Mild Cognitive ImpairmentNCT05999929
Memory Support System Feasibility Study
A study testing Memory Support System in people with Mild Cognitive Impairment, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Memory Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 17 Dec 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of single or multi-domain MCI
- Clinical Dementia Rating global (CDR) score of ≤ 0.5
- Montreal Cognitive Assessment score of ≥18
- available contact with a care partner ≥ 2 times weekly
- absence or stable intake of nootropic(s) for ≥ 3 months
Who cannot join
- visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
- concurrent participation in another related clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Bruyère Health Research Institute
Ottawa, Ontario, K1H 5C8
Nayna Kirubakar, 613-562-6262 ext. 1266, nkirubakar@bruyere.org
Neil Thomas, MD, 613-562-6322, nthomas@bruyere.org
About this study
Official title: Implementation of the Memory Support System: A 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) 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
Read the detailed description
A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.
During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.
At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Memory Support System
- Keywords
- Cognition, Intervention, French
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Support SystemBehavioural
The MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment.
| Study group | Role | What they receive |
|---|---|---|
| Memory Support System participants | Experimental | Not described Receives: Behavioral: Memory Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest in completion of MSS training
Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.
Measured: From study start date up to 19 months.
Secondary outcomes (8)
Adherence to French Memory Support System Intervention
Change from adherence scores from one week after starting treatment (MSS intervention) at treatment end and at 8 weeks after the treatment end. Using an adherence scale from 0 to 10, with 10 being highest and a cut-off score of ≥ 7 points suggesting adherence with the MSS.
Measured: One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Center for Epidemiologic Studies Depression Scale
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Depression screening scale using Likert scale. Total score of 0-60 points, with higher scores signifying a worse outcome (higher levels of depression).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Everyday Cognition questionnaire.
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report measure of performance based instrumental activities of daily living. Total score of 23-92, with higher scores indicating a worse outcome.
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Functional Assessment Questionnaire
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based report of performance of instrumental activities of daily living. Total score of 0-30, with higher scores indicating a worse outcome (higher level of dependence).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Quality of Life in Alzheimer Disease
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report quality of life scale. Total score of 13-52, with higher scores indicating a better outcome (better quality of life).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report anxiety scale. Total score of 10-40 with higher scores indicating a worse outcome (higher level of anxiety).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Chronic Disease Self-efficacy Scale
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Selected questions related to memory and cognition from self report scale. Total score of 9-90 with higher scores indicating a better outcomes (higher feeling of self-efficacy).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Caregiver Burden Inventory Short-Form
Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based scale of level of caregiver burden. Total score of 0-48 with higher scores indicating a worse outcome (higher level of burden).
Measured: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start17 Dec 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Neil Thomas, MD, Principal investigator, Bruyère Health Research Institute.Octavio Santos, PhD, Principal investigator, Ottawa Hospital Research Institute, Bruyère Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999929
- Sponsor's protocol ID
- M16-23-024
- Status last verified
- Sep 2026
- First submitted
- 3 Aug 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Memory Support System: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05999929
- Acronym / sponsor ID
- M16-23-024
- Conditions
- Mild Cognitive Impairment
- Keywords
- Cognition, Intervention, French
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.
During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.
At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory Support System participants | Experimental | Behavioral: Memory Support System |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of single or multi-domain MCI
- Clinical Dementia Rating global (CDR) score of ≤ 0.5
- Montreal Cognitive Assessment score of ≥18
- available contact with a care partner ≥ 2 times weekly
- absence or stable intake of nootropic(s) for ≥ 3 months
Key exclusion criteria (2 listed)
- visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
- concurrent participation in another related clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Support SystemThe MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment. | Behavioural | Memory Support System participants |
Primary outcome
Interest in completion of MSS training
Time frame: From study start date up to 19 months.
Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.
8 secondary outcomes
Adherence to French Memory Support System Intervention
Time frame: One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Everyday Cognition questionnaire.
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Functional Assessment Questionnaire
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Quality of Life in Alzheimer Disease
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Chronic Disease Self-efficacy Scale
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Caregiver Burden Inventory Short-Form
Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Thomas, MD principal investigator
Bruyère Health Research Institute.
Octavio Santos, PhD principal investigator
Ottawa Hospital Research Institute, Bruyère Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Support System in people with Mild Cognitive Impairment, run by Bruyère Health Research Institute. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neil Thomas, MD (613-562-6322, nthomas@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest in completion of MSS training (time frame: From study start date up to 19 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.