An interventional study of Brain Health PRO (BHPRO) in Dementia, Alzheimer's Disease and Health Behavior, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Recruiting at 1 site in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Not applicable, Interventional, and Health services research
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Among 321 studies in Alzheimer Disease with a site in Canada — 60 open to participants now, 81 under way, 23 of them phase 3. Alzheimer Disease · Canada.
Among the 321 studies in Alzheimer Disease with a site in Canada, this one is the 92nd largest by planned enrollment of the 281 interventional ones that give a count, is one of 15 that started in 2026, is one of 68 with no phase, reaches primary completion later than 45 of the 80 other live ones, and was the 315th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →60 of the 321 studies in Alzheimer Disease with a site in Canada are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Canada, United States, Argentina and 7 more countries
Ages 55–80
Eisai Limited · Sites in Canada
Sanofi · Sites in Canada, United States, Australia and 4 more countries
Ages 55–85
McMaster University · Sites in Canada
Ages 55+
McGill University · Sites in Canada
Ages 18+ · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 50 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
321 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 99 · Phase 3 117 · Phase 4 4
First in 1999; this study’s year is marked. 15 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 434 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 241 across the 281 interventional studies, 500 across the 39 observational. Of the 224 that completed or were terminated, 104 (46%) have results posted.
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196 of 321 have an industry lead sponsor. The 10 most frequent:
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal has 1 study filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
18 of the studies in Alzheimer Disease with a site in Canada that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT06529744University Health Network, TorontoImproving Prognostic Confidence in Neurodegenerative Diseases Causing Dementia Using Peripheral Biomarkers and Integrative Modeling | 2026-11 |
Add all 18 to your calendar (.ics) → With an account.
Among the 321 studies in Alzheimer Disease with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Brain Health PRO (BHPRO) is a 6-month, web-based dementia-risk-reduction program targeting modifiable risk factors for cognitive decline. This 12-months, multi-site, single-arm, mixed-methods implementation study (Hybrid Type III design) evaluates the real-world adoption, sustainability, and reach of BHPRO across 10-14 partner sites in Canada, spanning seven provinces, including community organizations, clinics, and a public-health agency, with emphasis on rural and underserved communities. Tailored implementation toolkits (BHPRO-ITs), co-developed during Phase 1 using the ERIC taxonomy, are deployed at each site. Implementation outcomes (adoption, sustainability, reach, appropriateness, feasibility) are assessed at provider and organizational levels via online questionnaires and twice-monthly champion meetings. Effectiveness outcomes (dementia literacy, self-efficacy, modifiable risk factor composite, cognition) are collected from end users (adults aged 50+, at risk of dementia) at baseline, 3 months, post-program (6 months), and follow-up (12 months).
Introduction: Dementia represents a major and growing challenge for public health. Approximately 45% of dementia cases worldwide, and up to 49% in Canada, are attributable to modifiable risk factors. Multidomain prevention trials have demonstrated that targeting these risk factors can improve cognitive outcomes among at-risk individuals. However, such interventions are typically resource-intensive, rely on face-to-face supervision, and are difficult to scale across diverse and geographically dispersed populations. Brain Health PRO (BHPRO) is a six-month, web-based dementia risk reduction program co-developed with researchers and older adults across Canada. A prior multi-site efficacy trial involving 350 participants demonstrated significant improvements in dementia literacy, self-efficacy, and modifiable risk factors under controlled conditions. Despite demonstrated efficacy, successful translation into real-world settings requires systematic implementation strategies tailored to organizational context. This study evaluates real-world implementation of BHPRO across diverse Canadian community, clinical, and public health settings, with particular emphasis on rural and underserved populations. Phase 1 of this study (January 2025-2026) established formal partnerships with fourteen sites across seven Canadian provinces, conducted needs assessments, identified barriers and facilitators to implementation, and co-developed tailored, site-specific implementation strategies through collaborative planning with organizational stakeholders.
Objectives: The primary objective of this study is to evaluate implementation success of BHPRO across ten to fourteen Canadian sites by assessing adoption, implementation sustainability, and reach. Secondary implementation objectives include assessing perceived appropriateness and feasibility of the program and identifying contextual determinants that influence implementation success across settings. In parallel, effectiveness objectives at the end-user level include evaluating changes in dementia literacy, self-efficacy, composite modifiable dementia risk, individual modifiable risk domain scores, and cognitive performance, as well as assessing adherence, usability, and program acceptance.
Hypothesis: The central hypothesis is that BHPRO can be feasibly, appropriately, and sustainably implemented across diverse delivery channels in Canada through tailored, context-specific implementation strategies developed during Phase 1. It is hypothesized that at least 70% of eligible sites will adopt BHPRO within three months of rollout, at least 64% of adopting sites will sustain implementation at twelve months, and at least 67% of interested end users will enroll and initiate the program. It is further hypothesized that participating end users will demonstrate within-person improvements over time in dementia literacy, self-efficacy, composite modifiable risk profile, and cognitive performance. These benchmarks are derived from meta-analytic estimates in the implementation science literature and were used as the basis for formal power calculations.
Design: This study is a twelve-month, mixed-methods, multi-centre Hybrid Type III effectiveness-implementation study employing a single-arm design. Ten to fourteen Canadian sites, including community organizations, clinical settings, and public health agencies, will implement BHPRO using site-specific implementation toolkits co-developed during Phase 1, based on strategies identified using the Expert Recommendations for Implementing Change (ERIC) taxonomy and tailored to each site's context following Phase 1 needs assessments and barriers and facilitators analyses. Sites may adapt implementation approaches; these adaptations will be documented using the Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME). The rollout will be staggered over a three to four month period to ensure adequate research team support. Implementation outcomes are prioritized and will be measured at the site level at three, six, and twelve months using structured quantitative tools and qualitative methods including focus groups and interviews. Effectiveness outcomes will be measured at the individual participant level at baseline, mid-way, immediately post-intervention at six months, and at six-month follow-up (twelve months). The study does not involve randomization or masking. Approximately 350 end users are expected to participate across sites. Data collection includes online questionnaires, platform-based analytics, structured documentation of implementation processes through twice-monthly online meetings with site champions and validated computerized cognitive assessments. The design integrates quantitative and qualitative data to evaluate both implementation processes and participant-level outcomes under real-world conditions.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
This study's planned enrollment of 434 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dementia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5.1. First-degree family history of dementia; 5.2. Formal education at or below 12 years; 5.3. Self-reported 5.3.1. Hypertension 5.3.2. Hypercholesterolemia 5.3.3. High (>30 kg/m2) 5.3.4. Physical inactivity (less than 20 to 30 minutes of physical activity, 2 times a week).
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participating sites implement BHPRO, a six-month, web-based dementia risk reduction program, using tailored implementation toolkits co-developed during Phase 1. Eligible end users at each site are offered access to the intervention. The study employs a single-group assignment without randomization or masking. Implementation is staggered across ten to fourteen Canadian sites, including community organizations, clinical settings, and one public health agency. The primary focus of the study is evaluation of implementation outcomes (adoption, sustainability, reach), while participant-level effectiveness outcomes are measured concurrently.
Behavioral: Brain Health PRO (BHPRO)
A 6-month, web-based dementia-risk-reduction program consisting of eight modules addressing modifiable risk factors: physical activity, diet, cognitive engagement, sleep, social and psychological health, vascular health, and vision/hearing health. Upon registration, participants complete baseline lifestyle questionnaires that generate a personalized risk profile. Participants are instructed to prioritize three risk domains based on their profile and receive tailored content accordingly. Materials include narrated educational content, visual aids, quizzes, interactive exercises, and evidence-based recommendations. Content is delivered gradually (four 10-minute chapters per week). All modules remain accessible throughout participation. Program engagement metrics, including chapter completion, are automatically captured through the platform.
Implementation outcome = Adoption
The delivery of the intervention by the sites. Measure: Site implementation logs and twice-monthly champion reports; quantitative questionnaires Benchmark: ≥70% of sites adopt within 3 months of rollout.
Time frame: 3 months after rollout initiation at each site
Implementation outcome = Sustainability
The extent to which the intervention continues to be delivered by the sites one year after starting implementation. Measure: Site implementation logs; program delivery logs; site documentation; focus groups. Benchmark: ≥64% of adopting sites.
Time frame: 12 months after rollout initiation at each site
Implementation outcome = Reach
Participants from the sites who start the program. Benchmark: ≥67%. BHPRO platform analytics (automated backend); Reach Reporter (site champions, every 6 months).
Time frame: 6 months and 12 months after rollout
Implementation outcome = Barriers and Facilitators to Implementation (Qualitative)
Multi-level barriers and facilitators to BHPRO adoption and sustainability. Measurements: Semi-structured focus groups with site staff (60-90 min, audio-recorded, transcribed verbatim); monthly online meetings with site champions; analyzed using reflexive thematic analysis (inductive + deductive CFIR/RE-AIM framework). NVivo. \~20% double-coded.
Time frame: 3, 6, and 12 months post-rollout
Implementation outcome = Appropriateness
The perceived fit, relevance, and compatibility of Brain Health PRO and of the Brain Health PRO Implementation Toolkit for the setting, as perceived by providers and organizational staff. Measurements: Intervention Appropriateness Measure (IAM); a validated 4-item questionnaire. Each item is rated on a 5-point Likert scale. Item responses are averaged to produce the scale score. Unit of Measure: Mean Intervention Appropriateness Measure score (range 4-20; higher = greater perceived appropriateness).
Time frame: 6 months post-rollout
Implementation outcome = Feasibility
The extent to which Brain Health PRO can be successfully used or carried out within a given setting, as perceived by providers and organizational staff. Measurements: Feasibility of Intervention Measure (FIM); a validated 4-item questionnaire. Each item is rated on a 5-point Likert scale. Item responses are averaged to produce the scale score. Unit of Measure: Mean Feasibility of Intervention Measure score (range 4-20; higher = greater perceived feasibility).
Time frame: 3, 6, and 12 months post-rollout
Effectiveness outcome = Dementia Literacy
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. Measurements: This self-report questionnaire contains 30 true/false items. Unit of measure: 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.
Time frame: Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Self-Efficacy
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. Measurements: his self-report questionnaire contains 10-items, each rated on a 4-point scale (not true at all, hardly true, moderately true, exactly true). Unit of measure: Responses are provided on a Likert scale. 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
Time frame: Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Composite Modifiable Risk Factor Score
Change in composite score across 7 BHPRO dementia-risk domains: physical activity, nutrition, sleep, cognitive engagement, social and psychological health, vascular health, and vision and hearing. Details for each questionnaire are provided under separate outcomes. Measurements: Scores for each risk factor will be standardized (z-score transformation using cohort-wide mean and standard deviation at baseline). When necessary, scores will be multiplied by -1 so that positive scores reflect lower risk. The participant-level mean risk score will be calculated which reflects the average z-score for the participant across the modifiable risk factors.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Physical Activity
Description: The International Physical Activity Questionnaire-Short Form is a brief 7-item self-report measure that captures types of and intensity of physical activity and sitting time. Measurements: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0-9, with a higher score indicating more physical activity.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Nutrition
Description: Shorter 11-item version of the Eating Pattern Self-Assessment Questionnaire developed by CCNA Team 5. Measurement: The total score is calculated by calculating the accrued number of points assigned per question. The total score ranges between 0 and 22, with a higher score indicating more healthy eating habits.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Sleep
Description: Brief 10-item questionnaire developed by BHPro sleep module content leads that assesses sleep duration, sleep patterns, and difficulties and daytime fatigue over the past 3 months. Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 1 and 20, with a higher score indicating healthier sleep.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Cognitive Engagement
Description: A 6-item questionnaire assessing types and duration of cognitively engaging activities. Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between 0 and 36, with a higher score indicating more cognitively stimulating activities.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Social and Psychological Health
Description: An 8-item questionnaire comprising 1 item on loneliness, 1 item on ageism, 1 item on subjective age, 1 item on essentialist beliefs of aging and 4 items on depression, anxiety, stress, and social support from STOP-D. Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -1 and 50, with a higher score indicating poorer social and psychological health.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Vascular Health
Description: 12-item self-report questionnaire developed by the BHPro Vascular Health team based on the American Heart Association's Life's Simple Seven checklist of the main risk factors for heart disease and stroke. Measurement: The total score is calculated by summing the accrued number of points assigned per question. The total score ranges between -4 and 8, with a higher score indicating better vascular health.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Change in individual modifiable risk factors as measured separately by each of the 7 BHPro Lifestyle Risk Questionnaires: Vision and Hearing
Description: 10-item questionnaire developed by BHSP Vision and Hearing Module content leads that assesses perceived visual and auditory ability and actions taken to address potential vision/hearing difficulties. Measurement: The total score is calculated by summing the accrued number of points assigned per question. If a user selects "Yes" for example, they receive 2 points for that question. The total score ranges between 0 and 20 points, with a higher score indicating poorer vision and hearing.
Time frame: Baseline; mid-point (month 3); immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Cognition
Change in cognition as measured by the Cogniciti Brain Health Assessment after 6 months. Description: The Cogniciti Brain Health Assessment (BHA) is a self-administered validated computerized cognitive assessment comprised of four tests (Spatial Working Memory, Stroop Interference, Face-Name Association, and Number-Letter Alternation). Measurement: The overall Cogniciti Brain Health Assessment score ranges from 0-100 with a higher score indicating better cognition.
Time frame: Baseline; immediately post-program (month 6); 6-month follow-up (month 12)
Effectiveness outcome = Adherence
Proportion of BHPRO chapters completed. Target benchmark: ≥80% chapter completion. Measurements: BHPRO platform engagement log (number of chapters completed out of total available).
Time frame: Continuously tracked throughout the program duration (months 1-6); reported at post-program (month 6)
Effectiveness outcome = Usability
Usability of the Brain Health PRO platform, assessed with the System Usability Scale (SUS). Measurements: The SUS is a 10-item questionnaire; each item is rated on a 5-point Likert scale (from strongly disagree to strongly agree), worded in reference to Brain Health PRO. Item responses are transformed and summed to a raw score of 0-40, then multiplied by 2.5 to yield a total score ranging from 0 to 100. Benchmarks: scores above 68 indicate satisfactory usability; scores above 80 indicate excellent usability. Unit of Measure: Total SUS score (range 0-100; higher = better usability).
Time frame: Immediately post-program (month 6)
Effectiveness outcome = Technology acceptance
Acceptance of the Brain Health PRO (BHPRO) platform will be assessed using the Technology Acceptance Model Questionnaire (TAMQ). Measurements: The TAMQ is a 20-item questionnaire (adapted for BHPro) with 7-point scale. Unit of Measure: Responses are provided on a Likert scale. The total score ranges between 0-120, with a higher score indicating greater acceptance and satisfaction with BHPro.
Time frame: Immediately post-program (Month 6)
Plan to share: Yes — De-identified individual participant data underlying all published primary and secondary analyses, accompanied by a data dictionary and statistical analysis plan, will be made available upon reasonable request, subject to ethics committee review and approval and in accordance with the terms of participant informed consent. Qualitative data (focus group transcripts) will not be shared due to re-identification risk. Requests should be directed to the principal investigator at the coordinating site. Data will be retained on secure servers at the Centre de recherche de l'Institut Universitaire de Gériatrie de Montréal for at least 10 years from final enrollment.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Feb 2028, 20 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 20 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal