Dementia PreventionCTU: BHSPNCT05347966

Brain Health Support Program

A study testing Brain Health PRO in people with Dementia Prevention and Mild Cognitive Impairment, run by Baycrest at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 60 to 85 years
Conditions the study is for: Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment
What is being tested?: Brain Health PRO
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 354 participants
Where: 7 sitesCanada
Study dates: 6 Apr 2022to 19 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion and documentation of the electronic Informed Consent Process (from the participant)
Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)
Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
Ability to sit comfortably for a period of about 30 minutes
Ages 60-85

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Meets criteria for No Dementia and meet criteria [according to Canadian Consortium on Neurodegeneration in Aging (CCNA) Criteria, Appendix 1] of one of the following:
Cognitively Unimpaired (CU)
Cognitively Unimpaired plus Subjective Cognitive Impairment (CU + 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 years) on any of the following lifestyle 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)
Participant has a family physician or other healthcare provider and agrees to have the provider notified of participation in the study and incidental or other findings that may be clinically significant

Who cannot join

Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.
Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments
Individuals who have a clinical diagnosis of Dementia
Clinical Dementia Rating (CDR; telephone/video-conference administration) Score of >1
Total Score on the Montreal Cognitive Assessment (MoCA; video-conference administration) <13

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Canada7 sites

Cape Breton University
Cape Breton, Nova Scotia, B1M 1A2
University of New Brunswick
Fredericton, New Brunswick, E3B 5A3
Cognitive Clinical Research Group, Parkwood Research Institute
London, Ontario, N6C 5J1
Gait and Brain Laboratory, Parkwood Research Institute
London, Ontario, N6C 5J1
CRIUGM/ CIUSSS du Centre-Sud-de-l'Île-de-Montréal
Montreal, Quebec, H3W 1W5
Baycrest
Toronto, Ontario, M6A 2E1
University of British Columbia
Vancouver, British Columbia, V6T 1Z4

Other trials in Canada

About this study

Official title: The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention

The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP, or CTU) is a comprehensive and innovative program aimed to develop, implement and evaluate an interactive and compelling online educational Brain Health Support Program (BHSP) intervention, called Brain Health PRO (BHPro), with potential to positively influence dementia literacy, lifestyle risk factors, and scale-up to reach the broader Canadian public; enroll and retain a community-dwelling Platform Trial Cohort (PTC) of individuals at risk of dementia; and support an open platform trial to test a variety of multidomain interventions that might further benefit individuals at risk of dementia.

Conditions: Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment, Cognitive Change
Being tested: Brain Health PRO
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brain Health PROOther
Also called BHPro
BHPro is a 45-week, multidomain web-based formal educational program which has been designed to increase dementia literacy, convey best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health.

Study groups in NCT05347966
Study group	Role	What they receive
Brain Health PRO	Other	Not described Receives: Other: Brain Health PRO

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Dementia Literacy From Baseline to Month 12
The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is designed to assess knowledge about Alzheimer's Disease (AD) among laypeople, patients, caregivers, and professionals. This self-report questionnaire contains 30 true/false items. The total score is the sum of the scores from the 30 items, which is quantitative and ranges from 0-30, with a higher score indicating better knowledge about AD. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia.
Measured: 12 months

Secondary outcomes (4)

Change in Self-efficacy From Baseline to Month 12
Change in self-efficacy following participation in the study, as measured by the General Self-Efficacy Scale (GSE). The GSE measures perceived competence in dealing with a range of stressful or challenging situations. This self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). The total score is the sum of the scores for the 10 items, which is quantitative and ranges from 10-40, with a higher score indicating more self-efficacy. To aide interpretation, change in GSE scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -7.39 to +7.39. The greater the change in score, the greater the increase in self-efficacy.
Measured: 12 months
To Evaluate Usability of BHPro
Based on System Usability Scale (SUS). The SUS is an 11-item questionnaire with 5-point Likert scale. The total raw score ranges from 0-43 with a higher score indicating greater usability and satisfaction with Brain Health Pro.
Measured: 12 months
Number of Chapters Completed on BHPro
To evaluate engagement with Brain Health PRO, the number of chapters completed on BHPro was calculated. There is a total of 180 chapters (181 when orientation chapter is included) that are available on BHPro. The program allows participants to view 160 chapters (excluding the orientation chapter) when reaching week 45 (the intended length of the BHPro program). After 45 weeks, the remaining chapters that were still locked will become accessible for users interested in viewing all the program content. The range of chapters that could be completed on Brain Health PRo by participants is 1-181, with a higher number indicating higher engagement with the program.
Measured: 12 months
To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).
Based on Technology Acceptance Model Questionnaire. The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 202219 Apr 2024

First posted27 Apr 2022
Study start6 Apr 2022
Primary completion5 Jan 2024
Study completion19 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dementia PreventionStudies 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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 354 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05347966
Sponsor's protocol ID: CTU: BHSP
Acronym: CTU: BHSP
Status last verified: Apr 2025
First submitted: 14 Apr 2022
Last updated: 2 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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
Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, Durant J, Lupo JL, Revta C, Chan S, Cuesta M, Slack PJ, Winer S, Brewster PWH, Hofer SM, Lim A, Centen A, Jacobs DM, Anderson ND, Walker JD, Speechley MR, Zou GY, Chertkow H. Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study. J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65.
PubMed 37874110

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dementia Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia: Brain Health Support Program Intervention
ClinicalTrials.gov ID: NCT05347966
Acronym / sponsor ID: CTU: BHSP / CTU: BHSP
Conditions: Dementia Prevention, Mild Cognitive Impairment, Subjective Cognitive Impairment, Cognitive Change
Study type: Interventional
Recruitment status: Completed
Enrolment: 354 participants (actual)
Lead sponsor: BaycrestUniversity, hospital or other
Study start: 6 Apr 2022 (actual)
Primary completion: 5 Jan 2024 (actual)
Study completion: 19 Apr 2024 (actual)
First posted: 27 Apr 2022 (actual)
Results: Posted 2 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Brain Health PRO	Other	Other: Brain Health PRO

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Completion and documentation of the electronic Informed Consent Process (from the participant)
Sufficient proficiency in English or French to undergo remote clinical and neuropsychological assessment and participate in an online educational program.
Technical ability to participate in an online educational program and remote assessments (i.e. computer and internet access; ability to send and receive emails; ability to complete remote assessments)
Sufficient vision and hearing to participate in online educational program and to undergo remote clinical and neuropsychological testing
Ability to sit comfortably for a period of about 30 minutes

Key exclusion criteria (7 listed)

Participants who, in the opinion of the investigator, are not able to complete trial procedures remotely or adhere to the schedule of study assessments will be excluded from study participation.
Individuals where English or French is not sufficiently proficient for remote clinical assessment, neuropsychological testing and participation in an online educational program.
Participants who do not have sufficient vision and hearing for remote clinical assessment, neuropsychological testing participation in an online educational program
Individuals who do not have the technical ability to participate in an online educational program. Technical ability is defined as having computer and internet access; ability to send and receive emails; ability to participate in remote assessments
Individuals who have a clinical diagnosis of Dementia

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
Brain Health PROAlso: BHProBHPro is a 45-week, multidomain web-based formal educational program which has been designed to increase dementia literacy, convey best available evidence for lifestyle changes that can mitigate dementia risk, and foster engagement toward one's own brain health.	Other	Brain Health PRO

Primary outcome

Change in Dementia Literacy From Baseline to Month 12
Time frame: 12 months
The primary outcome will be change in dementia literacy following participation in the study, as measured by the Alzheimer's Disease Knowledge Scale (ADKS). The ADKS is designed to assess knowledge about Alzheimer's Disease (AD) among laypeople, patients, caregivers, and professionals. This self-report questionnaire contains 30 true/false items. The total score is the sum of the scores from the 30 items, which is quantitative and ranges from 0-30, with a higher score indicating better knowledge about AD. To aide interpretation, change in ADKS scores were converted to standardized change scores by dividing the covariate-adjusted least squares mean change by the baseline standard deviation. The results reported are the standardized change on the scale from baseline to month 12. The converted to standardized score range is -10.81 to +10.81. The greater the positive change in score, the greater the increase in knowledge of dementia.

4 secondary outcomes

Change in Self-efficacy From Baseline to Month 12
Time frame: 12 months
To Evaluate Usability of BHPro
Time frame: 12 months
Number of Chapters Completed on BHPro
Time frame: 12 months
To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ).
Time frame: 12 months

Results and safety

Results posted to the registry on 2 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BHSP-Main	354	315

Primary outcome: Change in Dementia Literacy From Baseline to Month 12

Time frame: 12 months. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	BHSP Main n = 353
Value	0.191 (-0.014 to 0.397)

Population analysed: Intention To Treat (ITT) sample: Includes all participants who (1) meet screening criteria (2) and completed at least 1 assessment at baseline. Covariates include: age, sex, race, cognitive status, and Heaton education score.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data is collected from Baseline up to 30 days after study participation has ended. This is approximately 1 year for participants who remained in the study until the end and less time for those who withdrew early. Systematic collection of AEs occurred at the following study visits: Baseline, Month 6, Month 12. Non-systematic AE reporting, spontaneous reporting by participant, was also implemented.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BHSP Main	0 of 353 (0%)	3 of 353 (0.8%)	0 of 353

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40090784Belleville 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.
Derived from this study: PubMed 37874110Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, Durant J, Lupo JL, Revta C, Chan S, Cuesta M, Slack PJ, Winer S, Brewster PWH, Hofer SM, Lim A, Centen A, Jacobs DM, Anderson ND, Walker JD, Speechley MR, Zou GY, Chertkow H. Protocol for the Brain Health Support Program Study of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP): A Prospective 12-Month Intervention Study. J Prev Alzheimers Dis. 2023;10(4):875-885. doi: 10.14283/jpad.2023.65.

Related trials for Dementia Prevention

Not yet recruitingPhase 2
AV-1959R Vaccine in Individuals With Preclinical Alzheimer's Disease
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Recruiting
Dementia and Diabetes Prevention Program
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Recruiting
Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
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Not yet recruiting
High-Velocity Resistance Training for Brain Blood Flow and Cognitive Function in Older Adults
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Active, not recruitingPhase 4
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brain Health PRO in people with Dementia Prevention and Mild Cognitive Impairment, run by Baycrest at 7 sites 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 15 inclusion and 7 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dementia Literacy From Baseline to Month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05347966, which also lists 2 linked publications.

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 2 May 2025.