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CompletedNCT05167045CTU BHSP-PUpdated Jan 16, 2026

A Pilot Study for the Brain Health Support Program

An observational study in Dementia, Mild Cognitive Impairment and Subjective Cognitive Impairment, sponsored by Baycrest. Completed at 3 sites in Canada. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Baycrest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
60 Years to 85 Years
Sex
All
01

Study summary

Prior studies have shown that programs that focus on promoting brain health and managing lifestyle risks (such as poor diet, obesity, physical inactivity, sleep issues, loneliness) may help in preventing or lowering the risk of dementia. To address this, investigators have developed the CAN-THUMBS UP program to conduct studies that target lifestyle risk and focus on dementia prevention. An online Brain Health Support Program (BHSP) has been developed. The BHSP is an educational program designed to teach about dementia. Before the full BHSP is offered to a large group, we are conducting an initial pilot study to help assess the usability of the program.

02

Conditions studied

  • Dementia
  • Mild Cognitive Impairment
  • Subjective Cognitive Impairment
  • Pre-dementia
  • Dementia Prevention
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 20 is below the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Baycrest is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

This study will recruit it's cohort from various locations around Canada.

Eligibility criteria

Inclusion Criteria:

  • Meets criteria for No Dementia and one of the following (according to CCNA criteria):

Cognitively Intact (CI) Cognitively Intact plus Subjective Cognitive Impairment (CI + SCI) Mild Cognitive Impairment (MCI)

  • AND Classified as being at increased risk of dementia based on at least one of the following: First-degree family history of dementia

Self-Reported or documented current and/or history at midlife (45-60) on any of the following risk factors:

  • Hypertension (documented Systolic Blood Pressure > 140 mm Hg; OR physician diagnosis of hypertension; OR treatment for hypertension; OR other approaches to treatment (e.g. diet, exercise))
  • Hypercholesterolemia (documented total cholesterol > 6.5 mmol/L; OR physician diagnosis of hypercholesterolemia; OR treatment for hypercholesterolemia; OR other approaches to treatment (e.g. diet, exercise))
  • Body Mass Index > 30 kg/m2 (derived from NIH Metric BMI Calculator)
  • Physical Inactivity (active is defined as engaging in a minimum of 20- 30 min of physical activity causing sweating and breathlessness, at least 2 times a week)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • No Dementia

    Behavioral: Brain Health PRO

Interventions

  • BehavioralBrain Health PRO

    The BHSP is an educational program designed to teach about dementia. It aims to provide best available evidence for lifestyle changes that can help lower dementia risk, and to provide specific recommendations for positive lifestyle changes (e.g., physical exercises to try at home, healthy recipes). The program was developed as a collaborative effort by Canadian investigators who have expertise in the different areas of dementia prevention, along with input from older-adult citizen advisors.

    Also known as: Brain Health Support Program

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What researchers measure

Primary outcomes

  1. Functionality of the BHSP

    Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions

    Time frame: Nov 2021-Mar 2022

  2. User acceptance of the BHSP

    User adherence and engagement using the online program during the pilot including dates and times of use, duration of use and completion of program assessments

    Time frame: Nov 2021-Mar 2022

  3. Usability of the BHSP

    User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)

    Time frame: Nov 2021-Mar 2022

  4. To assess participant satisfaction with the organization, presentation and personalization of the BHSP content

    Qualitative evaluation of participant responses during the focus group discussion

    Time frame: Nov 2021-Mar 2022

  5. To evaluate the feasibility of remote data collection

    User data, feedback and adherence to remote measures, such as: Screening evaluation by tele/video-conference, Neuropsychological Test Battery, Burst cognitive testing with the MyCogHealth app, online version of the Cogstate Brief Battery, Assessments of lifestyle risk factors (sleep, diet, mood, cognition, physical activity, vascular health, social and psychological health, vision and hearing), Actigraphy and EEG wearables as measures of total daily physical activity and sleep fragmentation, and Saliva sample collection for genomics testing (Polygenic Hazard Score)

    Time frame: Nov 2021-Mar 2022

07

Study locations

3 sites
  • University of British Columbia
    Vancouver, British Columbia V6T 1Z4, Canada
  • University of New Brunswick
    Fredericton, New Brunswick E3B 5A3, Canada
  • Baycrest
    Toronto, Ontario M6A 2E1, Canada
08

References and documents

Publications

  • Philip G, Fiocco AJ, Belleville S, Chertkow H, Feldman HH, Montero-Odasso M, Nygaard HB, Savundranayagam MY; Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Exploring the usability and perceived benefits of Brain Health PRO: An online educational program for healthy brain aging. Digit Health. 2025 Nov 19;11:20552076251395585. doi: 10.1177/20552076251395585. eCollection 2025 Jan-Dec. PubMed 41278371 ↗
  • Belleville S, Anderson ND, Bherer L, Camicioli R, Carrier J, Chan S, Cuesta M, Dang-Vu TT, Dwosh E, Fiocco AJ, Ferland G, Gilbert B, Harris E, Itzhak I, Jarrett P, Kadri MA, Laurin D, Liu-Ambrose T, McGibbon CA, Middleton L, Miller L, Nygaard HB, Montero-Odasso M, Murphy K, Phillips N, Pichora-Fuller MK, Robillard JM, Smith EE, Speechley M, Trigui A, Wittich W, Chertkow H, Feldman HH; CTU expert group for the Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Study Group. Brain health PRO/Sante cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction. J Prev Alzheimers Dis. 2025 Jun;12(6):100134. doi: 10.1016/j.tjpad.2025.100134. Epub 2025 Mar 15. PubMed 40090784 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05167045
Lead sponsor
Baycrest
Responsible party
Howard Chertkow (Scientific Director, Canadian Consortium on Neurodegeneration in Aging, Baycrest) — Principal investigator
First posted
Dec 22, 2021
Start date
Nov 15, 2021
Primary completion
Apr 29, 2022
Completion
Apr 29, 2022
Last update
Jan 16, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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