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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how lifestyle changes can help prevent dementia by focusing on five key areas: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental well-being. Participants will receive a Personalized Dementia Risk Reduction Program to lower their dementia risk and will undergo regular assessments to track changes. The trial is open to individuals aged 50 or older who speak English well and do not have a dementia diagnosis. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on dementia prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that personalized plans to lower dementia risk are generally safe for participants. In a two-year clinical trial, these plans improved thinking skills and reduced dementia risk, indicating they are well-tolerated.

The focus includes lifestyle changes such as increasing physical activity, consuming brain-healthy foods, engaging in mental exercises, building social connections, and enhancing mental well-being. These activities typically do not raise safety concerns or cause negative effects. Studies suggest that addressing lifestyle risk factors can slow memory and thinking problems without posing risks to participants.

In summary, the activities in this program resemble general health advice and are considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Dementia Risk Reduction Program because it offers a holistic approach to preventing dementia that goes beyond the traditional methods focused on medication. Unlike current treatments that often address symptoms after they appear, this program emphasizes proactive lifestyle changes, including physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing. By encouraging a comprehensive lifestyle overhaul, this program aims to reduce dementia risk factors before they manifest, providing a potentially more effective and sustainable way to maintain brain health. This proactive and integrative strategy could revolutionize how we approach dementia prevention, making it a promising avenue for future healthcare.

What evidence suggests that this trial's treatments could be effective for dementia prevention?

Research has shown that personalized programs focusing on different life areas can lower the risk of dementia. This trial will evaluate various lifestyle interventions, including physical activity, brain-healthy eating, cognitive engagement, social connections, and mental well-being, as separate treatment arms. One study found that a personalized plan over two years led to some improvement in thinking skills and reduced the risk of dementia. A review of various studies supports the idea that addressing several lifestyle factors can be effective, especially in middle age. The Lancet Commission suggests that lifestyle changes, such as better diet and more exercise, provide promising evidence for preventing dementia. Overall, attention to changeable risk factors like physical activity, diet, and social connections can positively impact brain health. ^{1 2 5 6 7}

Who Is on the Research Team?

Nicole D. Anderson, PhD, CPsych

Principal Investigator

Baycrest

Howard Chertkow, MD

Principal Investigator

Baycrest

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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.

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10682943/

Effect of Personalized Risk-Reduction Strategies on ...

In this randomized clinical trial, a 2-year, personalized, multidomain intervention led to modest improvements in cognition, dementia risk ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2274580725001323

A systematic review of targeted dementia risk reduction ...

This review assessed the current literature on multidomain dementia risk-reduction interventions in mid-life.

3.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(24)01296-0/abstract

Dementia prevention, intervention, and care: 2024 report of ...

The 2024 update of the Lancet Commission on dementia provides new hopeful evidence about dementia prevention, intervention, and care. As people live longer, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10836551/

Programme Dementia Prevention (pdp) - PubMed Central - NIH

To determine and visualize an individual's potential for improvement in terms of dementia risk reduction, we employ the LIfestyle for BRAin ...

5.

alz.org

alz.org/professionals/public-health/public-health-topics/risk-reduction

Dementia Risk Reduction & Public Health

A growing body of evidence shows that addressing certain modifiable risk factors and promoting healthy behaviors can reduce the risk of cognitive decline.

6.

link.springer.com

link.springer.com/article/10.14283/jpad.2024.98

The Kimel Family Centre for Brain Health and Wellness

A research-driven community centre testing the efficacy of personalized dementia risk reduction programming on dementia risk and cognition.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04616794

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.