Memory Support System for Mild Cognitive Impairment

Overseen By Johanna Fievre

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bruyere Research Institute

Disqualifiers: Visual/hearing impairment, Reading disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners

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 requires that any nootropic (memory-enhancing drug) intake has been stable for at least 3 months.

What data supports the effectiveness of the treatment Memory Support System for Mild Cognitive Impairment?

Research shows that the Memory Support System (MSS), a calendar and organization tool, helps people with mild cognitive impairment (MCI) improve their memory skills. Participants in studies were able to learn and use the system effectively, with many continuing to use it long-term, reporting better independence and mood. ^{1 2 3 4 5}

Is the Memory Support System safe for humans?

The Memory Support System (MSS) has been used in studies with people who have mild cognitive impairment, and no safety concerns have been reported. Participants were able to use the system effectively, and it helped improve their independence and mood. ^{1 2 6 7 8}

How does the Memory Support System treatment differ from other treatments for mild cognitive impairment?

The Memory Support System (MSS) is unique because it is a non-drug treatment that uses a calendar and organization system with a structured training program to help individuals with mild cognitive impairment manage memory loss. Unlike other treatments, it focuses on teaching compensatory strategies to improve functional ability, independence, and self-confidence. ^{1 2 3 5 9}

Research Team

Neil Thomas, MD

Principal Investigator

Bruyere Research Institute

Octavio Santos, PhD

Principal Investigator

Ottawa Hospital Research Institute, Bruyere Research Institute

Eligibility Criteria

This study is for individuals with mild cognitive impairment who have a care partner they see at least twice a week. They should have certain scores on dementia and cognitive assessments, and not be taking or changing doses of memory drugs for the last 3 months. People can't join if they're in another similar trial or have visual/hearing issues that would affect using the Memory Support System.

Inclusion Criteria

I have been diagnosed with mild cognitive impairment.

Clinical Dementia Rating global (CDR) score of ≤ 0.5

Montreal Cognitive Assessment score of ≥18

Exclusion Criteria

Concurrent participation in another related clinical trial

Visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survey and Enrollment

Participants with MCI complete a survey and are enrolled in the MSS training

1-2 weeks

1 visit (virtual or in-person)

MSS Training

Participants undergo MSS training consisting of ten 1-hour sessions delivered over two or six weeks

2-6 weeks

10 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of adherence, IADLs, self-efficacy, quality of life, mood, anxiety, and caregiver burden

8 weeks

2 visits (in-person or virtual)

Treatment Details

Interventions

• Memory Support System

Trial Overview The study tests how well a Memory Support System works when given to patients with mild cognitive impairment at an Ontario clinic. It looks into patient interest, best ways to deliver the system, costs of implementation, and its impact on daily activities, confidence in memory abilities, life quality, mood, anxiety levels, and caregiver stress.

Participant Groups

Group I: Memory Support System participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bruyere Research Institute

Lead Sponsor

Trials

35

Recruited

2,024,000+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Findings from Research

The Memory Support System (MSS) was successfully learned and utilized by 20 participants with amnestic mild cognitive impairment (MCI), with 95% compliance at the end of training and 89% at follow-up.

Participants showed a medium effect size in improved functional ability, along with reported benefits in independence, self-confidence, and mood, indicating that the MSS may effectively help manage memory loss symptoms in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. Greenaway, MC., Hanna, SM., Lepore, SW., et al.[2022]

In a study of 215 older adults with amnestic mild cognitive impairment (aMCI), better global cognition was found to predict how well individuals learned to use the Memory Support System (MSS) during a two-week training period.

Successful learning of the MSS was linked to higher adherence rates to the system at 6, 12, and 18 months after training, suggesting that early intervention with compensatory strategies could enhance long-term adherence for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. De Wit, L., Chandler, M., Amofa, P., et al.[2022]

The Memory Support System (MSS) training significantly improved adherence and functional ability in individuals with amnestic mild cognitive impairment (MCI), with benefits lasting up to 8 weeks after the intervention.

Care partners of individuals who received MSS training reported improved mood and reduced caregiver burden, while those in the control group experienced worsening burden, highlighting the broader positive impact of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. Greenaway, MC., Duncan, NL., Smith, GE.[2022]

The occupational therapy memory strategy education group (MSEG) significantly improved memory performance and quality of life in participants with varying levels of memory impairment, as evidenced by notable improvements on the Rivermead Behavioural Memory Test and a dementia quality of life measure after a six-week program.

Participants also reported increased use of external memory aids and higher satisfaction with their performance, with these positive effects maintained at a 3-month follow-up, highlighting the effectiveness of occupational therapy in supporting memory management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of An Occupational Therapy Memory Strategy Education Group Intervention on Irish Older Adults' Self-Management of Everyday Memory Difficulties. Coe, Á., Martin, M., Stapleton, T.[2019]

In a 12-week study involving five participants with memory impairments, an electronic memory aid significantly improved the completion of everyday activities and enhanced overall satisfaction and quality of life, although it did not improve memory function itself.

Technical issues with the memory aid highlighted the importance of reliability in such devices, suggesting that ongoing support and follow-up are crucial for maximizing their effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support in everyday activities with a home-based electronic memory aid for persons with memory impairments. Boman, IL., Bartfai, A., Borell, L., et al.[2010]

The MindMate application significantly improved memory performance in two out of three participants with Alzheimer's disease, as shown by a Tau-U analysis indicating a strong effect (Tau-U = 1, p < .01).

Despite its effectiveness, one participant withdrew due to usability issues, highlighting the importance of user-friendly design in memory aids for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MindMate: A single case experimental design study of a reminder system for people with dementia. McGoldrick, C., Crawford, S., Evans, JJ.[2021]

The HABIT® program, which includes various interventions like wellness education and yoga, significantly improves quality of life and mood for individuals with mild cognitive impairment (pwMCI), especially when wellness education is included.

Cognitive training (CCT) was found to have the most substantial effect on cognitive function, while yoga improved functional status and reduced caregiver burden, suggesting that a combination of these interventions tailored to patient preferences could optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. Levy, SA., Smith, G., De Wit, L., et al.[2023]

The Japanese version of the Rivermead Behavioural Memory Test (RBMT) effectively evaluates everyday memory function in patients with mild Alzheimer's disease, showing strong correlations with established cognitive assessment tools like the ADAS-J Cog and WMS-R.

The RBMT demonstrated high diagnostic accuracy, correctly classifying 98% of Alzheimer's patients and 96% of healthy individuals, making it a reliable tool for distinguishing between these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Validity of the Japanese version of Rivermead Behavioural Memory Test for evaluation of everyday memory function in patients with mild Alzheimer's disease]. Matsuda, A., Kazui, H., Hirono, N., et al.[2022]

In a randomized control trial with 143 participants aged 8 to 83, a paging system significantly improved everyday activities for over 80% of users, helping them manage tasks like self-care and medication.

The benefits of using the pager were not only immediate but also persisted for 7 weeks after participants stopped using it, indicating lasting improvements in memory and planning for individuals with brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing everyday memory and planning problems by means of a paging system: a randomised control crossover study. Wilson, BA., Emslie, HC., Quirk, K., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A behavioral rehabilitation intervention for amnestic mild cognitive impairment. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Memory Support System training in mild cognitive impairment: Predictors of learning and adherence. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effects of An Occupational Therapy Memory Strategy Education Group Intervention on Irish Older Adults' Self-Management of Everyday Memory Difficulties. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Support in everyday activities with a home-based electronic memory aid for persons with memory impairments. [2010]

6. England pubmed.ncbi.nlm.nih.gov

MindMate: A single case experimental design study of a reminder system for people with dementia. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. [2023]

8. Japan pubmed.ncbi.nlm.nih.gov

[Validity of the Japanese version of Rivermead Behavioural Memory Test for evaluation of everyday memory function in patients with mild Alzheimer's disease]. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Reducing everyday memory and planning problems by means of a paging system: a randomised control crossover study. [2019]