Alzheimer Disease or Associated DisorderNCT06781645
Evaluation of the Effects of Serious Cognitive Games on a Digital Tactile Table for Elderly People with Alzheimer's Disease or Related Disorders
A study testing 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 in people with Alzheimer Disease or Associated Disorder, run by RIVAGES.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease or Associated Disorder
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Person with severe neurocognitive disorders (MMSE < 15/30)
- Person refusing to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- 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
- Keywords
- serious games, interactive digital table, Alzheimer disease, Old people, cognitive stimulation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 memoryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| programme A, with digital table | Experimental | Not described Receives: 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about 3 months
Secondary outcomes (3)
Hospital Anxiety and Depression Scale
This 14-item scale gives two scores for anxiety and depression, each out of 21 points. A score of more than 11 indicates anxiety or depression.
Measured: about 3 months
the Occupational Therapy Engagement Scale
This 12-item scale can range from 0 to 36 points. The lower the score, the more difficult it is for the person to engage in therapeutic activities, and vice versa.
Measured: about 3 months
scale for rating the person being helped during an interaction with a caregiver
A 10-item scale, with scores ranging from 10 to 20. The lower the score, the less engaged in the activity, and vice versa.
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease or Associated DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomised crossover trial
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RIVAGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781645
- Sponsor's protocol ID
- 2024-A02676-41
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35461471Zhao 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.
PubMed 26540080
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06781645
- Acronym / sponsor ID
- 2024-A02676-41
- Conditions
- Alzheimer Disease or Associated Disorder
- Keywords
- serious games, interactive digital table, Alzheimer disease, Old people, cognitive stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- RIVAGESUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Person with severe neurocognitive disorders (MMSE < 15/30)
- Person refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 memoryEach 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. | Other | programme A, with digital table |
Primary outcome
Rosenberg Self-Esteem Scale
Time frame: about 3 months
40-point scale: the higher the score, the higher the self-esteem, and the lower the score, the lower the self-esteem.
3 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: about 3 months
the Occupational Therapy Engagement Scale
Time frame: about 3 months
scale for rating the person being helped during an interaction with a caregiver
Time frame: about 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 35461471Botto 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.
- Background: PubMed 26540080Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Alzheimer Disease or Associated Disorder, run by RIVAGES.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Pariel, Doctor (00 331 49 59 43 76, sylvie.pariel@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rosenberg Self-Esteem Scale (time frame: about 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781645, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.