth.org

umiamibrainhealth.org/hbi-study/

Healthy Brain Initiative (HBI) Study

This project aims to develop a dementia prevention initiative using a precision medicine approach with personalized tailored interventions in deeply phenotype ...

6.

cdc.gov

cdc.gov/aging-programs/media/pdfs/2024/Ensuring-Early-Detection-and-Diagnosis-A-Healthy-Brain-Initiative-Issue-Map.pdf

Ensuring Early Detection and Diagnosis

» Nearly 1 in 4 people with dementia has a preventable hospitalization.6. Some adults may experience changes in the brain that lead to cognitive decline. Mild ...