- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237009
Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders
Effects of Personalized Reminiscence Sessions Delivered by a Digital Conversational Agent to Patients With Neurocognitive Disorders
This study aims to observe the effects of daily personalized digital reminiscence sessions, conducted with the help of a digital conversational agent, and to determine whether these sessions lead to improvements in symptoms such as apathy and depression.
The researchers therefore seek to observe whether this daily use can improve certain aspects of well-being, such as motivation, mood, sleep quality, quality of life, and engagement with the tool.
The study also aims to assess whether simple reminders delivered via the application are sufficient to encourage regular use without external assistance.
Participants will:
- Use the reminiscence app for 25 days for 10-15 minutes.
- Have a primary caregiver help personalize the app by sharing family memories, other relatives may optionally contribute in a private group.
- Complete brief questionnaires at the start and during follow-up routine visits (for example, apathy and depression scales, sleep, and quality of life).
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Peter MARKUS
- Phone Number: +36303621811
- Email: peter@kompanioncare.com
Study Locations
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Angers, France, 49 933
- Recruiting
- CHU Angers, Service médecine gériatrique.
-
Contact:
- Pr Cédric Annweiler
- Phone Number: (+33) 241 35 54 86
- Email: CeAnnweiler@chu-angers.fr
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Principal Investigator:
- Cédric Annweiler, Geriatrician, PhD neuroscience
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Limoges, France, 87042
- Recruiting
- Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department
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Contact:
- Pr Achille Tchalla
- Phone Number: +33 (0)5 55 05 88 94
- Email: Achille.Tchalla@chu-limoges.fr
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Principal Investigator:
- Achille Tchalla, PhD in medicine and CR
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Nice, France, 06100
- Recruiting
- Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Ressources et de Recherches (CM2R)
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Contact:
- Dr Aurelie Mouton
- Phone Number: +33 (0)4 92 03 47 70
- Email: mouton.a@chu-nice.fr
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Principal Investigator:
- Aurelie Mouton, Neurologist
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Paris, France, 75013
- Not yet recruiting
- APHP Hôpitaux universitaires Paris centre.
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Contact:
- Pr Olivier Hanon
- Phone Number: +33 (0) 1 44 08 33 81
- Email: olivier.hanon@aphp.fr
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Principal Investigator:
- Olivier Hanon, Professor of Geriatrics
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Tours, France, 37044
- Recruiting
- CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau.
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Contact:
- Pr Bertrand Fougère
- Phone Number: +33 (0)2 47473713
- Email: bertrand.fougere@univ-tours.fr
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Principal Investigator:
- Bertrand Fougère, Medical Doctor in Geriatrics
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants will be recruited during routine visits at five French university hospital geriatrics/memory clinics.
The source population comprises older adults followed in these services who live mainly at home or in hospital-based residential settings. The study focuses exclusively on patients with mild neurocognitive disorder or mild dementia, and includes individuals with mild depression.
Description
Inclusion Criteria:
- Men and women over 60 years of age.
- DSM-5 diagnosis: Early stage of major neurocognitive disorders or MCI (Mild Cognitive Impairment) including all underlying causes.
- Have a Mini-Mental State Exam score of 21 ≤ MMSE ≤ 28.
- Presence of mild or moderate depression, or presence of mild or moderate apathy, or presence of both
- Displays the necessary physical and cognitive abilities, without major limitations compromising interaction with the digital tool.
- Having voluntarily and informedly agreed to participate in the study (signed written consent).
- Subject's ability to hear and see the digital tool's stimuli (tests integrated into the tool).
- Patients with access to an Apple device (smartphone or tablet), either personal or provided by the sponsor, running iOS version 16 or higher, with internet access.
- Patient has at least one close referent who declares their wish to contribute to the collection of biographical information via the digital messaging group.
- Subjects covered by a social security scheme.
Exclusion Criteria:
- Patients with moderate or severe dementia (MMSE score ≤ 20) because implicit memory recall is less effective in moderate or severe stages for people with PWD.
- Presence of major psychiatric disorders (e.g., schizophrenia, severe major depressive episode, bipolar disorder).
- Major hearing or visual impairments.
- History of premorbid intellectual disability.
- Patients under guardianship, conservatorship, or legal protection.
- Patients who have already used the Lilia app
- Participating simultaneously in another study involving human subjects, a clinical investigation, or a therapeutic trial for the entire duration of the study.
- Patients who have received a new treatment related to neurocognitive disorders (medication) during the 3 months prior to the inclusion visit.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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DRT Users
Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: Baseline, Day 25, Day 50.
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale of depressive symptom severity. Possible scores range from 0 to 60, with higher scores indicating more severe depression. Decrease of MADRS total score between two measurement points indicates improvement over time. Unit of Measure: points (from 0 to 60) |
Baseline, Day 25, Day 50.
|
|
Change in Lille Apathy Rating Scale (LARS) Total Score
Time Frame: Baseline, Day 25, Day 50.
|
The Lille Apathy Rating Scale (LARS) is a clinician-rated questionnaire assessing apathy with a total score from -36 to +36. Higher scores indicating greater apathy. Decrease of LARS total score between two measurement points indicates improvement over time. Unit of Measure: points (from -36 to +36). |
Baseline, Day 25, Day 50.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in The Short Form Survey (SF-36) Global Score.
Time Frame: Baseline, Day 25, Day 50.
|
The Short Form Survey (SF-36) measures health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health status. Increase of SF-36 global score between two measurement points indicates improvement over time. Unit of Measure: Points on SF-36 scale from 0 to 100. |
Baseline, Day 25, Day 50.
|
|
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time Frame: Baseline, Day 25, Day 50.
|
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire evaluating sleep quality with scores from 0 to 21, with higher scores indicating worse sleep quality. Decrease of PSQI global score between two measurement points indicates improvement over time. Unit of Measure: Points on PSQI scale from 0 to 21. |
Baseline, Day 25, Day 50.
|
|
Number of Sessions Completed
Time Frame: From Baseline to Day 25
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Counting the number of sessions completed by the patient between Baseline and Day 25. Higher numbers are indicating greater adherence to the application use. Unit of Measure: Number of Sessions Completed |
From Baseline to Day 25
|
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Average Self-Reported Session Duration
Time Frame: From Baseline to Day 25.
|
Average self-reported session duration is the approximate average time spent per session with using the Lilia application between Baseline and Day 25 based on the patients' own observations. It is measured by a dedicated question: "On average, how much time did you spend with Lilia when you used it?" (response options: "Less than 5 minutes," "5-10 minutes," "More than 10 minutes"). Higher values refers to longer average sessions. Unit of Measure: average minutes per session |
From Baseline to Day 25.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cédric Annweiler, Geriatrician, PhD neuroscience, Angers University Hospital Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01382-47_PROTOCOLE_v3.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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