Neurocognitive Disorders, MildNCT07237009
Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders
An observational study of Neurocognitive Disorders, Mild and Cognitive Impairment, Mild, run by KompanionCare SAS at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- 14 Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Angers, Service médecine gériatrique.
Angers, 49 933
Pr Cédric Annweiler, (+33) 241 35 54 86, CeAnnweiler@chu-angers.fr
Cédric Annweiler, Geriatrician, PhD neuroscience
- Recruiting
Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department
Limoges, 87042
Pr Achille Tchalla, +33 (0)5 55 05 88 94, Achille.Tchalla@chu-limoges.fr
Achille Tchalla, PhD in medicine and CR
- Recruiting
Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Ressources et de Recherches (CM2R)
Nice, 06100
Dr Aurelie Mouton, +33 (0)4 92 03 47 70, mouton.a@chu-nice.fr
Aurelie Mouton, Neurologist
- Not yet recruiting
APHP Hôpitaux universitaires Paris centre.
Paris, 75013
Pr Olivier Hanon, +33 (0) 1 44 08 33 81, olivier.hanon@aphp.fr
Olivier Hanon, Professor of Geriatrics
- Recruiting
CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau.
Tours, 37044
Pr Bertrand Fougère, +33 (0)2 47473713, bertrand.fougere@univ-tours.fr
Bertrand Fougère, Medical Doctor in Geriatrics
About this study
Official title: 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.
Read more
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).
- Conditions
- Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild, Apathy, Apathy in Dementia
- Keywords
- Mild Cognitive Impairment, Dementia, Apathy, Mild Depression, Digital Reminiscence therapy, personalized Reminiscence therapy
- Medical subject headings
- Neurocognitive Disorders, Cognitive Dysfunction, Lethargy, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DRT Users | Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
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)
Measured: Baseline, Day 25, Day 50.
Change in Lille Apathy Rating Scale (LARS) Total Score
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).
Measured: Baseline, Day 25, Day 50.
Secondary outcomes (4)
Change in The Short Form Survey (SF-36) Global Score.
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.
Measured: Baseline, Day 25, Day 50.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
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.
Measured: Baseline, Day 25, Day 50.
Number of Sessions Completed
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
Measured: From Baseline to Day 25
Average Self-Reported Session Duration
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
Measured: From Baseline to Day 25.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start14 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive Disorders, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KompanionCare SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Units Hungary
- Responsible party
- Sponsor
- Investigators
- Cédric Annweiler, Geriatrician, PhD neuroscience, Study chair, Angers University Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237009
- Sponsor's protocol ID
- 2025-A01382-47_PROTOCOLE_v3.0
- Status last verified
- Mar 2026
- First submitted
- 24 Sep 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized Reminiscence Sessions Delivered by a Digital Conversational Agent to Patients With Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT07237009
- Acronym / sponsor ID
- 2025-A01382-47_PROTOCOLE_v3.0
- Conditions
- Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild, Apathy, Apathy in Dementia
- Keywords
- Mild Cognitive Impairment, Dementia, Apathy, Mild Depression, Digital Reminiscence therapy, personalized Reminiscence therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- KompanionCare SASIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Units Hungary
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRT Users | – | –Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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).
4 secondary outcomes
Change in The Short Form Survey (SF-36) Global Score.
Time frame: Baseline, Day 25, Day 50.
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline, Day 25, Day 50.
Number of Sessions Completed
Time frame: From Baseline to Day 25
Average Self-Reported Session Duration
Time frame: From Baseline to Day 25.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cédric Annweiler, Geriatrician, PhD neuroscience study chair
Angers University Hospital Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, Mild and Cognitive Impairment, Mild, run by KompanionCare SAS at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter MARKUS (+36303621811, peter@kompanioncare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline, Day 25, Day 50.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.