A Home-based Personalized Multidomain RCT from the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In Canada, 1,700,000 adults are at risk of dementia, half of them with MCI,representing one of the largest groups at risk for an incurable disease. Epidemiological evidence suggests up to 40% of dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors. Given that current treatments cannot modify the disease, prevention is critical. SYNERGIC-2 offers a personalized multidomain intervention that combines physical and cognitive training, sleep, diet, and vascular-metabolic interventions in individuals with MCI to synergistically enhance their overall brain health including cognition and contributes to maintaining their independence. Importantly, interventions will be provided at home using an existing virtual platform reducing delivery complexity and expanding the accessibility to a wider population, thus decreasing potential inequities. Improving older adults' brain health and achieving even a modest two-year dementia incidence delay will have a projected saving of $218 Billion in Canada's healthcare system over 30 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: t
View:

• Ages 60-85 years.

• Having mild cognitive impairment (MCI) defined as meeting all of the following:

‣ Presence of subjective memory complaints from the participant and/or informant.

⁃ Objective impairment on cognitive tests independent of outcome measures.†

⁃ Preserved activities of daily living assessed (\>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities.

⁃ Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5

• Have ≥1 additional dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score \>7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking).

• Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences).

• Self-reported levels of proficiency in English for speaking and understanding spoken and written language.

• Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen.

• Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance.

• Able to comply with virtual visits, treatment plan, and trial-related activities.

• Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ).

Locations
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
University of New Brunswick
RECRUITING
Fredericton
St. Joseph's Health Care London, Parkwood Hospital
RECRUITING
London
Concordia University
RECRUITING
Montreal
University of Ottawa
RECRUITING
Ottawa
Baycrest Academy for Research and Education
RECRUITING
Toronto
University of British Columbia
RECRUITING
Vancouver
University of Waterloo
RECRUITING
Waterloo
Contact Information
Primary
Diana Amaris
Diana.Amaris@sjhc.london.on.ca
519-646-6100
Backup
Frederico Faria, PhD
Frederico.Faria@sjhc.london.on.ca
519-646-6100
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 275
Treatments
Active_comparator: SYNERGIC 2
Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including:~1. Physical Exercise~2. Cognitive Training~3. Diet~4. Sleep~5. Vascular Risk Factors Control
Placebo_comparator: Brain Health PRO (BHPro)
Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to:~1. Physical Exercise~2. Cognitive Training~3. Diet~4. Sleep~5. Vascular Risk Factors~6. Social engagement
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov