Last reviewed · How we verify

NCT05347966: CTU: BHSP

Brain Health Support Program

Completed NA Results posted Last updated 2 May 2025
What this trial tests

NA trial testing Brain Health PRO in Dementia Prevention in 354 participants. Completed in 19 April 2024.

Timeline
6 April 2022
Primary endpoint
5 January 2024
19 April 2024

Quick facts

Lead sponsorBaycrest
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment354
Start date6 April 2022
Primary completion5 January 2024
Estimated completion19 April 2024
Sites7 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Baycrest — full company profile →

Who can join

Adults 60 to 85, any sex, with Dementia Prevention or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Dementia Literacy From Baseline to Month 12 Primary · 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

GroupValue95% CI
BHSP Main0.191-0.014 – 0.397
Change in Self-efficacy From Baseline to Month 12 Secondary · 12 months

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 s

GroupValue95% CI
BHSP Main0.1570.042 – 0.272
To Evaluate Usability of BHPro Secondary · 12 months

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.

GroupValue95% CI
BHSP Main34± 6
Number of Chapters Completed on BHPro Secondary · 12 months

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, wi

GroupValue95% CI
BHSP Main142± 60
To Evaluate User Acceptance of BHPro With the Technology Acceptance Model Questionnaire (TAMQ). Secondary · 12 months

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.

GroupValue95% CI
BHSP Main94± 18

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BHSP Main
Serious: 0/353 (0%)
Deaths: 0/353
Other adverse events (2 terms — click to expand)

ReactionSystemBHSP Main
Skin Reaction likely related to EEG headbandSkin and subcutaneous tissue disorders
Headache likely related to EEG headbandGeneral disorders

Data from ClinicalTrials.gov NCT05347966 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Feldman HH, Belleville S, Nygaard HB, Montero-Odasso M, et al · · 2023 · cited 26× · PMID 37874110 · DOI 10.14283/jpad.2023.65
  2. Brain health PRO/Santé cerveau PRO: The development of a web-based program for dementia literacy and risk factor reduction.
    Belleville S, Anderson ND, Bherer L, Camicioli R, et al · · 2025 · cited 2× · PMID 40090784 · DOI 10.1016/j.tjpad.2025.100134
  3. Comparing Traditional and Digital Cognitive Assessments in an Online Dementia Risk Reduction Program: Results from the CAN‐THUMBS‐UP Brain Health Support Program
    Brewster P, Jacobs D, Anderson N, Best J, et al · · 2025

Verify or expand the search:

Other trials of Brain Health PRO

Trials testing the same drug.

Other recruiting trials for Dementia Prevention

Currently open trials in the same condition.

Other Baycrest trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05347966.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing