SYNERGIC 2 for Cognitive Decline

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Joseph's Health Care London, Parkwood Hospital, London, Canada
Cognitive Decline+1 More
PMI@Home - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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/cardiovascular factors.Given that current treatments cannot modify the disease, prevention is critical. SYNERGIC-2 offers a "personalized tailored 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.

Eligible Conditions

  • Cognitive Decline
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 23 Secondary · Reporting Duration: Baseline, mid-intervention at 6 months, and follow-up at 12 months

At coach interventions
Change in Rated Perceived Exertion-Borg Scale
Baseline
Age of Participant
Assessment Tolerability
Sex of Participant
Month 12
Change in Canadian Diet History Questionnaire
Changes in Cognitive Expectancy Questionnaire
Month 12
Change in Anthropometric Measures
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia
Change in Geriatric Depression Scale (GDS-30)
Change in Health Utility Index (HUI-3)
Changes in Clinical Dementia Rating scores
Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed)
Changes in Eating Pattern Self-Assessment
Changes in Fall Occurrence
Changes in Generalized Anxiety Disorder (GAD-7)
Changes in Health Resource Utilization Questionnaire (HRUQ)
Changes in Insomnia Severity Index
Changes in International Physical Activity Questionnaire scores
Changes in Quality of Life Questionnaire (SF-36)
Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory
Changes in Stroop test scores - Inhibitory cognitive capabilities
Changes in global cognitive function using Montreal Cognitive Assessment(MoCA)
Changes in the CCNA Gait Assessments results-Walking performance
Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
Changes in the Mediterranean Diet Assessment
Changes in the Oral Trail Making Test - Attention Shifting capabilities/executive functions using
Chronic Diseases of Participant
Medications Taken by Participant
Screening
Hearing Ability of Participants
Participant Ability to Partake in Exercise(GAQ-Short)
Month 12
Adverse Events
Data Loss
Recruitment Rate
Retention Rate
Week 48
Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

SYNERGIC 2
1 of 2
Brain Health PRO (BHPro)
1 of 2
Active Control
Non-Treatment Group

275 Total Participants · 2 Treatment Groups

Primary Treatment: SYNERGIC 2 · Has Placebo Group · N/A

SYNERGIC 2
Other
ActiveComparator Group · 1 Intervention: PMI@Home · Intervention Types: Other
Brain Health PRO (BHPro)
Other
PlaceboComparator Group · 1 Intervention: Brain Health Pro · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, mid-intervention at 6 months, and follow-up at 12 months
Closest Location: St. Joseph's Health Care London, Parkwood Hospital · London, Canada
Photo of ontario 1Photo of ontario 2Photo of ontario 3
2019First Recorded Clinical Trial
0 TrialsResearching Cognitive Decline
2 CompletedClinical Trials

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
607 Previous Clinical Trials
398,681 Total Patients Enrolled
Manuel Montero-Odasso, MD, PhDPrincipal InvestigatorSt. Joseph's Health Care London, Parkwood Hospital

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have regular access to email, you have a home computer and/or laptop computer device, and you are able to send and receive emails.
You are able to perform activities of daily living that are not dependent on others.
You have normal/corrected to normal vision in at least one eye.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References