Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders

NCT ID: NCT07237009

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-14

Study Completion Date

2026-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DRT Users

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

No interventions assigned to this group

Eligibility Criteria

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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 ≤ 26.
* Presence of mild depression, or presence of mild 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, moderate to 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 or other) during the 3 months prior to the inclusion visit.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Units Hungary

OTHER

Sponsor Role collaborator

KompanionCare SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cédric Annweiler, Geriatrician, PhD neuroscience

Role: STUDY_CHAIR

Angers University Hospital Center

Locations

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CHU Angers, Service médecine gériatrique.

Angers, , France

Site Status RECRUITING

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

Limoges, , France

Site Status RECRUITING

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

Nice, , France

Site Status RECRUITING

APHP Hôpitaux universitaires Paris centre.

Paris, , France

Site Status NOT_YET_RECRUITING

CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau.

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Peter MARKUS

Role: CONTACT

+36303621811

Facility Contacts

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Pr Cédric Annweiler

Role: primary

(+33) 241 35 54 86

Pr Achille Tchalla

Role: primary

+33 (0)5 55 05 88 94

Pr Guillaume Sacco

Role: primary

+33 (0)4 92 03 47 78

Pr Olivier Hanon

Role: primary

+33 (0) 1 44 08 33 81

Pr Bertrand Fougère

Role: primary

+33 (0)2 47473713

Other Identifiers

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2025-A01382-47_PROTOCOLE_v3.0

Identifier Type: -

Identifier Source: org_study_id

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