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Home-Based Multifaceted Intervention for Mild Cognitive Impairment (SYN2 Trial)

N/A
Recruiting
Led By Manuel Montero-Odasso, MD, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 60-85 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, mid-intervention at 6 months, and follow-up at 12 months
Awards & highlights

SYN2 Trial Summary

This trial offers a "personalized tailored intervention" for adults with MCI that includes physical and cognitive training, sleep, diet, and vascular-metabolic interventions delivered at home via a virtual platform. The goal is to reduce dementia incidence by even a modest amount, saving billions in healthcare costs over 30 years.

Who is the study for?
The SYNERGIC-2 trial is for adults aged 60-85 in Canada with Mild Cognitive Impairment (MCI) who have memory complaints, some objective cognitive impairment but no dementia. Participants should be able to use email and a computer, speak and understand English, have good vision and hearing, engage in virtual visits, and perform daily activities independently. They must also have at least two additional risk factors like low physical activity or poor diet.Check my eligibility
What is being tested?
This trial tests a 'personalized multidomain intervention' called PMI@Home combined with Brain Health Pro software. It aims to improve brain health by addressing lifestyle factors such as exercise, sleep, diet, and vascular-metabolic issues through home-based virtual platforms to potentially delay the onset of dementia.See study design
What are the potential side effects?
Since this study involves non-pharmaceutical interventions focusing on lifestyle changes delivered virtually at home there are minimal expected side effects. However, participants may experience fatigue or discomfort from new exercises or dietary changes.

SYN2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 60 and 85 years old.

SYN2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, mid-intervention at 6 months, and follow-up at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-intervention at 6 months, and follow-up at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
Secondary outcome measures
Change in Anthropometric Measures
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia
Change in Geriatric Depression Scale (GDS-30)
+27 more
Other outcome measures
Adverse Events
Age of Participant
Assessment Tolerability
+6 more

SYN2 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SYNERGIC 2Active Control1 Intervention
Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors Control
Group II: Brain Health PRO (BHPro)Placebo Group1 Intervention
Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors Social engagement

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,219 Total Patients Enrolled
Manuel Montero-Odasso, MD, PhDPrincipal InvestigatorSt. Joseph's Health Care London, Parkwood Hospital

Media Library

SYNchronizing, Exercises and Remedies to GaIn Cognition@Home Clinical Trial Eligibility Overview. Trial Name: NCT05375513 — N/A
Mild Cognitive Impairment Research Study Groups: SYNERGIC 2, Brain Health PRO (BHPro)
Mild Cognitive Impairment Clinical Trial 2023: SYNchronizing, Exercises and Remedies to GaIn Cognition@Home Highlights & Side Effects. Trial Name: NCT05375513 — N/A
SYNchronizing, Exercises and Remedies to GaIn Cognition@Home 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375513 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals currently able to enroll in this experiment?

"Clinicaltrials.gov affirms that this research endeavour is no longer enrolling patients, having been initially posted on June 1st 2022 and last modified on May 10th 2022. However, there are 572 other trials currently in need of volunteers at present."

Answered by AI

What qualifications must someone meet in order to join this research endeavor?

"This trial is seeking 275 individuals aged 60-85 who have experienced some degree of cognitive decline. The primary criteria include: being in the specified age group with subjective memory complaints, meeting MoCA and Clinical Dementia Rating Scale scores, engaging in low physical activity or having an unsatisfactory diet (MDA-14≤7), insomnia (ISI≥15) and vascular/metabolic risk (CAIDE ≥6). Additionally, selected candidates must possess adequate English proficiency as well as be able to access emails on a computer device; they should also have preserved activities of daily living (>14/23 Lawton-Brody scale"

Answered by AI

Are older individuals being excluded from this research project?

"This research project has a strict age range for participants; the minimum is 60 and the maximum is 85."

Answered by AI
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~183 spots leftby Nov 2025