Lifestyle Interventions for Dementia Prevention

(DDPP Trial)

Overseen By David K Johnson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Psychoactive medications, Opiate analgesics

Disqualifiers: Neurologic disease, Major depression, Bipolar, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 24

Duration: 32 weeks

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using certain psychoactive medications, like tricyclic antidepressants and antipsychotics, within the last 3 months. However, stable doses of some antidepressants like SSRIs and SNRIs are allowed.

What data supports the effectiveness of the treatment involving lifestyle interventions for dementia prevention?

Research suggests that the MIND diet, which combines elements of the Mediterranean and DASH diets, is linked to better cognitive function and a lower risk of Alzheimer's disease. Additionally, combining physical activity with the MIND diet may help slow the onset of dementia. ^{1 2 3 4 5}

Is the MIND diet safe for humans?

The MIND diet, which combines elements of the Mediterranean and DASH diets, has been associated with various health benefits, including better cognitive performance and reduced risk of cardiovascular diseases, without any reported safety concerns in humans. ^{4 6 7 8 9}

How is the Lifestyle Interventions for Dementia Prevention treatment different from other treatments for dementia?

This treatment is unique because it combines aerobic exercise and the MIND diet, which focuses on eating more vegetables, berries, nuts, and fish while reducing meat and sugar intake, to potentially slow the onset of dementia. Unlike drug treatments, this approach targets lifestyle changes, which are modifiable risk factors for dementia. ^{2 10 11 12 13}

What is the purpose of this trial?

This is a multicenter, randomized 2-arm clinical trial of two lifestyle interventions varying in intensity and format, in 400 older African American and non-Hispanic whites at increased risk of cognitive decline and dementia in the East San Francisco Bay Area. The trial will include two lifestyle interventions that differ in intensity and format: 1. Aerobic Exercise (AEx) Intervention that involves aerobic activities with in-class walking workouts and tutorials and carried out at the East Oakland Sports Center (EOSC) and Tice Creek Fitness Center (TICE). 2. Dietary counseling to support adherence to the Mediterranean-Diet Approaches to Stop Hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet to encourage increased consumption of berries, green leafy and other vegetables, whole grains, nuts, fish, poultry, beans and olive oil, and to reduce consumption of fried/fast foods, red meat, whole fat cheese, sweets, butter and trans-fat margarines.

Research Team

David K Johnson, PhD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for older African Americans and non-Hispanic whites at risk of cognitive decline, who are sedentary with a poor diet but without significant cognitive impairment or physical disabilities. Participants must not plan extensive travel during the study and be willing to join either lifestyle intervention group.

Inclusion Criteria

I am willing to follow a new lifestyle plan as part of the study.

Lives in a region where the DDPP interventions will be delivered

I will not travel outside my local area for more than 3 months during the study.

Exclusion Criteria

I haven't had treatment for cancer, except for certain skin or early stage cancers, in the last 2 years.

I have had weight loss surgery that affects how my body absorbs food.

I have not been diagnosed with major depression in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-month lifestyle intervention program including aerobic exercise and dietary counseling

32 weeks

Weekly visits for 20 weeks, then flexible scheduling

Follow-up

Participants are monitored for changes in fitness and cognitive performance

4 months

Follow-up visits at Month 4

Treatment Details

Interventions

• Aerobic Exercise
• Diet Skills

Trial Overview The trial tests two interventions: an Aerobic Exercise program with in-class walking workouts, and dietary counseling based on the MIND diet aimed at improving brain health by eating more berries, vegetables, grains, nuts, fish, poultry, beans and olive oil while reducing unhealthy fats and red meat.

Participant Groups

Group I: Aerobic Exercise Group Active Control 1 Intervention

Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise will vary, but will primarily focus on in-class walking tutorials. Participants will work with a Personal Trainer to create their own physical activity program that will fit their needs and schedule. The Personal Trainer will supervise the participants directly for the first 6 weeks. Once participants are consistently and safely meeting their goals, their Personal Trainer will allow unsupervised exercise sessions.

Group II: Diet Skills Group Active Control 1 Intervention

Participants will attend weekly classes focused on incorporating heart healthy foods (e.g., fruits and vegetables) into their existing dietary plan. We will ask them to limit the number of calories they take in and will show them how to use portion control with the goal of losing body weight. Participants will also learn hands-on skills for preparing healthy meals at home in cooking classes led by professional chefs.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Tice Creek Fitness Center

Collaborator

Trials

1

Recruited

400+

East Oakland Sports Center

Collaborator

Trials

1

Recruited

400+

Findings from Research

The MIND diet shows promise as a long-term treatment option for improving cognitive function in individuals with various forms of dementia, based on a systematic review of 11 studies involving different dementia pathologies.

All studies reviewed indicated a positive correlation between adherence to the MIND diet and cognitive functioning, although the effects on specific cognitive domains varied, highlighting the need for further research to understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the MIND Diet on Cognition in Individuals with Dementia. Healy, E.[2023]

A study involving 3463 participants aged around 68 years found that combining high-intensity physical activity with the MIND diet significantly improved global cognition and reduced the odds of cognitive decline compared to not following either behavior.

While the MIND diet alone also showed benefits for cognition, the combination of both high-intensity physical activity and the MIND diet provided the most substantial cognitive health advantages, suggesting that promoting both lifestyle changes could be beneficial in preventing dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of adherence to high-intensity physical activity and the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet with cognition: A cross-sectional study. Ahn, S., Lingerfelt, CN., Lee, CE., et al.[2022]

In a 3-year randomized controlled trial involving 604 older adults at risk for dementia, the MIND diet did not show significant cognitive benefits compared to a control diet, with only a slight improvement in global cognition scores for the MIND diet group.

MRI results indicated no significant differences in brain characteristics, such as white-matter hyperintensities and hippocampal volumes, between participants following the MIND diet and those on the control diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. Barnes, LL., Dhana, K., Liu, X., et al.[2023]

Higher adherence to the Mediterranean diet is linked to better cognitive function and a lower risk of Alzheimer's disease (AD), supported by evidence from 9 of 12 cross-sectional studies and 6 of 8 longitudinal studies.

The MIND diet shows the strongest association with reduced cognitive decline and lower AD risk, with positive results in 2 of 3 longitudinal studies, indicating that these dietary patterns may serve as effective preventive strategies against dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diets Are Associated with Less Cognitive Decline and a Lower Risk of Alzheimer's Disease-A Review. van den Brink, AC., Brouwer-Brolsma, EM., Berendsen, AAM., et al.[2023]

The My Healthy Brain program, an 8-week group-based lifestyle intervention delivered via live video, effectively targets multiple lifestyle risk factors for dementia in older adults with cognitive decline or mild cognitive impairment.

Participants reported that the program was feasible and acceptable, suggesting it has the potential to improve lifestyle, cognitive, and psychosocial outcomes for at-risk older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. Mace, RA., Hopkins, SW., Reynolds, GO., et al.[2023]

In a study of 943 patients with atherosclerotic cardiovascular disease (ASCVD) or stroke, those who adhered more closely to the MIND diet had a significantly lower risk of all-cause and cardiovascular (CV) death compared to those with lower adherence.

For each one-point increase in MIND diet score, there was a 10% reduction in all-cause mortality risk and a 16% reduction in CV mortality risk, highlighting the potential benefits of the MIND diet for improving health outcomes in patients with ASCVD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better adherence to the MIND diet is associated with lower risk of all-cause death and cardiovascular death in patients with atherosclerotic cardiovascular disease or stroke: a cohort study from NHANES analysis. Song, Y., Chang, Z., Jia, L., et al.[2023]

Adherence to the MIND diet is associated with a significantly reduced risk of developing multiple sclerosis (MS), with an adjusted odds ratio of 0.10, indicating a strong protective effect based on a study of 77 patients with relapsing-remitting MS and 148 healthy controls.

Specific components of the MIND diet, such as high consumption of green leafy vegetables, other vegetables, and beans, are linked to lower odds of MS, while higher intake of unhealthy foods like pastries, sweets, and fried foods is associated with increased odds of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. Noormohammadi, M., Ghorbani, Z., Naser Moghadasi, A., et al.[2022]

The MIND diet is associated with improvements in various cardiometabolic outcomes, including better blood pressure, glycemic control, and lipid profiles, based on a systematic review of 23 studies involving adults.

The evidence supports the MIND diet as a beneficial strategy for reducing cardiometabolic risk, although more long-term and well-designed studies are needed to confirm its effects on cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of the MIND Diet with Cardiometabolic Diseases and Their Risk Factors: A Systematic Review. Akbar, Z., Fituri, S., Ouagueni, A., et al.[2023]

In a study of 339 individuals with obesity, those who adhered more closely to the MIND diet showed lower levels of stress and higher insulin sensitivity, suggesting potential mental health and metabolic benefits.

The highest MIND diet scores were linked to increased intake of brain-healthy foods and a significant reduction in the consumption of unhealthy sweets and pastries, indicating a positive dietary shift.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. Ardekani, AM., Vahdat, S., Hojati, A., et al.[2023]

Engaging in moderate physical activity can improve cognitive function and may lower the risk of developing dementia, highlighting the importance of an active lifestyle for older adults.

While nutritional supplements may help with deficiencies, they are not recommended for enhancing cognitive performance beyond a healthy diet, indicating that a balanced diet is crucial for brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle change and the prevention of cognitive decline and dementia: what is the evidence? Lövdén, M., Xu, W., Wang, HX.[2018]

In a study of 1,412 French older adults followed for nearly 10 years, higher adherence to a French-adapted MIND diet was linked to a significantly lower risk of developing dementia and Alzheimer's disease, suggesting its potential as a preventive strategy.

The study also found that a higher MIND diet score was associated with better white matter microstructure, as indicated by lower diffusivity values in the brain, although it did not show a significant impact on gray matter volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of a MIND Diet with Brain Structure and Dementia in a French Population. Thomas, A., Lefèvre-Arbogast, S., Féart, C., et al.[2022]

There is a strong consensus in the literature on the importance of preventive lifestyle measures to reduce the risk of developing dementia and Alzheimer's disease, but creating effective guidelines is challenging due to a lack of comparable randomized controlled trials.

Health professionals are urged to focus on early diagnosis of cognitive impairment and to implement strategies to manage vascular health and promote healthy lifestyle habits, as these are modifiable risk factors for dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief update on dementia prevention. Polidori, MC., Pientka, L.[2021]

The Virtual Cognitive Health study aims to validate the effectiveness of a yearlong internet-delivered lifestyle intervention for older adults (aged 60-75) with subjective memory decline, focusing on improving cognitive function, mental health, and lifestyle behaviors.

With 82 participants enrolled, the study will assess changes in cognitive function and mental health over time, providing crucial evidence for the scalability of remote interventions in preventing or delaying Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. Bott, N., Kumar, S., Krebs, C., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of the MIND Diet on Cognition in Individuals with Dementia. [2023]

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

Association of adherence to high-intensity physical activity and the Mediterranean-dietary approaches to stop hypertension intervention for neurodegenerative delay diet with cognition: A cross-sectional study. [2022]

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

Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. [2023]

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

The Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diets Are Associated with Less Cognitive Decline and a Lower Risk of Alzheimer's Disease-A Review. [2023]

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

My Healthy Brain: Rationale and Case Report of a Virtual Group Lifestyle Program Targeting Modifiable Risk Factors for Dementia. [2023]

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

Better adherence to the MIND diet is associated with lower risk of all-cause death and cardiovascular death in patients with atherosclerotic cardiovascular disease or stroke: a cohort study from NHANES analysis. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

MIND Diet Adherence Might be Associated with a Reduced Odds of Multiple Sclerosis: Results from a Case-Control Study. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Associations of the MIND Diet with Cardiometabolic Diseases and Their Risk Factors: A Systematic Review. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evaluating the association between the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, mental health, and cardio-metabolic risk factors among individuals with obesity. [2023]

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

Lifestyle change and the prevention of cognitive decline and dementia: what is the evidence? [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Association of a MIND Diet with Brain Structure and Dementia in a French Population. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

A brief update on dementia prevention. [2021]

13. Canada pubmed.ncbi.nlm.nih.gov

A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive Health (VC Health) Study. [2020]