A Phase 3 interventional study of Luci Coach-Assisted Intervention in Risk Behavior and Cognitive Decline, sponsored by LuciLab. Completed at 1 site in Canada. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by LuciLab · Phase 3, Interventional, and Prevention
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.
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.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 368 is above the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →LuciLab is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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.
Eligible in at least one of the 3 intervention domains, where eligibility is defined as follows:
Exclusion Criteria :
Having received a diagnosis of :
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants enrolled in this group will receive the Luci intervention for a 24-week period.
Behavioral: Luci Coach-Assisted 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.
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening, Week 12, Week 24, Week 52
Quality of Life
Quality of life is measured with the SF-12v2, a 12-item questionnaire.
Time frame: 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.
Time frame: Screening, Week 24, Week 52
Multifactorial index of dementia risk
The CAIDE (Cardiovascular risk factors, aging, and incidence of dementia) is a multifactorial risk estimation scale using age, hypertension, hypercholesterolemia, physical activity level, obesity (BMI), and educational level. A higher score indicates a higher risk of dementia.
Time frame: Baseline, Week 24, Week 52
Perceived Stress
Perceived stress is investigated using a single question answered on a 5-item Likert scale where a higher score indicates a higher stress level.
Time frame: Screening, Week 24, Week 52
Sleep Quality
Sleep quality is assessed using a single question taken from the Pittsburgh Sleep Quality Index. The score is derived from a 4-point Likert scale where a higher score indicates worse sleep quality.
Time frame: Baseline, Week 24, Week 52
Anxiety Symptoms
Anxiety symptoms over the past 2 weeks are assessed using the Generalized Anxiety Disorder (GAD-7) Scale which comprises 7 items which are scored "0" (Not at all) to "3" (Nearly every day) for a maximum total score of 21. A higher score indicates higher anxiety symptoms.
Time frame: Baseline, Week 24, Week 52
Curent Memory Concerns
Current memory concerns are evaluated with a single 3-item question.
Time frame: Baseline, Week 24, Week 52
Readiness to Change
Readiness to change is assessed for each of the 3 intervention domains using a question with five answer options.
Time frame: Baseline, Week 12, Week 24, Week 52
Self-efficacy
Self-efficacy is evaluated with the General Self-Efficacy (GSE) Scale which consists of 10 items which are scored from "1" (Not True At All) to "4" (Exactly True) for a maximum score of 40. A higher score indicates greater self-efficacy.
Time frame: Baseline, Week 12, Week 24, Week 52
Motivations
Motivations are assessed via the Treatment Self-Regulation Questionnaire (TSRQ), which assesses different forms of motivation. It consists of 15 items, each rated on a 7-point scale ranging from 1 (not at all true) to 7 (very true). The items are combined into 4 subscales, for which 4 subscores can be calculated. Each subscore ranges from 1 to 7, with a higher subscore indicating higher importance of that form of motivation.
Time frame: Baseline, Week 12, Week 24, Week 52
Dementia Literacy
Dementia literacy is assessed using 20 questions answered using 5-point Likert scales for a maximum score of 100. A higher score indicates better dementia literacy.
Time frame: Baseline, Week 12, Week 24, Week 52
Perceived Progress
Perceived progress will be measured with one question rated on a 5-point Likert scale for each intervention domain.
Time frame: Week 12, Week 24, Week 52
Luci Cognitive Engagement Score
In the Luci Cognitive Engagement Questionnaire, 14 types of cognitively stimulating leisure activities are provided, and participants are asked to indicate the frequency in which they engage in those activities. Each question is rated from 0 (Never) to 7 (Every day), for a maximum total score of 98. A higher score represents a higher cognitive engagement level.
Time frame: Baseline, Week 12, Week 24, Week 52
Luci Physical Activity Score
In the Luci Physical Activity Questionnaire, participants choose which activities they engage in from a list of almost 70 physical activities. For the selected activities, they are asked to indicate frequency, duration and intensity. Responses are used to calculate the Luci Physical Activity score as well as 3 subscores related to aerobic exercise, muscular resistance, and flexibility training, respectively. A higher score represents a higher physical activity level.
Time frame: Baseline, Week 12, Week 24, Week 52
Luci Medi Diet Adherence Score
The Luci Medi Diet Adherence Questionnaire consists of 15 questions on consumption frequency for 13 food groups that are considered characteristic of the Mediterranean diet. A subscore ranging from 0 to 3 is assigned to each food group. Total scores range from 0 to 39, where a higher score represents a higher adherence level.
Time frame: Baseline, Week 12, Week 24, Week 52
Health Service Utilisation
Health care utilisation is assessed using a questionnaire that collects self-reported number of visits to physicians, mental health providers, other providers, emergency department as well as hospital stays, nights in hospital and outpatient surgeries. Total score is the sum of all visits, hospital stays and nights.
Time frame: Baseline, Week 24, Week 52
Retention Rate
Retention rate is the proportion of randomized participants completing at least one of the measures at T3 and T4
Time frame: Week 24, Week 52
Program Adherence
Program adherence is defined as the proportion of participants from the Luci condition who adhered to the program. Participants are considered adherent if they complete at least 12 of the 18 coaching sessions.
Time frame: Week 24
Platform Usage
Pattern of use, frequency, duration of use and functionalities used are continuously monitored throughout the program and the data will be analysed.
Time frame: Week 24
User Experience
User experience is assessed in participants randomized to the Luci intervention using 36 questions of which 29 are rated on a 5-point Likert scale, 3 are rated on categorical scales, and 4 are free text.
Time frame: Week 24
Usability
Usability is assessed using the System Usability Scale (SUS) a five-item questionnaire rated with a 5-point Likert scale.
Time frame: Week 24
Goal Attainment
Goal attainment and perceived effort to reach the goal are rated by participants in the Luci intervention arm before each coaching sessions. These are reported using 3-point scales.
Time frame: Weekly up to Week 12, then bi-weekly up to Week 24
Plan to share: No
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Ran from Mar 2025 to primary completion in Mar 2026, 12 months.
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