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Recruiting

NCT Number: NCT06933667

Kimel Family Centre for Brain Health and Wellness

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).

Recruiting

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Key information

Conditions

Prevention Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location status: Recruiting

About this study

Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) complete a baseline assessment consisting of three parts. A biosample session in which blood is drawn to measure HbA1c, cholesterols, thyroid levels, c-reactive protein, interleukin-6, homocysteine, and BDNF, and a saliva sample is provided to provide a polygenic risk score for AD. A questionnaire session is completed on a tablet or from home asks about demographics, health conditions, and five targeted modifiable factors: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing. A clinical session measures vitals, sensory function, frailty markers (grip strength, DXA, ultrasound of right quadriceps muscle), dual-task gait, and cognition (MoCA and Cogniciti's Brain Health Assessment). From that assessment, participants receive a Personalized Dementia Risk Report and Program Strategy, outlining conditions that are known to increase dementia risk, with resources provided on how to get them addressed, as well as their risk level in the five targeted domains. Participants then take a SMART goal setting workshop to identify SMART goals addressing their dementia risk factors, and then sign up for programming in the centre to reduce their risk. After six months, their risk in the five targeted domains, cognition (Brain Health Assessment), and satisfaction are re-assessed, and every year, most of the baseline assessment is repeated. We expect that this personalized approach will result in reductions in risk in the five targeted domains within the first six months, improvements in health factors within the first year, and improvements in cognition within two years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50 years or older
  • Sufficiently fluent in English to complete the assessments and participate in programming.

Exclusion criteria

  • Diagnosis of dementia.

Treatment and study plan

Physical activity

Behavioral

Participants can chose (with input from a kinesiologist as required) from courses of varying intensity in our gym, warm water pool, or classrooms.

Brain-healthy Eating

Behavioral

Participants take five foundational courses: Brain-healthy eating, Healthy protein choices, Colour your diet: Maximize the benefits of fruits and vegetables; Interpreting nutrition facts labels; and Salt and sugar: How much is too much? They are also encouraged to take additional nutrition programs.

Cognitive Engagement

Behavioral

Participants can sign up for any lecture, discussion group, book club, creative arts program, etc. linked to the Cognitive Engagement risk factor.

Social Connections

Behavioral

Social Connections are baked into all other programming. Our instructors are trained in how to foster connections among participants, through peer coaching, ice-breakers, etc., and are asked to leave some time at the beginning and end of programs for participants to chat. We also hold special social events such as game nights.

Mental Wellbeing

Behavioral

Participants are encouraged to enroll in one a week of relevant programming (e.g., meditation, relaxation).

Primary outcomes

  1. Physical Activity

    Time frame: Every six months over two years.

    Hours of moderate-to-vigorous physical activity a week, as determined by the CHAMPS (0 - 168, with higher scores indicating greater activity).

  2. Cognition

    Time frame: We expect to see this at the two year mark.

    We expect cognition to be maintained or improved, as assessed by Cogniciti's Brain Health Assessment, to the extent that participants adhere to their Personalized Program Strategy.

  3. Brain-Healthy Eating

    Time frame: Every six months over two years.

    Brain-healthy eating as assessed by the Brain Health Food Guide derived Eating Pattern Self-Assessment (range 0 - 15, with higher scores indicating greater adherence to the Brain Health Food Guide).

  4. Cognitive Engagement

    Time frame: Every six months over two years.

    Amount of engagement in higher-order cognitively engaging activities, as assessed by the Higher Cognition subscale of the Florida Cognitive Activities Scale (range 0-40, with higher scores indicated greater engagement).

  5. Social Connections

    Time frame: Every six months over two years.

    Degree of loneliness as assessed by the UCLA Loneliness Scale (Version 3; range = 0-80, where higher scores indicate greater loneliness).

  6. Mental Wellbeing

    Time frame: Every six months over two years.

    A composite of depression, anxiety, and (dis)stress from the Depression, Anxiety, and Stress Scale-21 (DASS-21), as well as perceived stress from the Perceived Stress Scale (with each subscale converted to a percentage of maximum and summed; range: 0 - 400).

  7. Diastolic Blood Pressure

    Time frame: Every year over two years.

    Diastolic Blood Pressure, which lower numbers indicated better blood pressure.

  8. Systolic Blood Pressure

    Time frame: Every year over two years.

    Systolic Blood Pressure, where lower numbers indicate better blood pressure

  9. Percent body fat

    Time frame: Every year over two years.

    Percent body fat as determined by dual-energy X-ray absorptiometry (DXA), where lower numbers indicate less body fat.

  10. Low density lipoprotein

    Time frame: Every year over two years.

    Low density lipoprotein, assessed via blood draw, where lower numbers indicate less cholesterol.

  11. C-reactive protein

    Time frame: Every year over two years.

    C-reactive protein, assessed via blood draw, where lower numbers indicate less inflammation.

  12. Interleukin-6

    Time frame: Every year over two years.

    Interleukin-6, assessed via blood draw, where lower numbers indicate less inflammation.

  13. HbA1c

    Time frame: Every year over two years.

    Hemoglobin A1C (HbA1c), measured through blood draw, where lower numbers indicate less blood sugar.

  14. Cognition

    Time frame: Every six months over two years.

    Cognition, assessed as an age- and sex-adjusted percentile on the Brain Health Assessment (an online cognitive assessment of episodic memory, working memory, and executive functioning).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole D. Anderson, PhD, CPsych

CONTACT

[email protected]

416-785-2500 ext. 3366

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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