Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders

NCT ID: NCT06781645

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-12-31

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.

Conditions

Alzheimer Disease or Associated Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

programme A, with digital table

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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 B, without digital table

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RIVAGES

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sylvie Pariel, Doctor

Role: CONTACT

sylvie.pariel@aphp.fr

00 331 49 59 43 76

Joël Belmin, Professor

Role: CONTACT

j.belmin@gmail.com

00331 49 59 45 65

References

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.

Reference Type: BACKGROUND

PMID: 35461471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26540080 (View on PubMed)

Other Identifiers

2024-A02676-41

Identifier Type: -

Identifier Source: org_study_id