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

NCT ID: NCT05375513

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2026-12-30

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SYNERGIC 2

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

Group Type: ACTIVE_COMPARATOR

PMI@Home

Intervention Type: OTHER

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.

Brain Health PRO (BHPro)

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

Group Type: PLACEBO_COMPARATOR

Brain Health Pro

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Ages 60-85 years.

2. Having mild cognitive impairment (MCI) defined as meeting all of the following:

1. Presence of subjective memory complaints from the participant and/or informant.

2. Objective impairment on cognitive tests independent of outcome measures.†

3. 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.

4. 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 /or Clinical Dementia Rating Scale (CDR) =0.5

3. 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 (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score >7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking).

4. 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).

5. Self-reported levels of proficiency in English for speaking and understanding spoken and written language.

6. Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen.

7. 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.

8. Able to comply with virtual visits, treatment plan, and trial-related activities.

9. Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ).

Exclusion Criteria

1. Having a diagnosis of dementia (based on DSM-IV criteria).

2. 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, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual severe motor deficits (i.e., stroke with motor deficit), or presence of unstable (non-controlled e.g., symptoms that suggest instability or no treatment for their condition) chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) that may preclude the participant from engaging properly with the trial interventions, or advanced-stage active cancer that at the study physician's discretion will prevent them from participating.

3. 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 study.

4. Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions.

5. Recent (in the past 12 months) and/or current substance or alcohol abuse.

6. 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.

7. Intention to enroll in other interventional clinical trials during same time.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manuel Montero-Odasso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care London, Parkwood Hospital

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: RECRUITING

University of New Brunswick

Fredericton, New Brunswick, Canada

Site Status: RECRUITING

St. Joseph's Health Care London, Parkwood Hospital

London, Ontario, Canada

Site Status: RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

Site Status: RECRUITING

Baycrest Academy for Research and Education

Toronto, Ontario, Canada

Site Status: RECRUITING

University of Waterloo

Waterloo, Ontario, Canada

Site Status: RECRUITING

Concordia University

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Diana Amaris

Role: CONTACT

Diana.Amaris@sjhc.london.on.ca

519-646-6100 ext. 45629

Frederico Faria, PhD

Role: CONTACT

Frederico.Faria@sjhc.london.on.ca

519-646-6100

Facility Contacts

Dr. Richard Camicioli

Role: primary

Dr. Chris McGibbon

Role: primary

Manuel Montero Odasso, MD, PhD

Role: primary

mmontero@uwo.ca

(519) 685-4292 ext. 42179

Manuel Montero Odasso, MD, PhD

Role: backup

Dr. Sarah Fraser

Role: primary

Dr. Howard Chertkow

Role: primary

Dr. Laura Middleton

Role: primary

Dr. Karen Li

Role: primary

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Other Identifiers

3948

Identifier Type: -

Identifier Source: org_study_id