SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@home)
- Conditions
- Mild Cognitive Impairment
- Interventions
- Other: PMI@HomeOther: Brain Health Pro
- Registration Number
- NCT05375513
- Lead Sponsor
- Lawson Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 275
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SYNERGIC 2 PMI@Home 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 Brain Health PRO (BHPro) Brain Health Pro 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
- Primary Outcome Measures
Name Time Method Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13) 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 Outcome Measures
Name Time Method Changes in Health Resource Utilization Questionnaire (HRUQ) Baseline, mid-intervention at 6 months, and follow-up at 12 months The HRUQ provides an overall assessment of a participants utilization of health-related resource use and costs for elderly adults with and without mild cognitive impairment.There is no scoring for the HRUQ
Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale Baseline, mid-intervention at 6 months, and follow-up at 12 months Measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing the ability to independently perform activities such as using the telephone, shopping, preparing meals, chores, household activities, managing prescriptions and medications, and managing personal finances. Score ranges from 0-23.
Changes in the Mediterranean Diet Assessment Baseline, mid-intervention at 6 months, and follow-up at 12 months A 14-item questionnaire to help evaluate a participants Mediterranean ingredients in their diet. Score ranges from 0-14.
Changes in Quality of Life Questionnaire (SF-36) Baseline, mid-intervention at 6 months, and follow-up at 12 months The Short-Form Quality of Life Questionnaire (SF-36) is a 36-item questionnaire assessing quality of life, with scores ranging from 0 to 100 and higher scores indicating better quality of life.
Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed) Baseline, mid-intervention at 6 months, and follow-up at 12 months The Digit Symbol Modalities Test is a 90-second, timed task that asks participants to orally match geometric figures with specific numbers according to a defined key (specifying which symbols are assigned to which numbers) that is provided at the top of the stimulus page. The oral Digit Symbol Modalities Test measures processing speed capabilities. The total number of numbers correctly matched with symbols is the final score for this test ranging from 0-110 correct numbers sequentially spoken.
Changes in Eating Pattern Self-Assessment Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months The Eating Pattern Self-Assessment (EPSA) is a 12-item questionnaire assessing participants' dietary intake profiles over the past 12 months. No score provided
Changes in Insomnia Severity Index Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months The Insomnia Severity Index (ISI) is a 7-item questionnaire assessing sleep onset, sleep maintenance, sleep satisfaction, and sleep problems.
Changes in International Physical Activity Questionnaire scores Baseline, mid-intervention at 6 months, and follow-up at 12 months Modified for the elderly people, assesses older adults' level of physical activity, with a simple 7-item questionnaire. Scoring ranges from low, moderate and high.
Changes in the Cognitive Expectancies Questionnaire Baseline and follow-up at 12 months It is a version developed by the CCNA to measures participant's expectancies about the cognitive benefits of the intervention. Score ranges from 1 to 88. This questionnaire measures the participant's perception about the interventions. The questionnaire outcome is not related to participant's cognition, but participant's subjective perception about the interventions.
Changes in sleep pattern Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months The Sleep Diary is self-administered of 10-days of sleep patterns to assess sleep quality and total of sleep time. It also helps to identify possible sleep disruptions that may affect sleep quality and identify certain habits that may explain sleeping issues.
Identification of APO-E variants, a planned panel of 31 single nucleotide polymorphisms (SNPs), and untargeted metabolomics Baseline and follow-up at 12 months Participants will use the DNA-Genotek, which is a self-administered saliva collection kit to analyze saliva sample for possible identification of APO-E variants, a planned panel of 31 single nucleotide polymorphisms (SNPs), and untargeted metabolomics.
Change in Anthropometric Measures Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months Measurements of weight and hip/waist circumference will be done at home and self-reported by the participant. This can be used to characterize participant's body dimension and determine body mass index as kg/m\^2 which can be used to estimate whether participants have obesity. A BMI greater than 30 is the cut off for obesity. Changes in waist circumference may also indicate visceral fat and cardiovascular risk.
Changes in the CCNA Gait Assessments results-Walking performance Baseline, mid-intervention at 6 months, and follow-up at 12 months The CCNA gait assessment includes preferred and fast pace gait, and dual-task gait that comprises walking while performing three cognitively demanding tasks: counting backwards by ones, counting backwards by sevens, and naming animals. Participants will be asked to walk on a designated walking path(4 meters) in sight of camera
Changes in Clinical Dementia Rating scores Baseline, mid-intervention at 6 months, and follow-up at 12 months The Clinical Dementia Rating (CDR) scale is a validated scale (0-3) used in longitudinal Alzheimer's Disease (AD) research to characterize the impact of cognitive decline on global function performance applicable to AD and related dementias. Information is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g. family member). A score of ) indicate no cognitive impairment; 0.5 for Mild cognitive impairment; 1 for early dementia; 2 for mild severe dementia; 3 for severe dementia
Changes in Fall Occurrence Baseline, mid-intervention at 6 months, and follow-up at 12 months The monthly falls calendar that will be sent to help track any participant falls. Participants are being asked to complete this calendar on a daily basis in order to help investigators better track whether or not they have fallen since last intervention. A fall is defined as any unintentional event in which a participant falls to the ground or onto an object (e.g., a chair) no caused by a syncope or loss of consciousness. Total number of falls and consequences of falls is provided.
Changes in Generalized Anxiety Disorder (GAD-7) Baseline, mid-intervention at 6 months, and follow-up at 12 months A questionnaire to score the frequency the participant experiences anxiety symptoms in the past 7 days with higher scores indicating worse anxiety symptoms. Score ranges from 0-21.
Change in Geriatric Depression Scale (GDS-30) Baseline, mid-intervention at 6 months, and follow-up at 12 months A questionnaire to establish a participant's experience with depressive symptoms with higher score indicating more severe depressive symptoms. Score ranges from 0-30.
Change in Health Utility Index (HUI-3) Baseline, mid-intervention at 6 months, and follow-up at 12 months The HUI-3 provides descriptive health profile measures on a generic scale with higher scores indicating better quality of life and global functionality. HUI also provides single-attribute scores of morbidities for the following attributes; vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Score ranges from one 1 to 6 or 1 to 5 depending on the domain; and sum of all domains could range from 8 to 45.
Changes in global cognitive function using Montreal Cognitive Assessment(MoCA) Baseline, mid-intervention at 6 months, and follow-up at 12 months The MoCA is a brief screening instrument designed to detect global cognitive dysfunction. It assesses a range of different cognitive domains, including attention, executive functions, memory, language, visuo-constructional skills, abstract thinking, and orientation. Score ranges from 0-30.
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 The Oral Trail Making Test (TMT) A \& B is a two-part test that assesses attention speed, and mental flexibility and has been widely used in clinical settings for assessing deficits in attention and executive functioning. Score from part A ranges from 0-180; part B from 0-300 seconds. Longer times mean worse performance in the test.
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia Baseline, mid-intervention at 6 months, and follow-up at 12 months The Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) is a short questionnaire assessing midlife vascular risk for dementia, with scores ranging from 0 to 15 (higher scores suggesting higher risk) and has cut-off score of 5 for high risk.
Changes in EEG Baseline and follow-up at 12 months Participants will use the MUSE-S EEG Headband for 3 consecutive nights. The MUSE S Headband is a commercially available consumer headband that has 7 sensors, 2 on the forehead, 2 behind the ears, plus 3 reference sensors, to detect and measure EEG signals when sleeping.
Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory Baseline, mid-intervention at 6 months, and follow-up at 12 months The Rey Auditory Verbal Learning Test (RAVLT) assesses episodic memory, in which the participant is presented with 15 words in five presentations or trials, after which they are asked to recall the words (immediately and after a delay). Score ranges from 0 to 15 words recalled.
Changes in behavior Baseline, mid-intervention at 6 months, and follow-up at 12 months This questionnaire asks about eleven health behaviors, to be rated on a 0 (low) to 10 (high) scale. Prior research has demonstrated that a 1-point change on these 0 to 10 items is clinically meaningful.
Changes in physical activity in the elderly Baseline, mid-intervention at 6 months, and follow-up at 12 months The Wrist (AX3) Accelerometer is used to detect movement, vibrations, and orientation changes to assess physical activity trends in older population.
Changes in BHPro questionnaires Baseline, month 3, mid-intervention at 6 months, month 9, and follow-up at 12 months These questionnaires ask about cognition (6-item questionnaire), vascular health (4-item questionnaire), and social and psychological health (8-item questionnaire).
* BHPro Questionnaire - Cognition: This questionnaire asks about participant's engagement in activities such as reading, crafting, and instrument playing. It does not provide any quantitative range score.
* BHPro Questionnaire - Social and Psychological Health: This questionnaire asks about participant's emotions and mood. It does not provide any quantitative range score.
* BHPro Questionnaire - Vascular Health: This questionnaire asks about participant's updated medical history. It does not provide any quantitative range score.Changes in Resource Use Inventory Q7 & Q8 (RUI Q7 &Q8) Baseline, mid-intervention at 6 months, and follow-up at 12 months Questions 7 and 8 from the Resource Use Inventory (RUI)28 questionnaire assess health-related resource use for caregivers. This instrument has been used for tracking resource use and costs in cognitively intact older adults, as well as with Alzheimer disease (AD). This is a self-report questionnaire investigates if participants received any help while preforming daily living tasks e.g., bathing, brushing, and getting the phone. It does not provide any quantitative range score.
Changes in 60s Chair Standing Test Baseline, mid-intervention at 6 months, and follow-up at 12 months Participants will be performing the one-minute chair stand test while being assessed via video conferencing by a research team member to evaluate mobility.
Changes in The Activities-specific Balance Confidence Scale (ABC) questionnaire Baseline, mid-intervention at 6 months, and follow-up at 12 months The ABC questionnaire consists of 16 questions where the participants rate their confidence that they will not lose their balance or become unsteady while performing different activities. They need to rate 16 different activities from 0 to 100, 0 being not confident at all, and 100 being completely confident on their abilities to perform the activity.
Changes in The Short Physical Performance Battery (SPPB) Baseline, mid-intervention at 6 months, and follow-up at 12 months The SPPB is an objective assessment tool for evaluating lower extremity functioning in older adults. Score ranges from 0 to 12. 0 being frail (disabled), and 12 being no mobility disability issues.
Trial Locations
- Locations (8)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
University of New Brunswick
🇨🇦Fredericton, New Brunswick, Canada
St. Joseph's Health Care London, Parkwood Hospital
🇨🇦London, Ontario, Canada
University of Ottawa
🇨🇦Ottawa, Ontario, Canada
Baycrest Academy for Research and Education
🇨🇦Toronto, Ontario, Canada
University of Waterloo
🇨🇦Waterloo, Ontario, Canada
Concordia University
🇨🇦Montréal, Quebec, Canada