Recruiting

Cognition@Home

Sponsor:

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

Code:

NCT05375513

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

PMI@Home

Brain Health Pro

Study Details

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

Study ID

NCT05375513

Start date

Jun 5, 2023

Status verified date

Aug, 2024

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: SYNERGIC 2

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

placebo comparator: Brain Health PRO (BHPro)

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

Interventions

PMI@Home

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.

Brain Health Pro

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

Primary outcome measure

  • Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13) [ Time Frame: baseline and at 48 weeks (after interventions finalized) ]

Central Contacts and Locations

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada

University of New Brunswick

Recruiting

Fredericton, New Brunswick, Canada

St. Joseph's Health Care London, Parkwood Hospital

Recruiting

London, Ontario, Canada, N6C5J1

Contacts

Manuel Montero Odasso, MD, PhD

(519) 685-4292mmontero@uwo.ca

University of Ottawa

Recruiting

Ottawa, Ontario, Canada

Baycrest Academy for Research and Education

Recruiting

Toronto, Ontario, Canada

University of Waterloo

Recruiting

Waterloo, Ontario, Canada

Concordia University

Recruiting

Montréal, Quebec, Canada

More Information

Sponsor

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

Last update posted

Oct 29, 2024

Last verified

Aug, 2024

Keywords

  • Dementia
  • Mild Cognitive Impairment
  • Virtual Interventions
  • Geriatric Medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-10-29.