Personalized home interventions to improve cognition in older adults with mild cognitive impairment

A Home-based Personalized Multidomain RCT from the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)

This study tests whether a personalized home program that includes exercise, brain training, diet tips, and sleep help can improve thinking skills in older adults with mild cognitive impairment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 275 (estimated)
• Ages: 60 Years to 85 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Locations: 8 sites (Edmonton, Alberta and 7 other locations)
• Trial ID: NCT05375513 on ClinicalTrials.gov

What this trial studies

The SYNERGIC-2 trial aims to improve cognition in older adults with mild cognitive impairment (MCI) through a personalized, multidomain intervention delivered at home. This 12-month program combines physical exercise, cognitive training, dietary recommendations, sleep interventions, and management of vascular risk factors, all facilitated via a digital platform. Participants will receive one-on-one coaching through video-conference meetings, allowing for tailored support and engagement. The effectiveness of this intervention will be compared to an online educational program focused on brain health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 60-85 with mild cognitive impairment and at least one additional dementia risk factor.

Not a fit: Patients with clinical dementia or those who do not meet the criteria for mild cognitive impairment will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly enhance cognitive function and delay the onset of dementia in older adults.

How similar studies have performed: Other studies have shown promise in using multidomain lifestyle interventions for cognitive improvement, making this approach both relevant and potentially impactful.

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.

Where this trial is running

Edmonton, Alberta and 7 other locations

• University of Alberta — Edmonton, Alberta, 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, 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)

Study contacts

• Principal investigator: Manuel Montero-Odasso, MD, PhD — St. Joseph's Health Care London, Parkwood Hospital
• Study coordinator: Diana Amaris

Conditions: Mild Cognitive Impairment, Dementia, Virtual Interventions, Geriatric Medicine