A Home-based Personalized Multidomain RCT from the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Lawson Health Research Institute
- Enrollment
- 275
- Locations
- 8
- Primary Endpoint
- Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
Time Frame: baseline and at 48 weeks (after interventions finalized)
Global cognition will be assessed using the cognitive section of the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13). This scale consists of 13 brief cognitive tests assessing attention, memory, language, executive function, praxis, orientation, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD to measure changes in cognitive performance in populations with cognitive impairment, it score ranges from 0 to 84, with higher scores indicating worse cognitive performance.
Secondary Outcomes
- Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Eating Pattern Self-Assessment(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in Insomnia Severity Index(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in International Physical Activity Questionnaire scores(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Health Resource Utilization Questionnaire (HRUQ)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Mediterranean Diet Assessment(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Quality of Life Questionnaire (SF-36)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Cognitive Expectancies Questionnaire(Baseline and follow-up at 12 months)
- Changes in sleep pattern(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Identification of APO-E variants, a planned panel of 31 single nucleotide polymorphisms (SNPs), and untargeted metabolomics(Baseline and follow-up at 12 months)
- Change in Anthropometric Measures(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in the CCNA Gait Assessments results-Walking performance(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Clinical Dementia Rating scores(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Fall Occurrence(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in Generalized Anxiety Disorder (GAD-7)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Geriatric Depression Scale (GDS-30)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Health Utility Index (HUI-3)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in global cognitive function using Montreal Cognitive Assessment(MoCA)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in the Oral Trail Making Test - Attention Shifting capabilities/executive functions using(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in EEG(Baseline and follow-up at 12 months)
- Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in behavior(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in physical activity in the elderly(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in BHPro questionnaires(Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months)
- Changes in Resource Use Inventory Q7 & Q8 (RUI Q7 &Q8)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in 60s Chair Standing Test(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in The Activities-specific Balance Confidence Scale (ABC) questionnaire(Baseline, mid-intervention at 6 months, and follow-up at 12 months)
- Changes in The Short Physical Performance Battery (SPPB)(Baseline, mid-intervention at 6 months, and follow-up at 12 months)