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Recruiting NCT06933667

Kimel Family Centre for Brain Health and Wellness

No phase Interventional Prevention Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Activity, Brain-healthy Eating, Cognitive Engagement, Social Connections.
Who it may be relevant to
Registry conditions: Prevention, Dementia. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Physical Activity
    Participants can chose (with input from a kinesiologist as required) from courses of varying intensity in our gym, warm water pool, or classrooms.
  • Behavioral Brain-healthy Eating
    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.
  • Behavioral Cognitive Engagement
    Participants can sign up for any lecture, discussion group, book club, creative arts program, etc. linked to the Cognitive Engagement risk factor.
  • Behavioral Social Connections
    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.
  • Behavioral Mental Wellbeing
    Participants are encouraged to enroll in one a week of relevant programming (e.g., meditation, relaxation).

Primary outcome measures

  • Physical Activity [Time frame: Every six months over two years.]
  • Cognition [Time frame: We expect to see this at the two year mark.]
  • Brain-Healthy Eating [Time frame: Every six months over two years.]
  • Cognitive Engagement [Time frame: Every six months over two years.]
  • Social Connections [Time frame: Every six months over two years.]
  • Mental Wellbeing [Time frame: Every six months over two years.]
  • Diastolic Blood Pressure [Time frame: Every year over two years.]
  • Systolic Blood Pressure [Time frame: Every year over two years.]
  • Percent body fat [Time frame: Every year over two years.]
  • Low density lipoprotein [Time frame: Every year over 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • Baycrest — Toronto

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. PMID 39350393

Identifiers

NCT: NCT06933667 · #23-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗