DementiaCTU BHSP-PNCT05167045
A Pilot Study for the Brain Health Support Program
An observational study of Dementia and Mild Cognitive Impairment, run by Baycrest at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment
- What is being tested?
- Brain Health PRO
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Nov 2021to 29 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will recruit it's cohort from various locations around Canada.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of New Brunswick
Fredericton, New Brunswick, E3B 5A3
Baycrest
Toronto, Ontario, M6A 2E1
University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia
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.
- Conditions
- Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment, Pre-dementia, Dementia Prevention
- Being tested
- Brain Health PRO
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health PROBehavioural
Also called Brain Health Support Program
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.
| Study group | Role | What they receive |
|---|---|---|
| No Dementia | Not described Receives: Behavioral: Brain Health PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality of the BHSP
Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions
Measured: Nov 2021-Mar 2022
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
Measured: Nov 2021-Mar 2022
Usability of the BHSP
User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)
Measured: Nov 2021-Mar 2022
To assess participant satisfaction with the organization, presentation and personalization of the BHSP content
Qualitative evaluation of participant responses during the focus group discussion
Measured: Nov 2021-Mar 2022
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)
Measured: Nov 2021-Mar 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start15 Nov 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Chertkow, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167045
- Sponsor's protocol ID
- CTU BHSP-P
- Acronym
- CTU BHSP-P
- Status last verified
- Dec 2025
- First submitted
- 1 Nov 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 41278371Belleville 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Brain Health Support Program (BHSP) Intervention of the Canadian Therapeutic Platform Trial for Multidomain Interventions to Prevent Dementia
- ClinicalTrials.gov ID
- NCT05167045
- Acronym / sponsor ID
- CTU BHSP-P / CTU BHSP-P
- Conditions
- Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment, Pre-dementia, Dementia Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 22 Dec 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Dementia | – | Behavioral: Brain Health PRO |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit it's cohort from various locations around Canada.
Key inclusion criteria (8 listed)
- 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))
Key exclusion criteria (0 listed)
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: Brain Health Support ProgramThe 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. | Behavioural | No Dementia |
Primary outcome
Functionality of the BHSP
Time frame: Nov 2021-Mar 2022
Functionality of the web-based components of the BHSP measured in the pilot and qualitative focus group(s) questions
User acceptance of the BHSP
Time frame: Nov 2021-Mar 2022
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
Usability of the BHSP
Time frame: Nov 2021-Mar 2022
User satisfaction and evaluation of usability and acceptability of BHSP measured during the pilot and focus group(s)
To assess participant satisfaction with the organization, presentation and personalization of the BHSP content
Time frame: Nov 2021-Mar 2022
Qualitative evaluation of participant responses during the focus group discussion
To evaluate the feasibility of remote data collection
Time frame: Nov 2021-Mar 2022
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Results publication: PubMed 41278371Philip 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.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Mild Cognitive Impairment, run by Baycrest at 3 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 8 inclusion and 0 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functionality of the BHSP (time frame: Nov 2021-Mar 2022). The study lists 5 primary outcomes in all. 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 NCT05167045, 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 16 Jan 2026.