NCT05375513

SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@home)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

Epidemiological evidence suggests up to 40% of potential dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors; given that current treatments cannot modify the disease, prevention is a critical aspect. SYNERGIC-2 is the first large Canadian clinical trial using a 12-month home-based personalized multidomain lifestyle intervention to improve cognition in 550 older adults with Mild Cognitive Impairment (MCI), a pre-dementia state. These personalized at-home interventions target 5 domains with tailored physical exercise, cognitive training, diet recommendations, sleep interventions, and vascular risk factor management and are all delivered using a digital platform. Specifically, SYNERGIC-2 will be conducted with participants in their homes using video-conference meetings to test participants and to coach them 1-on-1 through the interventions on a web-based digital platform. The effect of these combined interventions on cognition will be compared to an online-educational program Brain Health PRO (BHPro). Both interventions are part of CAN-THUMBS UP, the interventional platform of the CCNA related to Canada Dementia Research Strategy; and constitutes Canada's contribution to the World-Wide-FINGERS Network. Importantly, these interventions have been selected because there is evidence that they synergistically enhance overall brain health including cognition and contributes to maintaining independence for individuals at risk for developing dementia.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-05
• Primary completion: 2025-11-30
• Completion: 2026-12-30
• First posted: 2022-05-16
• Last updated: 2024-10-29

Locations

8 sites across 1 country: Canada