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

370 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Luci Coach-Assisted Intervention treatment for dementia?

The Luci Coach-Assisted Intervention for dementia may be supported by similar approaches like the Dementia Collaborative Coaching, which showed preliminary evidence of being acceptable and feasible for improving communication in dementia care. Additionally, interventions like the Personalized Approach and Targeted Interventions (PROACTIVE) Treatment Approach have shown improvements in managing dementia-related behaviors, suggesting that coach-assisted interventions could be beneficial. ^{1 2 3 4 5}

How is the Luci Coach-Assisted Intervention treatment different from other dementia treatments?

The Luci Coach-Assisted Intervention is unique because it focuses on communication coaching, which helps improve interactions between people with dementia and their caregivers. This approach is different from traditional treatments that may focus more on medication or physical health, as it emphasizes enhancing communication skills and understanding, which can be crucial for managing dementia. ^{3 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of an Acute Care Multicomponent Intervention for Dementia-Related Behavioral Expressions. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Challenging behaviours in nursing home residents with dementia: a randomized controlled trial of multidisciplinary interventions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for Dementia Collaborative Coaching. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Process evaluation of the response of nursing homes to the implementation of the dementia-specific case conference concept WELCOME-IdA: A qualitative study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The modified Hospital Elder Life Program: adapting a complex intervention for feasibility and scalability in a surgical setting. [2022]

6. England pubmed.ncbi.nlm.nih.gov

New guide helps carers use art in dementia care. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The Assessment of Language and Communication in Dementia: A Synthesis of Evidence. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to implement nurse-led interventions in long-term dementia care: a qualitative interview study with Swiss nursing experts and managers. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Maintenance of health and relief for caregivers of elderly with dementia by using "initial case management": experiences from the Lighthouse Project on Dementia, Ulm, ULTDEM-study]. [2021]