Home-Based Multifaceted Intervention for Mild Cognitive Impairment

(SYN2 Trial)

Recruiting at 8 trial locations

Overseen By Dr. Laura Middleton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must not be taking: Benzodiazepines, Neuroleptics

Disqualifiers: Dementia, Major depression, Schizophrenia, Severe anxiety, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 months

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based program called SYNchronizing, Exercises and Remedies to GaIn Cognition@Home. It aims to help people with mild cognitive impairment (MCI) improve brain health and potentially delay dementia. The program provides personalized guidance on physical exercise, mental activities, sleep, diet, and heart health management, all through an online platform. It suits those who have noticed memory issues, meet specific cognitive criteria, and have at least one other risk factor, such as low physical activity or poor diet. Participants need internet access and should be comfortable using technology like email and video calls. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive health strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who regularly use certain drugs like Benzodiazepines or neuroleptics. It's best to discuss your specific medications with the trial team.

What prior data suggests that this personalized multidomain intervention is safe for individuals with mild cognitive impairment?

Research has shown that lifestyle changes, such as exercising and eating well, can safely and effectively boost brain health in people with mild cognitive impairment (MCI). The SYNERGIC-2 program combines activities like physical exercise, brain training, healthy eating, good sleep, and heart health management to enhance thinking skills in older adults with MCI.

Past studies found that lifestyle programs like SYNERGIC-2 are generally easy for participants to handle, with few side effects reported. This indicates the program is safe for most participants. Since the program can be done at home, it allows participants to proceed at their own pace, reducing any discomfort.

Overall, evidence suggests that this type of program is a safe choice for those aiming to improve brain health and slow the progression of dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home-Based Multifaceted Intervention for Mild Cognitive Impairment because it offers a holistic, personalized approach that can be conveniently conducted at home. Unlike standard treatments, which often focus separately on physical exercise, cognitive training, or medication, this intervention synchronizes multiple elements like exercise, cognitive training, diet, sleep, and vascular risk factors into a cohesive program. This comprehensive approach, tailored to individual needs, may enhance cognitive function more effectively by addressing various lifestyle factors simultaneously. Additionally, the convenience of home-based, one-on-one coaching makes it accessible and sustainable for participants, potentially leading to better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?

Research has shown that personalized lifestyle changes can improve brain health in people with mild cognitive impairment (MCI). In this trial, the SYNERGIC-2 arm includes a mix of activities such as exercise, brain games, healthy eating, better sleep, and heart health management, all tailored for each person and conducted at home. Early results suggest these activities can enhance thinking skills and help maintain independence. The Brain Health PRO (BHPro) arm serves as a comparator with an educational program covering similar topics. Some studies indicate that focusing on lifestyle and heart health could prevent up to 40% of dementia cases. Similar approaches have demonstrated improvements in thinking and movement, making this method promising for those at risk of dementia. ^{1 2 3 4 5}

Who Is on the Research Team?

Manuel Montero-Odasso, MD, PhD

Principal Investigator

St. Joseph's Health Care London, Parkwood Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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), 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 ≥2 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 (Insomnia Severity Index (ISI) score ≥15), 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, 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)

I am between 60 and 85 years old.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month home-based personalized multidomain lifestyle intervention targeting physical exercise, cognitive training, diet, sleep, and vascular risk factors.

12 months

Regular virtual visits for coaching and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SYNchronizing, Exercises and Remedies to GaIn Cognition@Home

Trial Overview 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.

How Is the Trial Designed?

Group I: SYNERGIC 2 Active Control 1 Intervention

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

Group II: Brain Health PRO (BHPro) Placebo Group 1 Intervention

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

SYNchronizing, Exercises and Remedies to GaIn Cognition@Home is already approved in Canada for the following indications:

Approved in Canada as SYNERGIC-2 Trial for:

• Prevention of dementia in individuals with Mild Cognitive Impairment (MCI)

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Published Research Related to This Trial

A 12-week sport stacking intervention showed significant improvements in cognitive function, particularly in immediate recall memory, for individuals with mild Alzheimer's disease (AD) and mild cognitive impairment (MCI), with a notable effect size (Cohen d = 0.66).

The intervention also led to increased levels of plasma brain-derived neurotrophic factor (BDNF), suggesting a potential mechanism for the cognitive benefits observed, especially in participants with MCI who experienced the most significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sport Stacking on Cognition in Patients With Mild Alzheimer's Disease and MCI: Preliminary Findings of Randomized Controlled Trial. Yang, Z., Yang, J., Yu, DSF., et al.[2023]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

The MAXCOG intervention, a home-based cognitive rehabilitation program, significantly improved goal performance and satisfaction for clients with mild cognitive impairment (MCI) or early dementia, as shown in a randomized controlled trial with 55 client-supporter dyads.

Out of the participants, 25 dyads completed the MAXCOG sessions, demonstrating that personalized interventions can effectively address individual goals, leading to better outcomes compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAXCOG-Maximizing Cognition: A Randomized Controlled Trial of the Efficacy of Goal-Oriented Cognitive Rehabilitation for People with Mild Cognitive Impairment and Early Alzheimer Disease. Regan, B., Wells, Y., Farrow, M., et al.[2022]

In a clinical trial involving 175 older adults with mild cognitive impairment (MCI), a multidomain intervention combining aerobic-resistance exercises and computerized cognitive training significantly improved cognitive function compared to a control group, suggesting potential benefits in delaying dementia onset.

Vitamin D supplementation did not show any significant effect on cognitive improvement, indicating that the benefits observed were primarily due to the exercise and cognitive training components of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Exercise Alone or Combined With Cognitive Training and Vitamin D Supplementation to Improve Cognition in Adults With Mild Cognitive Impairment: A Randomized Clinical Trial. Montero-Odasso, M., Zou, G., Speechley, M., et al.[2023]

In a study involving 57 patients with amnestic mild cognitive impairment (aMCI), a 12-week home-based cognitive intervention (HCI) significantly improved cognitive function, particularly in verbal fluency as measured by the Controlled Oral Word Association Test (COWAT).

Despite the cognitive improvements, the study did not find significant changes in brain metabolism as measured by 18F-FDG PET imaging, suggesting that while HCI can enhance cognitive abilities, it may not immediately affect underlying brain metabolic processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 12-week home-based cognitive training on cognitive function and brain metabolism in patients with amnestic mild cognitive impairment. Park, J., Kim, SE., Kim, EJ., et al.[2022]

A 12-week SMARTfit dual-task training program for older adults with mild cognitive impairment led to significant improvements in cognitive tests (Trail-Making Test and Stroop Test) and physical performance (Short Physical Performance Battery).

Participants in the program reported a positive training experience, suggesting that community-based interventions like SMARTfit could be beneficial for preserving cognitive and physical function in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMARTfit Dual-Task Exercise Improves Cognition and Physical Function in Older Adults With Mild Cognitive Impairment: Results of a Community-Based Pilot Study. Jhaveri, S., Romanyk, M., Glatt, R., et al.[2023]

The COCOA trial is a two-arm randomized controlled trial designed to test the effectiveness of personalized multimodal lifestyle interventions, including diet, cognitive training, and exercise, in altering the cognitive decline trajectory in individuals with Alzheimer's disease and related dementias over a 2-year period.

The trial aims to demonstrate that data-driven remote coaching can enhance compliance and personalize interventions, potentially leading to improved cognitive outcomes, particularly for those in the early stages of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design. Roach, JC., Hara, J., Fridman, D., et al.[2023]

This study aims to evaluate the efficacy of a standardized herbal formula, Sailuotong (SLT), over 12 weeks in improving cognition in older adults with mild cognitive impairment (MCI), a condition that increases the risk of dementia.

The trial will also investigate SLT's mechanisms of action through various measures, including EEG and brain blood flow, while ensuring safety in a cohort of 80 participants, highlighting the need for new treatments for MCI as current pharmaceutical options have shown poor results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment. Steiner, GZ., Bensoussan, A., Liu, J., et al.[2019]

A pilot study involving 47 participants with mild cognitive impairment showed that intensive, computer-based cognitive training improved neuropsychological assessment scores by 0.36 standard deviations, although this was not statistically significant compared to the control group.

The study suggests that while the cognitive training may have specific benefits for verbal learning and memory, further research with larger sample sizes is needed to confirm these effects and explore their potential domain-specific impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Barnes, DE., Yaffe, K., Belfor, N., et al.[2022]

In a 24-week trial involving 324 patients with amnestic mild cognitive impairment (aMCI), herbal therapy significantly improved cognitive function, showing a mean decrease of 4.23 points on the ADAS-cog scale, comparable to the effects of donepezil.

The herbal therapy was associated with fewer adverse events compared to donepezil, indicating it is a safer and well-tolerated treatment option for patients with aMCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an Herbal Therapy in Patients with Amnestic Mild Cognitive Impairment: A 24-Week Randomized Phase III Trial. Tian, J., Shi, J., Li, T., et al.[2020]

Nootropics, particularly L-a-glyceryl-phosphoryl-ethanolamine (L-a GPE), show promise in preserving cognitive function in patients with mild cognitive impairment (MCI) by targeting brain pathways related to neurotransmitters and promoting neuronal health.

L-a GPE acts as a precursor for phospholipids and an acetylcholine donor, potentially countering age-related cognitive decline by enhancing cognitive reserve and protecting against neuronal loss and oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function modulation during aging: a focus on L-alpha-GPE. Biggio, G., Di Fazio, I., Martini, C.[2022]

A new cognitive composite measure, ADAS-Cog-Exec, was developed for the EXERT trial, which is a 12-month exercise intervention study aimed at individuals with mild cognitive impairment (MCI).

This composite measure showed higher sensitivity to detect changes in cognitive function over 12 months compared to the traditional ADAS-Cog13 total score, making it a more effective primary outcome for assessing the impact of exercise on cognitive decline in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel cognitive composite outcome to assess therapeutic effects of exercise in the EXERT trial for adults with MCI: The ADAS-Cog-Exec. Jacobs, DM., Thomas, RG., Salmon, DP., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05375513

Study Details | NCT05375513 | SYNERGIC-2 Trial ... SYNERGIC-2 is the first large Canadian clinical trial using a 12-month home-based personalized multidomain lifestyle intervention to improve cognition in 550 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05375513/synergic-2-trial-synchronizing-exercises-and-remedies-to-gain-cognitionhome

SYNERGIC-2 Trial (SYNchronizing, Exercises and ... SYNERGIC-2 is the first large Canadian clinical trial using a 12-month home-based personalized multidomain lifestyle intervention to improve cognition in 550 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5902955/

SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in ... The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility ...

4. tdra.utoronto.ca tdra.utoronto.ca/study/synchronizing-exercises-and-remedies-gain-cognition

Synchronizing, Exercises and Remedies to Gain Cognition SYNERGIC-2 is a 12-month personalized, home-based lifestyle intervention to improve cognition in older adults with Mild Cognitive Impairment (MCI). The ...

5. clinicaltrial.be clinicaltrial.be/fr/details/17098?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

SYNERGIC-2 Trial (SYNchronizing, Exercises and ... These personalized at-home interventions target 5 domains with tailored physical exercise, cognitive training, diet recommendations, sleep ...