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New treatment option for Mild Cognitive Impairment
Official title SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@home)
ClinicalTrials.gov ID: NCT05375513
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Ages 60-85 years.
- Having mild cognitive impairment (MCI) defined as meeting all of the following:
- Presence of subjective memory complaints from the participant and/or informant.
- Objective impairment on cognitive tests independent of outcome measures.†
- Preserved activities of daily living assessed (\>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based...
You likely can't join if
- Having a diagnosis of dementia (based on DSM-IV criteria).
- Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression...
- Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's...
- Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and...
- Recent (in the past 12 months) and/or current substance or alcohol abuse.
- Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollment in the clinical trial that according to the...
See the full eligibility criteria
- Ages 60-85 years.
- Having mild cognitive impairment (MCI) defined as meeting all of the following:
- Presence of subjective memory complaints from the participant and/or informant.
- Objective impairment on cognitive tests independent of outcome measures.†
- Preserved activities of daily living assessed (\>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities.
- Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and...
- Have ≥1 additional dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet...
- Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences).
- Self-reported levels of proficiency in English for speaking and understanding spoken and written language.
- Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen.
- Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance.
- Able to comply with virtual visits, treatment plan, and trial-related activities.
- Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ).
- Having a diagnosis of dementia (based on DSM-IV criteria).
- Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression (Geriatric Depression Scale (GDS-30) \>19), schizophrenia, severe anxiety...
- Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the...
- Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions.
- Recent (in the past 12 months) and/or current substance or alcohol abuse.
- Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollment in the clinical trial that according to the study physician may preclude physical activity performance.
- Intention to enroll in other treatment clinical trials during same time.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Fredericton, New Brunswick, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Waterloo, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Fredericton, New Brunswick, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.