2000 Participants Needed

Lifestyle Intervention for Dementia Prevention

(INSPIRE Trial)

CS
DS
Overseen ByDean Sherzai, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Healthy Minds Initiative
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes can help prevent dementia and improve brain health, focusing specifically on African American communities, which often face a higher impact from lifestyle-related diseases. Participants will either receive health coaching and make lifestyle changes (referred to as Lifestyle Intervention) or receive standard health education. African Americans aged 55 or older, living near Crenshaw, California, with mild or normal cognitive function, may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance community health and personal well-being.

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 prior data suggests that this lifestyle intervention is safe for cognitive health?

Past research has shown that lifestyle changes, such as increased exercise and a healthy diet, can lower the risk of dementia. These studies suggest that people usually find these changes manageable. Participants often reported few, if any, side effects. The focus remains on improving habits like staying active and eating well, which are safe and beneficial for most individuals. Since these changes integrate into daily life, they are considered safe for health. This makes them a good option for those aiming to boost brain health and potentially reduce the risk of dementia.12345

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Intervention for dementia prevention because it focuses on empowering individuals with personalized health coaching and lifestyle changes, which is a shift from the usual reliance on medication. Unlike standard treatments that may involve drugs targeting symptoms, this intervention aims to tackle the root causes by promoting healthy habits like diet, exercise, and cognitive activities. This approach has the potential to not only prevent dementia but also improve overall well-being, making it a holistic alternative to current options.

What evidence suggests that this lifestyle intervention is effective for dementia prevention?

Research has shown that lifestyle changes can greatly benefit brain health. In this trial, participants in the Lifestyle Intervention arm will engage in active intervention with health coaching and lifestyle changes. Studies have found that regular exercise can reduce the risk of dementia in as little as 6–8 weeks. Another study discovered that a combination of healthy eating, exercise, socializing, and mental activities can enhance thinking skills and daily life for people with early memory issues. In many cases, significant lifestyle changes improved mental abilities and daily functioning after just 20 weeks. These changes seem to work by addressing multiple areas at once, leading to better overall brain health.26789

Who Is on the Research Team?

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Dean Sherzai, MD, PhD

Principal Investigator

Healthy Minds Initiative

Are You a Good Fit for This Trial?

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.
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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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
Group II: Standard Health EducationActive Control1 Intervention

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

🇺🇸
Approved in United States as Lifestyle Intervention for:
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Approved in European Union as Lifestyle Intervention for:

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Dietary changes following a lifestyle-based intervention for ...This study assessed effects of a 2-year multidomain lifestyle intervention on a healthy diet in older adults at increased risk for dementia.
Lifestyle interventions for dementia risk reduction: A review ...As a lifestyle intervention, exercise and physical activity, regardless of type, have been shown to reduce the risk of dementia within just 6–8 weeks [18,19].
Single-domain and multidomain lifestyle interventions for ...This network meta-analysis aimed to compare and rank the relative efficacy of single-domain and multidomain lifestyle interventions for the ...
Effects of intensive lifestyle changes on the progression of ...Comprehensive lifestyle changes may significantly improve cognition and function after 20 weeks in many patients with MCI or early dementia due to AD.
Evaluation of the Effect of Healthy Lifestyle Intervention for ...This study combines exercise, social activities, diet, and cognitive training to systematically evaluate the comprehensive effects of multidimensional healthy ...
a randomized, controlled clinical trial - PMC - PubMed CentralAll these studies showed that lifestyle changes may help prevent dementia. The study we are reporting here is the first randomized, controlled ...
U.S. POINTER StudyU.S. POINTER is a lifestyle intervention clinical trial to support brain health, improve cognition & speed progress in Alzheimer's and dementia research.
Study design and methods: U.S. study to protect brain health ...The U.S. study to protect brain health through lifestyle intervention to reduce risk (U.S. POINTER) is conducted to confirm and expand the ...
Intervention on Modifiable Lifestyle Risk Factors for ...The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help older adults reduce their risk for dementia.
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