Status:
COMPLETED
Brain Health Support Program
Lead Sponsor:
Baycrest
Conditions:
Dementia Prevention
Mild Cognitive Impairment
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP, or CTU) is a comprehensive and innovative program aimed to develop, implement and evaluate an ...
Eligibility Criteria
Inclusion
- Completion and documentation of the electronic Informed Consent Process (from the participant)
- Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
- Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)
- Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
- Ability to sit comfortably for a period of about 30 minutes
- Ages 60-85
- Meets criteria for No Dementia and meet criteria \[according to Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1\] of one of the following:
- Cognitively Unimpaired (CU)
- Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + SCI)
- Mild Cognitive Impairment (MCI)
- AND Classified as being at increased risk of dementia based on at least one of the following:
- First-degree family history of dementia
- Self-Reported or documented current and/or history at midlife (45-60 years) on any of the following lifestyle risk factors:
- Hypertension (documented Systolic Blood Pressure \> 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise)) Hypercholesterolemia (documented total cholesterol \> 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise) Body Mass Index \> 30 kg/m2 (derived from NIH Metric BMI Calculator) Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
- Participant has a family physician or other healthcare provider and agrees to have the provider notified of participation in the study and incidental or other findings that may be clinically significant
Exclusion
- Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.
- Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
- Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
- Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments
- Individuals who have a clinical diagnosis of Dementia
- Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of \>1
- Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) \<13
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT05347966
Start Date
April 6 2022
End Date
April 19 2024
Last Update
May 2 2025
Active Locations (7)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
2
University of New Brunswick
Fredericton, New Brunswick, Canada, E3B 5A3
3
Cape Breton University
Cape Breton, Nova Scotia, Canada, B1M 1A2
4
Cognitive Clinical Research Group, Parkwood Research Institute
London, Ontario, Canada, N6C 5J1