Memory Support System for Mild Cognitive Impairment

Recruiting at 1 trial location

Overseen By Fjolla Berbatovci

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Memory Support System designed to assist individuals with mild cognitive impairment (MCI), a condition affecting memory and thinking skills. The study aims to evaluate the system's effectiveness for patients and their caregivers in a clinic setting in Ontario. Researchers will assess its ease of use, impact on daily life, and potential to improve memory and mood. Individuals diagnosed with MCI who have regular contact with a caregiver may be suitable candidates for this trial. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance daily living for those with MCI.

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 prior data suggests that the Memory Support System is safe for individuals with mild cognitive impairment?

Research shows that the Memory Support System (MSS) helps people with mild memory problems by using a calendar or planner. Studies have found that MSS can positively impact users' daily lives.

The studies do not mention any side effects or safety concerns with MSS. Since it involves using a calendar and planner, it is generally safe and easy to use. Users have reported satisfaction, indicating that it is comfortable and user-friendly.

Overall, MSS appears to be a safe way to assist those with memory challenges, with no harmful effects reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Memory Support System is unique because it focuses on enhancing cognitive function through structured memory exercises rather than relying on medication. Unlike standard treatments for mild cognitive impairment, which often involve pharmaceuticals like cholinesterase inhibitors, the Memory Support System offers a non-drug approach that is less likely to have side effects. Researchers are excited about this trial because it explores the potential of behavioral interventions to improve memory and cognitive skills, potentially offering a safer and more sustainable management option for patients.

What evidence suggests that the Memory Support System is effective for mild cognitive impairment?

Studies have shown that the Memory Support System (MSS) can help people with mild cognitive impairment (MCI) by improving their memory skills for everyday tasks. This system uses simple tools like a calendar and planner, which have proven to make daily activities easier. In this trial, participants will use the MSS to assess its effectiveness. Care partners using MSS reported feeling happier over time, while those not using it felt more stressed. Research also found that people who used the MSS continued to use it regularly. Overall, MSS has supported memory and enhanced the quality of life for those with MCI. ^{1 2 3 4 6}

Who Is on the Research Team?

Neil Thomas, MD

Principal Investigator

Bruyère Health Research Institute.

Octavio Santos, PhD

Principal Investigator

Ottawa Hospital Research Institute, Bruyère Health Research Institute

Are You a Good Fit for This Trial?

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

I have a caregiver who checks on me at least twice a week.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Bruyère Health Research Institute.

Lead Sponsor

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3766962/

The Memory Support System for Mild Cognitive Impairment Care partners in the intervention group demonstrated improved mood by 8 week and 6 month follow-up, while control care partners reported worse caregiver burden ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8180362/

Memory Support System Training in Mild Cognitive ... This study aimed to identify predictors of learning and adherence to a previously validated compensatory calendar and note taking system (Memory Support System ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05999929

NCT05999929 | Memory Support System Feasibility Study The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.063432

The Learning of Memory Support System in Individuals with ... The Memory Support System (MSS), a memory-support tool which utilizes a calendar/planner, has been shown to have positive impact on daily ...

5. mdpi.com mdpi.com/3042-4518/2/3/26

Implementation of the Memory Support System for ... Implementation of the Memory Support System for Individuals with Mild Cognitive Impairment: A Feasibility Survey Study. by. Suraj Brar.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8372500/

Innovation Inspired by COVID: A Virtual Treatment Program ... This brief report provides patient and partner satisfaction data as well as clinical outcomes with a virtual adaptation of the HABIT program developed because ...