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

NCT05375513 | Recruiting

• 1 other identifier: 3948
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 8

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.

Conditions

Mild Cognitive Impairment

Keywords

Dementia; Mild Cognitive Impairment; Virtual Interventions; Geriatric Medicine

Outcome Measures

Primary Outcomes (1)

• Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)

  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.

  baseline and at 48 weeks (after interventions finalized)

Secondary Outcomes (30)

• Change in Anthropometric Measures

  Baseline, month 3, mid-intervention at 6 months, month 9, 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 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 Digit Symbol Modalities Test - Oral Version (mental processing speed)

  Baseline, mid-intervention at 6 months, and follow-up at 12 months

Other Outcomes (9)

• Recruitment Rate

  Throughout study completion - avg. 12 months/participant

• Retention Rate

  Throughout study completion - avg. 12 months/participant

• Assessment Tolerability

  Baseline

Study Arms (2)

SYNERGIC 2

ACTIVE COMPARATOR

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

Other: PMI@Home

Brain Health PRO (BHPro)

PLACEBO COMPARATOR

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

Other: Brain Health Pro

Interventions

PMI@Home 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.

SYNERGIC 2

Brain Health Pro 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

Brain Health PRO (BHPro)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 /or Clinical Dementia Rating Scale (CDR) =0.5
• 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).
• 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).

You may not qualify 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 (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.
• 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.
• 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 interventional clinical trials during same time.

Sponsors & Collaborators

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

Study Sites (8)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

RECRUITING

University of New Brunswick

Fredericton, New Brunswick, Canada

RECRUITING

St. Joseph's Health Care London, Parkwood Hospital

London, Ontario, N6C5J1, Canada

RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

Baycrest Academy for Research and Education

Toronto, Ontario, Canada

RECRUITING

University of Waterloo

Waterloo, Ontario, Canada

RECRUITING

Concordia University

Montreal, Quebec, Canada

RECRUITING

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MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Manuel Montero-Odasso, MD, PhD

  St. Joseph's Health Care London, Parkwood Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Amaris

CONTACT

519-646-6100; Diana.Amaris@sjhc.london.on.ca

Frederico Faria, PhD

CONTACT

519-646-6100; Frederico.Faria@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The SYNERGIC-2 Trial is a single-blind, two-arm, randomized controlled trial (RCT) evaluating the cognitive effect of personalized multidomain interventions that target physical exercise, cognitive training, sleep, diet, and vascular risk factors. The SYNERGIC-2 Trial will be administered virtually through online video conferencing platform systems (WeBex or Zoom Healthcare©). Figure 1 illustrates the trial design. The trial adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for conducting and reporting clinical trials, as extended to non-pharmacological interventions. A total of 550 participants with MCI aged 60-85 will be enrolled and randomized into one of two arms, with 275 participants in each arm

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 16, 2022
• Study Start: June 5, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)