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RecruitingNCT05999929Updated Sep 25, 2026

Memory Support System Feasibility Study

An interventional study of Memory Support System in Mild Cognitive Impairment, sponsored by Bruyère Health Research Institute.. Recruiting at 1 site in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Bruyère Health Research Institute. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Cognition
  • Intervention
  • French
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Memory Support System participants

    Behavioral: Memory Support System

Interventions

  • BehavioralMemory Support System

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From study start date up to 19 months.

Secondary outcomes

  1. 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.

    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.

  2. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  3. 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.

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  4. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  5. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  6. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  7. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

  8. 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).

    Time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.

06

Study locations

1 of 1 sites recruiting
  • Bruyère Health Research Institute
    Ottawa, Ontario K1H 5C8, Canada
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05999929
Lead sponsor
Bruyère Health Research Institute.
Collaborators
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Dec 17, 2023
Primary completion
Mar 31, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Neil Thomas, MD
Contact
nthomas@bruyere.org
613-562-6322
Nayna Kirubakar
Contact
nkirubakar@bruyere.org
613-562-6262 ext. 1266
Neil Thomas, MD
principal investigator · Bruyère Health Research Institute.
Octavio Santos, PhD
principal investigator · Ottawa Hospital Research Institute, Bruyère Health Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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