Risk BehaviorPhase 3NCT06748625
Efficacy of a Multidomain Intervention on Lifestyle Risk Factors for Dementia Prevention
A Phase 3 study testing Luci Coach-Assisted Intervention in people with Risk Behavior and Cognitive Decline, run by LuciLab at 1 site in Canada.
Trial summary
Alzheimer's Disease (AD) and other Dementias have far-reaching consequences on the lives of sufferers and their loved ones, not to mention the impact on the healthcare system. Several studies have identified protective lifestyle habits that might help reduce the risk of cognitive decline: cognitive engagement… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Cognitive Decline
- What is being tested?
- Luci Coach-Assisted Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteCanada
- Study dates
- 13 Mar 2025to 11 Oct 2026
- Phase
- Phase 3
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 50 and 75;
- Proficient or native speakers in French or English;
- Computer literate defined as being able to read mails and browse the Internet, and having access to a computer or tablet with an Internet connection;
- Eligible in at least one of the 3 intervention domains, where eligibility is defined as follows:
- Low cognitive engagement in cognitively stimulating activities, defined as a score ≤ 22 on the adapted Cognitive Activity Questionnaire;
- Low level of physical activity defined as less than 150 minutes/week) of moderate to vigorous physical activity measured using the Godin- Shephard Leisure Time Physical Activity Questionnaire, and no medical contraindication to physical activity based on the Physical Readiness Questionnaire for Everyone (PAR-Q+);
- Low adherence to the Mediterranean-type diet defined as a score of ≤ 8 on the adapted Canadian Mediterranean Diet Scale, and no dietary restriction, severe allergy or intolerance or history of eating disorder.
Who cannot join
- Presence of a cognitive impairment as measured by the Creyos Dementia Assessment;
- General anesthesia within the last 6 months;
- Previous participation in the Luci program or in any validation studies related to the program;
- Current participation in another study;
- Unable to commit participation over the period of the study;
- Being in the precontemplation stage of change;
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- High level of perceived stress;
- Having received a diagnosis of :
- Dementia or neurodegenerative disease (AD and other dementias);
- Past or present neurological disorder (multiple sclerosis, brain tumour, epilepsy, stroke, traumatic brain injury);
- Severe psychiatric disorder (schizophrenia, major depression, bipolar disorder);
- Diabetes or hypertension without medical monitoring;
- Alcoholism or drug addiction;
- Any other condition expected to limit participation (e.g., low visual acuity).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored, Multidomain, and Coach-assisted Digital Program for the Adoption and Maintenance of a Healthy Lifestyle in Middle-aged and Older Adults With Modifiable Risk Factors for Dementia: An Efficacy Study
Alzheimer's Disease (AD) and other Dementias have far-reaching consequences on the lives of sufferers and their loved ones, not to mention the impact on the healthcare system. Several studies have identified protective lifestyle habits that might help reduce the risk of cognitive decline: cognitive engagement, physical activity, and a healthy diet. Our aim is to determine the efficacy of the Luci program, an online, coach-assisted, multidomain, behavioural intervention designed to help middle-aged to older adults reduce their risk of dementia by improving their lifestyle habits. In this study, we hope to demonstrate that participating in the Luci program helps to improve lifestyle habits and that the program could therefore become an effective health promotion tool.
Read the detailed description
Multidomain lifestyle interventions supported by technology might help dementia prevention by reducing the risk associated with lifestyle behaviours. The goal of Luci is to help middle-aged to older adults improve modifiable lifestyle risk factors (diet, physical activity and cognitive engagement) associated with cognitive decline. The intervention is a theory-based, tailored, multidomain, coach-assisted program offered through an interactive online platform promoting healthy lifestyle behaviour changes and their maintenance.
The project deployment follows the Obesity-Related Behavioural Intervention Trials (ORBIT) model. A proof-of-concept study (NCT04616794) was conducted followed by a feasibility study (NCT05141578). All targets (recruitment, enrolment, retention, acceptability, and adherence) were met, which suggests that the protocol is feasible and acceptable and supports moving forward to the efficacy trial.
This study is a 2-arm, randomized, single-blind, parallel-group study aiming to assess the immediate post-intervention (24-weeks) effects of the Luci intervention and their 52-week maintenance, compared to a Waitlist condition in at-risk middle-aged to older individuals. Assessments will be done at Screening (T0), Baseline (T1), week 12 (T2), week 24 (T3), and week 52 (T4).
The primary objective of this study is to determine whether the Luci intervention can result in a greater number of people reducing their behavioural risks when compared to the Waitlist condition. It is hypothesised that the proportion of people with a significant risk reduction will be higher in the Luci condition than in the Waitlist condition.
Individuals assigned to the Intervention group have weekly (weeks 1-12) or bi-monthly (weeks 13-24) sessions with their coach. Coaching sessions last 30 or 60 minutes and are conducted by video call and/or through a chat system.
Throughout the coaching sessions, participants are assisted in creating personalised behavioural SMART (specific, measurable, attainable, relevant and time bound) goals. Coaches also provide motivational support as well as tools to help participants maintain their behaviour changes.
- Conditions
- Risk Behavior, Cognitive Decline
- Being tested
- Luci Coach-Assisted Intervention
- Keywords
- Primary Prevention, Aging, Cognition
- Medical subject headings
- Risk-Taking, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luci Coach-Assisted InterventionBehavioural
The Luci intervention is a personalized behaviour change program delivered via an interactive web platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement. Participants will be encouraged to adopt a healthy lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and by assisting participants outlining SMART goals to progressively adopt and maintain a healthier lifestyle. Coaching sessions will be held on a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24.
| Study group | Role | What they receive |
|---|---|---|
| Luci intervention | Experimental | Participants enrolled in this group will receive the Luci intervention for a 24-week period. Receives: Behavioral: Luci Coach-Assisted Intervention |
| Wait-list Control | No intervention | Participants in the waiting-list control group will not receive any intervention during the study. They will be invited to participate in the program at the end of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle Risk Reduction criterion
The primary endpoint is the number of participants showing a clinically significant change (CSC) from Screening to Week 24 in at least one eligible domain (cognitive engagement, physical activity, mediterranean diet adherence).
Measured: Change from Screening to Week 24
Cognitive Engagement
Cognitive engagement is measured using the Vemuri Cognitive Activity Questionnaire. Participants are asked to indicate the frequency in which they engage in 10 types of cognitive leisure activities. Scores range from 0 to 70. A higher score represents a higher cognitive engagement level. A clinically significant change is defined as a 6-point minimum increase.
Measured: Screening, Week 12, Week 24, Week 52
Physical Activity
Physical activity is measured using the modified Godin-Shephard Leisure Time Physical Activity Questionnaire which consists of three sets of questions (6 items). An overall physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, as well as a moderate-to-vigorous physical activity (MVPA) score. A higher MET value represents a higher physical activity level. A clinically significant change is defined as a 300 MET-min/week minimum increase in the MVPA score.
Measured: Screening, Week 12, Week 24, Week 52
Mediterranean Diet Adherence
Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale. The scale consists of 13 questions on food consumption frequency and intake habits. Scores range from 0 to 13, where a higher score represents a higher adherence level. A clinically significant change is defined as a 2-point minimum increase.
Measured: Screening, Week 12, Week 24, Week 52
Secondary outcomes (2)
Quality of Life
Quality of life is measured with the SF-12v2, a 12-item questionnaire.
Measured: Baseline, Week 24, Week 52
Cognitive Performance
Cognitive Performance is assessed using the Creyos Dementia Assessment, a computer-administered cognitive test battery that includes 6 tasks measuring 3 cognitive domains (memory, reasoning and verbal abilities). Several scores are calculated: one for each of the 6 individual tests, one for each of the 3 cognitive domains, as well as an overall score. Higher scores indicate higher cognitive performance.
Measured: Screening, Week 24, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start13 Mar 2025
- Primary completion23 Mar 2026
- Study completion11 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- LuciLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748625
- Sponsor's protocol ID
- LUCI-03
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored, Multidomain, and Coach-assisted Digital Program for the Adoption and Maintenance of a Healthy Lifestyle in Middle-aged and Older Adults With Modifiable Risk Factors for Dementia: An Efficacy Study
- ClinicalTrials.gov ID
- NCT06748625
- Acronym / sponsor ID
- LUCI-03
- Conditions
- Risk Behavior, Cognitive Decline
- Keywords
- Primary Prevention, Aging, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- LuciLabIndustry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Sojecci II Ltd
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 11 Oct 2026 (actual)
- First posted
- 27 Dec 2024 (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.
Alzheimer's Disease (AD) and other Dementias have far-reaching consequences on the lives of sufferers and their loved ones, not to mention the impact on the healthcare system. Several studies have identified protective lifestyle habits that might help reduce the risk of cognitive decline: cognitive engagement, physical activity, and a healthy diet. Our aim is to determine the efficacy of the Luci program, an online, coach-assisted, multidomain, behavioural intervention designed to help middle-aged to older adults reduce their risk of dementia by improving their lifestyle habits. In this study, we hope to demonstrate that participating in the Luci program helps to improve lifestyle habits and that the program could therefore become an effective health promotion tool.
Detailed description
Multidomain lifestyle interventions supported by technology might help dementia prevention by reducing the risk associated with lifestyle behaviours. The goal of Luci is to help middle-aged to older adults improve modifiable lifestyle risk factors (diet, physical activity and cognitive engagement) associated with cognitive decline. The intervention is a theory-based, tailored, multidomain, coach-assisted program offered through an interactive online platform promoting healthy lifestyle behaviour changes and their maintenance.
The project deployment follows the Obesity-Related Behavioural Intervention Trials (ORBIT) model. A proof-of-concept study (NCT04616794) was conducted followed by a feasibility study (NCT05141578). All targets (recruitment, enrolment, retention, acceptability, and adherence) were met, which suggests that the protocol is feasible and acceptable and supports moving forward to the efficacy trial.
This study is a 2-arm, randomized, single-blind, parallel-group study aiming to assess the immediate post-intervention (24-weeks) effects of the Luci intervention and their 52-week maintenance, compared to a Waitlist condition in at-risk middle-aged to older individuals. Assessments will be done at Screening (T0), Baseline (T1), week 12 (T2), week 24 (T3), and week 52 (T4).
The primary objective of this study is to determine whether the Luci intervention can result in a greater number of people reducing their behavioural risks when compared to the Waitlist condition. It is hypothesised that the proportion of people with a significant risk reduction will be higher in the Luci condition than in the Waitlist condition.
Individuals assigned to the Intervention group have weekly (weeks 1-12) or bi-monthly (weeks 13-24) sessions with their coach. Coaching sessions last 30 or 60 minutes and are conducted by video call and/or through a chat system.
Throughout the coaching sessions, participants are assisted in creating personalised behavioural SMART (specific, measurable, attainable, relevant and time bound) goals. Coaches also provide motivational support as well as tools to help participants maintain their behaviour changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luci intervention | Experimental | Behavioral: Luci Coach-Assisted InterventionParticipants enrolled in this group will receive the Luci intervention for a 24-week period. |
| Wait-list Control | No intervention | –Participants in the waiting-list control group will not receive any intervention during the study. They will be invited to participate in the program at the end of the trial. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 50 and 75;
- Proficient or native speakers in French or English;
- Computer literate defined as being able to read mails and browse the Internet, and having access to a computer or tablet with an Internet connection;
- Eligible in at least one of the 3 intervention domains, where eligibility is defined as follows:
Key exclusion criteria (14 listed)
- Presence of a cognitive impairment as measured by the Creyos Dementia Assessment;
- General anesthesia within the last 6 months;
- Previous participation in the Luci program or in any validation studies related to the program;
- Current participation in another study;
- Unable to commit participation over the period of the study;
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 |
|---|---|---|
| Luci Coach-Assisted InterventionThe Luci intervention is a personalized behaviour change program delivered via an interactive web platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement. Participants will be encouraged to adopt a healthy lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and by assisting participants outlining SMART goals to progressively adopt and maintain a healthier lifestyle. Coaching sessions will be held on a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24. | Behavioural | Luci intervention |
Primary outcome
Lifestyle Risk Reduction criterion
Time frame: Change from Screening to Week 24
The primary endpoint is the number of participants showing a clinically significant change (CSC) from Screening to Week 24 in at least one eligible domain (cognitive engagement, physical activity, mediterranean diet adherence).
Cognitive Engagement
Time frame: Screening, Week 12, Week 24, Week 52
Cognitive engagement is measured using the Vemuri Cognitive Activity Questionnaire. Participants are asked to indicate the frequency in which they engage in 10 types of cognitive leisure activities. Scores range from 0 to 70. A higher score represents a higher cognitive engagement level. A clinically significant change is defined as a 6-point minimum increase.
Physical Activity
Time frame: Screening, Week 12, Week 24, Week 52
Physical activity is measured using the modified Godin-Shephard Leisure Time Physical Activity Questionnaire which consists of three sets of questions (6 items). An overall physical activity score is computed in Metabolic equivalent tasks (MET)-minutes/week, as well as a moderate-to-vigorous physical activity (MVPA) score. A higher MET value represents a higher physical activity level. A clinically significant change is defined as a 300 MET-min/week minimum increase in the MVPA score.
Mediterranean Diet Adherence
Time frame: Screening, Week 12, Week 24, Week 52
Adherence to the Mediterranean Diet is measured with an adaptation of the Canadian Mediterranean Diet Scale. The scale consists of 13 questions on food consumption frequency and intake habits. Scores range from 0 to 13, where a higher score represents a higher adherence level. A clinically significant change is defined as a 2-point minimum increase.
2 secondary outcomes
Quality of Life
Time frame: Baseline, Week 24, Week 52
Cognitive Performance
Time frame: Screening, Week 24, Week 52
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Luci Coach-Assisted Intervention in people with Risk Behavior and Cognitive Decline, run by LuciLab at 1 site 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 7 inclusion and 14 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 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lifestyle Risk Reduction criterion (time frame: Change from Screening to Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.