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Recruiting NCT07237009

Effects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders

— Observational Neurocognitive Disorders, Mild Cognitive Impairment, Mild Depression Mild Apathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neurocognitive Disorders, Mild, Cognitive Impairment, Mild, Depression Mild, Apathy. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Personalized Reminiscence Sessions Delivered by a Digital Conversational Agent to Patients With Neurocognitive Disorders

Overview

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).

Primary outcome measures

  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [Time frame: Baseline, Day 25, Day 50.]
  • Change in Lille Apathy Rating Scale (LARS) Total Score [Time frame: Baseline, Day 25, Day 50.]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 5 centers
  • CHU Angers, Service médecine gériatrique. — Angers
  • Limoges University Hospital Center - Dupuytren Hospital], Geriatric medicine department — Limoges
  • Centre Hospitalier Universitaire de Nice - Institut Claude Pompidou, Centre Mémoire de Res — Nice
  • APHP Hôpitaux universitaires Paris centre. — Paris
  • CHU DE TOURS, Pôle Vieillissement, Hôpital Bretonneau. — Tours

Identifiers

NCT: NCT07237009 · 2025-A01382-47_PROTOCOLE_v3.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗