Lifestyle Intervention for Dementia Prevention

(INSPIRE Trial)

Overseen By Dean Sherzai, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Healthy Minds Initiative

Disqualifiers: Dementia, Cancer, Pregnancy, Schizophrenia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

2000 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 study coordinators to understand any specific requirements.

What data supports the effectiveness of the treatment Lifestyle Intervention for Dementia Prevention?

Research suggests that lifestyle changes, such as improving diet, increasing physical activity, and engaging in social and cognitive activities, can help reduce the risk of developing dementia. These interventions target multiple risk factors and have shown promise in improving brain health and quality of life in older adults. ^{1 2 3 4 5}

Is the lifestyle intervention for dementia prevention safe for humans?

Lifestyle interventions, such as increasing physical activity and stopping smoking, are generally safe and have additional health benefits. Other interventions like social engagement and cognitive stimulation also appear promising with few risks, although more research is needed to confirm their safety. ^{1 2 4 6 7}

How is the Lifestyle Intervention treatment for dementia prevention different from other treatments?

The Lifestyle Intervention treatment is unique because it focuses on modifying lifestyle factors like diet, physical activity, and social engagement to prevent dementia, rather than using medication. This approach targets multiple risk factors simultaneously, offering a non-drug alternative that leverages healthy habits to potentially reduce the risk of cognitive decline. ^{1 2 4 8 9}

What is the purpose of this trial?

The INSPIRE Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Conducted in collaboration with the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center, this study focuses on African American communities that are disproportionately affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to directly address these disparities by implementing targeted interventions to enhance cognitive function and overall brain health.

Research Team

Dean Sherzai, MD, PhD

Principal Investigator

Healthy Minds Initiative

Eligibility Criteria

The INSPIRE Study is for African American individuals aged 55 or older, focusing on those at risk of cognitive decline. It aims to improve brain health and prevent dementia through lifestyle changes. Participants should be willing to engage in either a lifestyle intervention program or receive standard health education.

Inclusion Criteria

Ethnicity: Focused on African American individuals, but not exclusive.

Language: Participants must be fluent in English.

Location: Must reside in the Crenshaw, California area or be able to attend study-related activities in this location.

Exclusion Criteria

I don't have severe mobility issues that would stop me from joining in lifestyle changes.

Pregnancy: Current pregnancy or planning to become pregnant during the study period.

Mental Health: Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder that might interfere with participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Comprehensive initial assessment including evaluations of medical history, cognitive function, lifestyle habits, and access to health resources

1-2 weeks

1 visit (in-person)

Intervention

Participants receive personalized guidance from health coaches, participate in an online community forum, and have access to tailored exercise programs and educational materials

12 months

Monthly evaluations (virtual/in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations of cognitive health and lifestyle adherence

24 months

Periodic evaluations at 6 months, 1 year, and 3 years

Treatment Details

Interventions

• Lifestyle Intervention

Trial Overview This study tests the effectiveness of a lifestyle intervention against standard health education in preserving cognitive function among older adults. The interventions include diet, exercise, and mental activities designed to enhance brain health compared with regular health advice.

Participant Groups

Group I: Lifestyle Intervention Experimental Treatment 1 Intervention

This arm involves an active intervention with health coaching and lifestyle changes.

Group II: Standard Health Education Active Control 1 Intervention

This arm receives a standard educational approach without the intensive intervention.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Healthy Minds Initiative

Lead Sponsor

Trials

1

Recruited

2,000+

American College of Lifestyle Medicine

Collaborator

Trials

1

Recruited

2,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Charles Drew University of Medicine and Science

Collaborator

Trials

54

Recruited

8,500+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

References

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

Body, Brain, Life for Cognitive Decline (BBL-CD): protocol for a multidomain dementia risk reduction randomized controlled trial for subjective cognitive decline and mild cognitive impairment. [2022]

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

Multidomain trials to prevent dementia: addressing methodological challenges. [2022]

3. 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]

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

Prevention of dementia: focus on lifestyle. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Correlates of quality of life for individuals with dementia living at home: the role of home environment, caregiver, and patient-related characteristics. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prevention Matters: Time for Global Action and Effective Implementation. [2019]

7. Ireland pubmed.ncbi.nlm.nih.gov

Life style interventions to reduce the risk of dementia. [2009]

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

Multidomain interventions for risk reduction and prevention of cognitive decline and dementia: current developments. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Beneficial and Impeding Factors for the Implementation of Health-Promoting Lifestyle Interventions-A Gender-Specific Focus Group Study. [2023]