Efficacy of a Multidomain Intervention on Lifestyle Risk Factors for Dementia Prevention

NCT06748625 | Active Not Recruiting Phase 3

• 1 other identifier: LUCI-03
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Risk Behavior; Cognitive Decline

Keywords

Primary Prevention; Aging; Cognition

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  Screening, Week 12, Week 24, Week 52

Secondary Outcomes (2)

• Quality of Life

  Baseline, Week 24, Week 52

• Cognitive Performance

  Screening, Week 24, Week 52

Other Outcomes (20)

• Multifactorial index of dementia risk

  Baseline, Week 24, Week 52

• Perceived Stress

  Screening, Week 24, Week 52

• Sleep Quality

  Baseline, Week 24, Week 52

Study Arms (2)

Luci intervention

EXPERIMENTAL

Participants enrolled in this group will receive the Luci intervention for a 24-week period.

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.

Interventions

Luci Coach-Assisted Intervention BEHAVIORAL

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.

Luci intervention

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• LuciLab: lead
• Sojecci II Ltd: collaborator
• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: collaborator

Study Sites (1)

Lucilab

Montreal, Quebec, H2T 1A8, Canada

Location

MeSH Terms

Conditions

Risk-Taking; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 27, 2024
• Study Start: March 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)