SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@home)
NCT05375513 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275
Last updated 2024-10-29
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.
Conditions
Interventions
- OTHER
-
PMI@Home
Personalized multidomain interventional program by combining tailored lifestyle interventions that targets 5 domains: physical activity, cognition, diet, sleep, and vascular risk factors. These interventions are tailored based on participants' baseline profile and progress in intensity following the principles of personalized medicine. All aspects of the PMI@home will be delivered remotely, at participants' homes, using a "digital platform" with scheduled bi-weekly 1-to1 coaching sessions. Delivery of interventions and assessments are centralized with 5 trained staff at the sponsor site (London) to assure logistics, standardization, and quality control.
- OTHER
-
Brain Health Pro
Online Modules: * Motivation, Self-Efficacy, Positive Health, Environment and Genetic risk * Physical Activity * Cognitively Stimulating Activities * Diet * Sleep * Social and Psychological Health * Vascular health * Vision and Hearing * Lifestyle Risk Impact Surveys * Goal Setting
Sponsors & Collaborators
-
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
lead OTHER
Principal Investigators
-
Manuel Montero-Odasso, MD, PhD · St. Joseph's Health Care London, Parkwood Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-05
- Primary Completion
- 2025-11-30
- Completion
- 2026-12-30
Countries
- Canada
Study Locations
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