Lifestyle Interventions for Dementia Prevention

Overseen By Nicole D. Anderson, PhD, CPsych

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baycrest

Disqualifiers: Dementia

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

Compensation: Varies

Number of Visits: 3

450 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.

What data supports the effectiveness of the Personalized Dementia Risk Reduction Program treatment?

Research suggests that lifestyle changes targeting multiple risk factors can help reduce the risk of dementia. Programs like My Healthy Brain, which focus on improving lifestyle habits such as diet, exercise, and sleep, have shown potential in improving cognitive and psychosocial outcomes in older adults. ^{1 2 3 4 5}

Is the Personalized Dementia Risk Reduction Program safe for humans?

The research suggests that lifestyle interventions for dementia prevention, which include changes in physical activity, cognitive stimulation, nutrition, and sleep, are generally safe for humans. These interventions focus on modifying risk factors without using drugs, which typically have fewer safety concerns. ^{2 3 4 6 7}

How is the Personalized Dementia Risk Reduction Program treatment different from other treatments for dementia prevention?

The Personalized Dementia Risk Reduction Program is unique because it focuses on a personalized approach to reduce dementia risk by addressing multiple lifestyle factors such as physical activity, cognitive stimulation, nutrition, and sleep, rather than relying on medication. This multidomain strategy aims to modify several risk factors simultaneously, which has shown promise in maintaining and improving cognitive capacity among older individuals at risk. ^{3 4 7 8 9}

What is the purpose of this trial?

Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) receive a comprehensive dementia risk assessment, including nonmodifiable and modifiable risk factors, from which they receive a Personalized Dementia Risk Report and Program Strategy, indicating their health conditions increasing and their risk level in five modifiable risk domains: physical activity, brain- healthy eating, cognitive engagement, social connections, and mental wellbeing. Equipped with this information, participants enroll in programs within the Centre to address their risk factors. Changes to their dementia risk, cognition, and Personalized Program Strategy are communicated through re-assessments of risk factors every six months (risk and cognition) and every year (comprehensive assessment).

Research Team

Howard Chertkow, MD

Principal Investigator

Baycrest

Nicole D. Anderson, PhD, CPsych

Principal Investigator

Baycrest

Eligibility Criteria

This trial is for individuals aged 50 and older who do not have dementia but may be at risk. They must speak English well enough to participate in assessments and programs aimed at reducing dementia risk through lifestyle changes.

Inclusion Criteria

Sufficiently fluent in English to complete the assessments and participate in programming.

I am 50 years old or older.

Exclusion Criteria

I have been diagnosed with dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment including biosample collection, questionnaires, and clinical evaluations to receive a Personalized Dementia Risk Report and Program Strategy.

4 weeks

1 visit (in-person), 1 session (virtual or in-person)

Program Enrollment and Initial Treatment

Participants enroll in programs to address dementia risk factors, including physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing.

6 months

Ongoing participation in various programs

Re-assessment and Continued Treatment

Participants undergo re-assessments of risk factors and cognition every six months, with a comprehensive assessment every year to adjust their Personalized Program Strategy.

1 year

2 visits (in-person) for re-assessment

Follow-up

Participants are monitored for changes in dementia risk, cognition, and health factors over two years.

2 years

Treatment Details

Interventions

• Personalized Dementia Risk Reduction Program

Trial Overview The study tests a personalized approach to reduce dementia risk by focusing on five areas: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing. Participants receive regular assessments over time to track changes.

Participant Groups

Group I: Physical Activity Active Control 1 Intervention

Participants are encouraged to work up to the Canadian Guidelines of 150 minutes a week of moderate to vigorous activity and to focus on balance and stretching.

Group II: Brain-healthy Eating Active Control 1 Intervention

Participants are recommended to take five required courses about the CCNA Brain Health Food Guide, then take additional courses of their choice.

Group III: Cognitive Engagement Active Control 1 Intervention

Participants are encouraged to participate in at least one hour of cognitively engaging programs.

Group IV: Social Connections Active Control 1 Intervention

All programs, regardless of type, encourage social connections, through ice-breakers, peer mentoring, and time to chat before and after classes.

Group V: Mental Wellbeing Active Control 1 Intervention

Participants are encouraged to participate in at least one hour of programming focused on mental wellbeing (e.g., meditation, relaxation).

Who Is Running the Clinical Trial?

Baycrest

Lead Sponsor

Trials

46

Recruited

6,900+

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]

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]

References

1. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

A brief update on dementia prevention. [2021]

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

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

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

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

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

Modifiable Risk Factors for Brain Health and Dementia and Opportunities for Intervention: A Brief Review. [2023]

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

A 12-week multidomain intervention versus active control to reduce risk of Alzheimer's disease: study protocol for a randomized controlled trial. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Engaging Patients to Design the Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) Intervention: Findings from a Web-Based Survey. [2021]

8. 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]

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

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