NCT06781645

Brief Summary

Alzheimer's disease and related disorders are chronic, progressive diseases that have a major impact on the lives of sufferers and their families. They lead to a decline in cognitive function and are associated with a loss of independence and quality of life for sufferers. The loss of autonomy associated with major cognitive disorders can lead to feelings of worthlessness and loss of self-esteem. People may feel sad, depressed and, above all, very anxious. When this anxiety is linked to relationships with others, it can become major social anxiety, which aggravates the negative feelings and contributes to the deleterious progression of the neurodegenerative disease. Feelings of low self-esteem and/or the anxiety that accompanies them cannot be treated solely by long-term psychotropic drugs, as these can worsen the disorders through iatrogenesis. In this context, non-drug approaches can be seen as an essential complement. Cognition-based therapies, including cognitive stimulation, are based on a neuroeducational approach that can be deployed at different stages of the disease, either individually or in groups. Other patient-centred cognitive stimulation techniques have also been developed. In recent years, research has focused on serious digital games, which seem to combine rehabilitation possibilities in a playful form, making it easier for patients to adhere to them. They can also be used to work on motor skills, spatial reference, reflexes and speed and potentially improve verbal and non-verbal learning. Several recent meta-analyses have shown that brain games are an innovative and potentially effective approach to cognitive training for elderly people with cognitive disorders. Based on the existing literature, experimenting with a serious digital cognitive game could potentially produce beneficial results by improving parameters such as self-esteem and anxiety in patients with early or moderate Alzheimer's disease or a related illness. As part of their weekly cognitive stimulation programme at the day hospital, they plan to use the interactive digital table 'Le Village' ©, which can be used to offer fun exercises on working memory, semantic memory, explicit memory and sensory memory, with game objectives focusing on reaction, reminiscence and dexterity. The digital table simulates a village, allowing 6 people to play simultaneously and interact. This digital table can be used for individual or group sessions.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 9, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

serious gamesinteractive digital tableAlzheimer diseaseOld peoplecognitive stimulation

Outcome Measures

Primary Outcomes (1)

  • Rosenberg Self-Esteem Scale

    40-point scale: the higher the score, the higher the self-esteem, and the lower the score, the lower the self-esteem.

    about 3 months

Secondary Outcomes (3)

  • Hospital Anxiety and Depression Scale

    about 3 months

  • the Occupational Therapy Engagement Scale

    about 3 months

  • scale for rating the person being helped during an interaction with a caregiver

    about 3 months

Other Outcomes (1)

  • the French version of the System Usability Scale

    about 1 month

Study Arms (2)

programme A, with digital table

EXPERIMENTAL
Other: The system involves a digital table with a tactile and interactive surface, providing several play areas. It simulates a village and offers different types of serious cognitive games: semantic memory

programme B, without digital table

NO INTERVENTION

Interventions

Each patient included will benefit from a series of 6 sessions of cognitive stimulation with the interactive digital table of cognitive games 'Le Village de Verdurable'©, and a series of 6 sessions of 'classic' weekly cognitive stimulation at the rate of one session per week, i.e. without the digital table and using the methods of cognitive stimulation normally used in the department. The weekly session used as a comparator in the usual condition will be a session based on concentration and attention with target finding or error finding. The order in which these 2 series of 6 sessions will be carried out will be defined randomly (by drawing lots) before the start of the trial.

programme A, with digital table

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Person aged ≥ 65 years
  • A person with Alzheimer's disease or a related disorder established by a full medical diagnosis according to DSM-5 criteria, at a mild to moderate stage defined by a Mini-Mental State (MMSE) ≥ 15/30
  • A person who regularly attends the day hospital at Charles Foix Hospital Persons able to give their consent to take part in the study

You may not qualify if:

  • Person with severe neurocognitive disorders (MMSE \< 15/30)
  • Person refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Botto R, Callai N, Cermelli A, Causarano L, Rainero I. Anxiety and depression in Alzheimer's disease: a systematic review of pathogenetic mechanisms and relation to cognitive decline. Neurol Sci. 2022 Jul;43(7):4107-4124. doi: 10.1007/s10072-022-06068-x. Epub 2022 Apr 23.

    PMID: 35461471BACKGROUND
  • Zhao QF, Tan L, Wang HF, Jiang T, Tan MS, Tan L, Xu W, Li JQ, Wang J, Lai TJ, Yu JT. The prevalence of neuropsychiatric symptoms in Alzheimer's disease: Systematic review and meta-analysis. J Affect Disord. 2016 Jan 15;190:264-271. doi: 10.1016/j.jad.2015.09.069. Epub 2015 Oct 24.

    PMID: 26540080BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Sylvie Pariel, Doctor

CONTACT

Joël Belmin, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This is a randomised crossover trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 17, 2025

Study Start

February 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share