Clinical trial NCT06933667: Kimel Family Centre for Brain Health and Wellness
Official title: Kimel Family Centre for Brain Health and Wellness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention
Dementia
Keywords: personalized dementia prevention
lifestyle factors
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 450
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Diagnosis of dementia.

Primary outcomes:
measure: Physical Activity
timeFrame: Every six months over two years.
measure: Cognition
timeFrame: We expect to see this at the two year mark.
measure: Brain-Healthy Eating
timeFrame: Every six months over two years.
measure: Cognitive Engagement
timeFrame: Every six months over two years.
measure: Social Connections
timeFrame: Every six months over two years.
measure: Mental Wellbeing
timeFrame: Every six months over two years.
measure: Diastolic Blood Pressure
timeFrame: Every year over two years.
measure: Systolic Blood Pressure
timeFrame: Every year over two years.
measure: Percent body fat
timeFrame: Every year over two years.
measure: Low density lipoprotein
timeFrame: Every year over two years.
measure: C-reactive protein
timeFrame: Every year over two years.
measure: Interleukin-6
timeFrame: Every year over two years.
measure: HbA1c
timeFrame: Every year over two years.
measure: Cognition
timeFrame: Every six months over two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest
state: Ontario
Study officials:
affiliation: Baycrest
name: Nicole D. Anderson, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Baycrest
name: Howard Chertkow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.