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

Study acronym: SYN2
StatusRecruiting
PhaseNot applicable
Started2023-06-05
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Nov 30, 2025 → Nov 30, 2027
See other at-risk trials from London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Amendment history

2026-09-22
Primary completion pushed: 2025-11-30 → 2027-11-30
Completion pushed: 2026-12-30 → 2028-12-30
2024-10-25
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v5
Study sitesdetails revised at 2 of 8 sites
Study titlerevised
SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@Homehome)
2024-08-06
Study Status, Contacts/Locations v4
Study sitesdetails revised at 7 of 8 sites
2024-07-02
Study Status, Eligibility v3
Eligibility criteria+24 characters
[...] ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5 Have ≥21 additional dementia risk factors targeted by our interventi [...] Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score ≥15>7), and vascular-metabolic risk (Cardiovascular Risk Factors [...]
2024-02-26
Study Status v2
Primary completion date2023-11-30→2025-11-30
Completion date2024-12-30→2026-12-30
2023-10-30
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-06-01→confirmed 2023-06-05
Study sites1→8
Eligibility criteria+1,107 characters
Inclusion Criteria AgedAges 60-85 years. Having Mildmild Cognitivecognitive Impairmentimpairment (MCI) defined as meeting all of the following: Presence of subjective memory complaints from the participant and/or familyinformant. Objective impairment on cognitive tests independent of out [...] activities of daily living assessed (>14/23 in Lawton-Brody scaleIADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities. Absence of clinical dementia established usingper DSM-IV criteria †Objective cognitive impairment is operationalized as: [...]
Secondary endpoints23 to 30 entries
ChangeChanges in Ratedthe PerceivedCognitive Exertion-Borg Scale Change in Canadian Diet HistoryExpectancies Questionnaire Changes in Cognitivesleep Expectancy Questionnairepattern Changes in Stroopphysical testactivity scoresin the elderly Changes in behavior Changes in BHPro questionnaires Changes in EEG Identification of APO-E Inhibitoryvariants, cognitivea capabilitiesplanned panel of 31 single nucleotide polymorphisms (SNPs), and untargeted metabolomics Changes in Resource Use Inventory Q7 & Q8 (RUI Q7 &Q8) Changes in 60s Chair Standing Test Changes in The Activities-specific Balance Conf [...]
Study title+19 characters
SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@Home)
2022-05-10
Original filing
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.
Trial Details
NCT Number NCT05375513
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions Mild Cognitive Impairment
Enrollment 250 participants
Start Date 2023-06-05
Primary Completion 2027-11-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21