PreventionNCT06933667
Kimel Family Centre for Brain Health and Wellness
A study testing Physical Activity, Brain-healthy Eating and Cognitive Engagement in people with Prevention and Dementia, run by Baycrest at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention, Dementia
- What is being tested?
- Physical Activity, Brain-healthy Eating and Cognitive Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50 years or older
- Sufficiently fluent in English to complete the assessments and participate in programming.
Who cannot join
- Diagnosis of dementia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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) 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).
Read the detailed description
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.
- Conditions
- Prevention, Dementia
- Being tested
- Physical Activity, Brain-healthy Eating, Cognitive Engagement, Social Connections, Mental Wellbeing
- Keywords
- personalized dementia prevention, lifestyle factors
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
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 EatingBehavioural
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 EngagementBehavioural
Participants can sign up for any lecture, discussion group, book club, creative arts program, etc. linked to the Cognitive Engagement risk factor.
Social ConnectionsBehavioural
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 WellbeingBehavioural
Participants are encouraged to enroll in one a week of relevant programming (e.g., meditation, relaxation).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Active comparator | 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. Receives: Behavioral: Physical Activity |
| Brain-healthy Eating | Active comparator | Participants are recommended to take five required courses about the CCNA Brain Health Food Guide, then take additional courses of their choice. Receives: Behavioral: Brain-healthy Eating |
| Cognitive Engagement | Active comparator | Participants are encouraged to participate in at least one hour of cognitively engaging programs. Receives: Behavioral: Cognitive Engagement |
| Social Connections | Active comparator | All programs, regardless of type, encourage social connections, through ice-breakers, peer mentoring, and time to chat before and after classes. Receives: Behavioral: Social Connections |
| Mental Wellbeing | Active comparator | Participants are encouraged to participate in at least one hour of programming focused on mental wellbeing (e.g., meditation, relaxation). Receives: Behavioral: Mental Wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Hours of moderate-to-vigorous physical activity a week, as determined by the CHAMPS (0 - 168, with higher scores indicating greater activity).
Measured: Every six months over two years.
Cognition
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.
Measured: We expect to see this at the two year mark.
Brain-Healthy Eating
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).
Measured: Every six months over two years.
Cognitive Engagement
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).
Measured: Every six months over two years.
Social Connections
Degree of loneliness as assessed by the UCLA Loneliness Scale (Version 3; range = 0-80, where higher scores indicate greater loneliness).
Measured: Every six months over two years.
Mental Wellbeing
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).
Measured: Every six months over two years.
Diastolic Blood Pressure
Diastolic Blood Pressure, which lower numbers indicated better blood pressure.
Measured: Every year over two years.
Systolic Blood Pressure
Systolic Blood Pressure, where lower numbers indicate better blood pressure
Measured: Every year over two years.
Percent body fat
Percent body fat as determined by dual-energy X-ray absorptiometry (DXA), where lower numbers indicate less body fat.
Measured: Every year over two years.
Low density lipoprotein
Low density lipoprotein, assessed via blood draw, where lower numbers indicate less cholesterol.
Measured: Every year over two years.
C-reactive protein
C-reactive protein, assessed via blood draw, where lower numbers indicate less inflammation.
Measured: Every year over two years.
Interleukin-6
Interleukin-6, assessed via blood draw, where lower numbers indicate less inflammation.
Measured: Every year over two years.
HbA1c
Hemoglobin A1C (HbA1c), measured through blood draw, where lower numbers indicate less blood sugar.
Measured: Every year over two years.
Cognition
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).
Measured: Every six months over two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start26 Mar 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants are encouraged to sign up for programs that address their specific cluster of modifiable dementia risk factors in five domains: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole D. Anderson, PhD, CPsych, Principal investigator, BaycrestHoward Chertkow, MD, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933667
- Sponsor's protocol ID
- #23-26
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants are asked during consent if they consent to Open Science (as per Canadian TriCouncil Guidelines). For those who do, we will deposit the data on the Open Science Framework within three years of study completion. Data requests can also be made prior to this point by completing a Data Request Form (available from the PIs).
Publications
Anderson ND, D'Amico D, Rotenberg S, Addis DR, Gillen J, Moore D, Furlano JA, Tan B, Binns M, Santarossa M, Chertkow H. Validation of a Community-Based Approach Toward Personalized Dementia Risk Reduction: The Kimel Family Centre for Brain Health and Wellness. J Prev Alzheimers Dis. 2024;11(5):1455-1466. doi: 10.14283/jpad.2024.98.
PubMed 39350393
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kimel Family Centre for Brain Health and Wellness
- ClinicalTrials.gov ID
- NCT06933667
- Acronym / sponsor ID
- #23-26
- Conditions
- Prevention, Dementia
- Keywords
- personalized dementia prevention, lifestyle factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants are encouraged to sign up for programs that address their specific cluster of modifiable dementia risk factors in five domains: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Active comparator | Behavioral: Physical ActivityParticipants 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. |
| Brain-healthy Eating | Active comparator | Behavioral: Brain-healthy EatingParticipants are recommended to take five required courses about the CCNA Brain Health Food Guide, then take additional courses of their choice. |
| Cognitive Engagement | Active comparator | Behavioral: Cognitive EngagementParticipants are encouraged to participate in at least one hour of cognitively engaging programs. |
| Social Connections | Active comparator | Behavioral: Social ConnectionsAll programs, regardless of type, encourage social connections, through ice-breakers, peer mentoring, and time to chat before and after classes. |
| Mental Wellbeing | Active comparator | Behavioral: Mental WellbeingParticipants are encouraged to participate in at least one hour of programming focused on mental wellbeing (e.g., meditation, relaxation). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 50 years or older
- Sufficiently fluent in English to complete the assessments and participate in programming.
Key exclusion criteria (1 listed)
- Diagnosis of dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityParticipants can chose (with input from a kinesiologist as required) from courses of varying intensity in our gym, warm water pool, or classrooms. | Behavioural | Physical Activity |
| Brain-healthy EatingParticipants 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. | Behavioural | Brain-healthy Eating |
| Cognitive EngagementParticipants can sign up for any lecture, discussion group, book club, creative arts program, etc. linked to the Cognitive Engagement risk factor. | Behavioural | Cognitive Engagement |
| Social ConnectionsSocial 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. | Behavioural | Social Connections |
| Mental WellbeingParticipants are encouraged to enroll in one a week of relevant programming (e.g., meditation, relaxation). | Behavioural | Mental Wellbeing |
Primary outcome
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).
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.
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).
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).
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).
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).
Diastolic Blood Pressure
Time frame: Every year over two years.
Diastolic Blood Pressure, which lower numbers indicated better blood pressure.
Systolic Blood Pressure
Time frame: Every year over two years.
Systolic Blood Pressure, where lower numbers indicate better blood pressure
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.
Low density lipoprotein
Time frame: Every year over two years.
Low density lipoprotein, assessed via blood draw, where lower numbers indicate less cholesterol.
C-reactive protein
Time frame: Every year over two years.
C-reactive protein, assessed via blood draw, where lower numbers indicate less inflammation.
Interleukin-6
Time frame: Every year over two years.
Interleukin-6, assessed via blood draw, where lower numbers indicate less inflammation.
HbA1c
Time frame: Every year over two years.
Hemoglobin A1C (HbA1c), measured through blood draw, where lower numbers indicate less blood sugar.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 39350393Anderson ND, D'Amico D, Rotenberg S, Addis DR, Gillen J, Moore D, Furlano JA, Tan B, Binns M, Santarossa M, Chertkow H. Validation of a Community-Based Approach Toward Personalized Dementia Risk Reduction: The Kimel Family Centre for Brain Health and Wellness. J Prev Alzheimers Dis. 2024;11(5):1455-1466. doi: 10.14283/jpad.2024.98.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participants are asked during consent if they consent to Open Science (as per Canadian TriCouncil Guidelines). For those who do, we will deposit the data on the Open Science Framework within three years of study completion. Data requests can also be made prior to this point by completing a Data Request Form (available from the PIs).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole D. Anderson, PhD, CPsych principal investigator
Baycrest
Howard Chertkow, MD principal investigator
Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity, Brain-healthy Eating and Cognitive Engagement in people with Prevention and Dementia, run by Baycrest at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole D. Anderson, PhD, CPsych (416-785-2500 ext. 3366, nanderson@research.baycrest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Every six months over two years.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.