Kimel Family Centre for Brain Health and Wellness

Baycrest

Status: Enrolling

Conditions: Prevention; Dementia

Treatments: Behavioral: Social Connections; Behavioral: Cognitive Engagement; Behavioral: Mental Wellbeing; Behavioral: Brain-healthy Eating; Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06933667

#23-26

Details and patient eligibility

About

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).

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Diagnosis of dementia.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

450 participants in 5 patient groups

Physical Activity

Active Comparator group

Description:

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.

Treatment:

Behavioral: Physical Activity

Brain-healthy Eating

Active Comparator group

Description:

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

Treatment:

Behavioral: Brain-healthy Eating

Cognitive Engagement

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive Engagement

Social Connections

Active Comparator group

Description:

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

Treatment:

Behavioral: Social Connections

Mental Wellbeing

Active Comparator group

Description:

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

Treatment:

Behavioral: Mental Wellbeing