Clinical trial NCT06781645: Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders
Official title: Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease or Associated Disorder
Keywords: serious games
interactive digital table
Alzheimer disease
Old people
cognitive stimulation
Lead sponsor: RIVAGES
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 46
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomised crossover trial
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Rosenberg Self-Esteem Scale
timeFrame: about 3 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: about 3 months
measure: the Occupational Therapy Engagement Scale
timeFrame: about 3 months
measure: scale for rating the person being helped during an interaction with a caregiver
timeFrame: about 3 months
Other outcomes:
measure: the French version of the System Usability Scale
timeFrame: about 1 month
Locations:
Study officials:
References:
citation: 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.
citation: 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.