Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders

NCT07237009 | Recruiting

• 1 other identifier: 2025-A01382-47_PROTOCOLE_v3.0
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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. 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).

Conditions

Cognitive Impairment, Mild; Depression Mild; Apathy; Apathy in Dementia; Neurocognitive Disorders, Mild

Keywords

Mild Cognitive Impairment; Dementia; Apathy; Mild Depression; Digital Reminiscence therapy; personalized Reminiscence therapy

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

  Baseline, Day 25, Day 50.

Secondary Outcomes (4)

• Change in The Short Form Survey (SF-36) Global Score.

  Baseline, Day 25, Day 50.

• Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline, Day 25, Day 50.

• Number of Sessions Completed

  From Baseline to Day 25

• Average Self-Reported Session Duration

  From Baseline to Day 25.

Study Arms (1)

DRT Users

Single observational cohort exposed to a personalized digital reminiscence therapy, through daily 10-15 minute sessions.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KompanionCare SAS: lead
• Clinical Research Units Hungary: collaborator

Study Sites (5)

CHU Angers, Service médecine gériatrique.

Angers, 49 933, France

RECRUITING

Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department

Limoges, 87042, France

RECRUITING

Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Ressources et de Recherches (CM2R)

Nice, 06100, France

RECRUITING

APHP Hôpitaux universitaires Paris centre.

Paris, 75013, France

NOT YET RECRUITING

CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau.

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders; Cognitive Dysfunction; Lethargy; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Cédric Annweiler, Geriatrician, PhD neuroscience

  Angers University Hospital Center

  STUDY CHAIR

Central Study Contacts

Peter MARKUS

CONTACT

+36303621811; peter@kompanioncare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 19, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

FR (5)