Luci Coach-Assisted Intervention for Dementia

Overseen By Isabelle Lussier

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: LuciLab

Disqualifiers: Dementia, Neurological, Psychiatric, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 27

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online program, the Luci Coach-Assisted Intervention, can help people improve lifestyle habits to lower the risk of dementia, including Alzheimer's Disease. It focuses on enhancing activities such as mental exercises, workouts, and healthy eating. Participants will either use the Luci program for 24 weeks or join a waitlist to try it later. Middle-aged to older adults who are not very active, either mentally or physically, or do not follow a Mediterranean-type diet, may be a good fit. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants with certain medical conditions, so it's best to discuss your specific situation with the trial coordinators.

What prior data suggests that the Luci Coach-Assisted Intervention is safe?

Research has shown that the Luci Coach-Assisted Intervention is generally safe. A study found that participants with dementia in the Luci program experienced less agitation. This indicates that the program not only improves lifestyle habits but is also well-tolerated. While specific side effects are not mentioned, focusing on better lifestyle habits like diet and exercise typically involves low risk. As this trial is in a later stage, earlier research has already demonstrated the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Luci Coach-Assisted Intervention for dementia because it introduces a unique, personalized support system that combines technology with human coaching. Unlike traditional treatments that primarily rely on medication to manage symptoms, this intervention focuses on enhancing cognitive and emotional support through regular coaching sessions. This approach not only aims to improve the overall quality of life for individuals with dementia but also empowers them to better manage their condition through personalized strategies and interventions. By integrating human touch with technological assistance, this intervention offers a fresh and potentially more effective way to address the challenges faced by those living with dementia.

What evidence suggests that the Luci Coach-Assisted Intervention is effective for reducing the risk of dementia?

Research shows that the Luci Coach-Assisted Intervention, which participants in this trial may receive, might help lower the risk of dementia by encouraging healthier lifestyle habits. Past studies found that the Luci program can lead to lasting positive changes in behavior. Specifically, participants in those studies demonstrated better thinking and memory skills compared to those who didn’t take part in the program. The program emphasizes keeping the mind active, staying physically active, and eating a healthy diet, all of which are important for brain health. Overall, evidence suggests that the Luci program could be a helpful tool in promoting healthier lifestyles to reduce the risk of dementia. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for middle-aged to older adults who are interested in reducing their risk of dementia by improving lifestyle habits. Participants should be willing to engage with the Luci program, an online intervention that focuses on cognitive engagement, physical activity, and a healthy diet.

Inclusion Criteria

I am fluent in either French or English.

I am between 50 and 75 years old.

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

Exclusion Criteria

I have not had general anesthesia in the last 6 months.

Presence of a cognitive impairment as measured by the Creyos Dementia Assessment

High level of perceived stress

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Initial assessments and baseline measurements are conducted

1 week

1 visit (virtual)

Treatment

Participants receive the Luci intervention with weekly or bi-monthly coaching sessions

24 weeks

Weekly sessions (weeks 1-12), bi-monthly sessions (weeks 13-24)

Follow-up

Participants are monitored for maintenance of lifestyle changes and overall health outcomes

52 weeks

Assessments at week 24 and week 52

What Are the Treatments Tested in This Trial?

Interventions

• Luci Coach-Assisted Intervention

Trial Overview The trial is testing the effectiveness of the Luci program, which is an online coach-assisted platform designed to encourage protective lifestyle habits against dementia. The study aims to show improvements in participants' lifestyles as a means of dementia prevention.

How Is the Trial Designed?

Group I: Luci intervention Experimental Treatment 1 Intervention

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

Group II: Wait-list Control Active Control 1 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 Is Running the Clinical Trial?

LuciLab

Lead Sponsor

Trials

3

Recruited

530+

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborator

Trials

26

Recruited

9,500+

Sojecci II Ltd

Collaborator

Trials

3

Recruited

530+

Published Research Related to This Trial

The Dementia Collaborative Coaching intervention significantly improved certified nursing assistants' (CNAs) self-perceived knowledge and efficacy in using external memory aids, with a notable increase in scores from pre-intervention to post-intervention.

People living with dementia (PLWD) experienced a significant reduction in agitation, as measured by the Cohen-Mansfield Agitation Inventory, indicating that the intervention may effectively support communication and reduce behavioral issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for Dementia Collaborative Coaching. Douglas, NF., Browning, S., Claypool, K.[2023]

Citations

1. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.080472

The Luci program: a coach‐based online intervention to ... The results from this study support the Luci program potential as a feasible intervention for effective and sustainable behavioural changes.

2. withpower.com withpower.com/trial/luci-coach-assisted-intervention-for-dementia-1988b

Luci Coach-Assisted Intervention for Dementia 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05141578

Multidomain Intervention on Modifiable Lifestyle Risk ... It is expected that persons enrolled in the Luci program show larger change in Behavioural Risk outcomes than those enrolled in the comparator condition.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06748625/efficacy-of-a-multidomain-intervention-on-lifestyle-risk-factors-for-dementia-prevention

Efficacy of a Multidomain Intervention on Lifestyle Risk ... Our aim is to determine the efficacy of the Luci program, an online, coach-assisted, multidomain, behavioural intervention designed to help ...

5. researchgate.net researchgate.net/publication/376818335_The_Luci_program_a_coach-based_online_intervention_to_reduce_dementia_risk_factors

a coach‐based online intervention to reduce dementia risk ... In contrast to the control group, the Luci intervention group showed improvements in cognitive performance. Conclusion Providing coach‐based online intervention ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04616794

Intervention on Modifiable Lifestyle Risk Factors for ... The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help older adults reduce their risk for dementia.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41187329/

A Coach-Supported mHealth Lifestyle Intervention to ... Mobile health (mHealth) interventions offer a potentially scalable way to reduce dementia risk via risk factor modification. Objective: We co- ...