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Home-based program of exercise, diet and sleep care for mild cognitive impairment

Tests a personalized home program for people with mild cognitive impairment.

Key facts

Who runs it
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Where
Canada8 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
SYNERGIC-2 Trial (SYNchronizing, Exercises and Remedies to GaIn Cognition@Home)
Status
Recruiting
People taking part
250 people, planned
Started
5 Jun 2023
Expected to end
30 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • PMI@Home
  • Brain Health Pro
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 60-85 with mild cognitive impairment (MCI) and at least 1 dementia risk factor. The program is done at home, online.

Age
60 to 85 years
Sex
All sexes
Disease stage
Mild cognitive impairment: memory complaints, low scores on memory and thinking tests, daily activities still managed, no dementia. Examples: MoCA score between 16 and 25, RAVLT delayed recall ≤6, or CDR =0.5.
Biomarker or test result
At least 1 risk factor: less than 150 minutes of exercise per week, poor diet (MDA-14 score ≤7), sleep problems (ISI score >7), or heart and blood vessel risk (CAIDE score ≥6, diabetes, BMI≥30, high blood pressure, or smoking).

Main reasons for not taking part

  • A diagnosis of dementia.
  • Severe illness that stops taking part, such as major depression, schizophrenia, severe anxiety, parkinsonism, stroke with movement problems, uncontrolled heart failure or COPD, or advanced active cancer.
  • Surgery in the last 2 months, or planned surgery in the next 12 months that could affect taking part.
  • Regular use of benzodiazepine or neuroleptic drugs, or drug or alcohol abuse in the past 12 months or now.
  • A severe heart attack in the 6 months before joining, or plans to join other interventional trials.

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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 at least 1 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)

Who cannot take part

  • 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
  • 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
  • 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
  • Recent (in the past 12 months) and/or current substance or alcohol abuse
  • Intention to enroll in other interventional clinical trials during same time

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 60 and 85 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • SYNERGIC 2Existing treatment, for comparison

    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

    Treatment: PMI@Home

  • Brain Health PRO (BHPro)Placebo, for comparison

    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

    Treatment: Brain Health Pro

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Home-based Personalized Multidomain RCT From the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)
Plain-language title
Home-based program of exercise, diet and sleep care for mild cognitive impairmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT05375513, who can take part
Record updated
21 September 2026