Alzheimer DiseaseAZ@GAME-EcoNCT03208491
AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
A study testing serious games use in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- serious games use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2017to 30 Dec 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 60 years of age;
- Subjects diagnosed with Alzheimer's Disease or related disorders associated with mild to moderately severe (CIM 10)
- a score between 12 and 24 on the Mini Mental score evaluation
- Subject treated in one of the participating centers
- To have the social welfare insurance
- Signature of the free and informed consent in the case of a patient under guardianship with signature of the guardian
Who cannot join
- history of epilepsy
- major walking or balance disorder.
- Subject without freedom by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.
Read the detailed description
With the aging of the population, Alzheimer's disease and associated disorders represent a major public health challenge. To date there is no pharmacological treatment to stop the degenerative process or behavioral disorders. This explains the importance of non-pharmacological approaches to stimulate cognition, reduce behavioral disorders or improve quality of life. Non-pharmacological therapies are the central focus of care, especially for patients accommodated on a part-time basis (Day Hospital, Respite Platform) or Full-Time nursing home (EHPAD in French). TNM also holds an important place for patients living at home, and belongs to the very general framework of informal care, which is a significant cost.
In France, the cost of taking care of patients over 75 with this type of pathology is estimated between 24.2 and 30 billion euros per year, which is more than cancer or cardiovascular disease.
At the same time, new information and communication technologies (ICTs) play an increasingly important part in our daily lives and can be a support in the field of health. In this context, ICTs are of great interest for evaluation, rehabilitation and assistance. At the level of care, the aim is to propose applications to train and / or stimulate cognitions, behavior and motivation. Serious Games (SG) are part of this framework.
Az @ GAME (Alzheimer's Disease and serious games), is the winner of the e-health project 2011-2015. This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist. The AZ @ GAME-ECO + study is a new and innovative step as it represents the first combined evaluation of the cost and usefulness of managing patients with Alzheimer's disease using the serious Games (SG). In AZ @ GAME-ECO + SGs are a new tool for institutions involved in patient care.
OBJECTIVES The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.
POPULATION Male or Female ≥ 60 years of age / with a diagnosis of Alzheimer's Disease or related disorders (CIM10) condition with a Mini Mental State Examination score between 12 and 24. Patients are monitored in one of the centers participating in the study (Day Hospital, nursing home, Memory Consultation).
METHOD This multi-center study involves 18 participating centers: Dependent Elderly Care Facilities (EHPAD), Day Care Centers, and Memory Centers, with the inclusion of 144 subjects (72 subjects per group and 8 subjects per center). It will be done in open form.
After randomization, the centers belonging to the intervention group use the SG for 3 months (2 sessions per week). The control group centers will be able to use the SG at the end of the study.
Medico-economic and clinical evaluations will be performed at baseline, at the end of the intervention (M3) and 3 months after the intervention (M6). An incremental cost-utility ratio will be calculated to compare the management with SG therapeutics and the usual management from a societal perspective and with a time horizon of 6 months.
BENEFITS To gain a better understanding of the medico-economic benefits and usability of a new technology to train cognitive, physical functions while promoting motivation and social engagement in Alzheimer's disease patients in situations Usual care in Daycare, Nursing home and Memory center.
PARTNERS Montpellier University Health Center / Groupe Genious / Alzheimer Innovation Association / Institut national de recherche en informatique et en automatique (INRIA) Sophia-Antipolis - STARS team
- Conditions
- Alzheimer Disease
- Being tested
- serious games use, usual care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious games useOther
This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist
usual careOther
usual care of patient
| Study group | Role | What they receive |
|---|---|---|
| serious games | Experimental | Not described Receives: Other: serious games use |
| usual care | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost utility ratio
Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start30 Sep 2017
- Primary completion30 Mar 2018
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208491
- Sponsor's protocol ID
- 16-PRME-01
- Acronym
- AZ@GAME-Eco
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robert P, Albrengues C, Fabre R, Derreumaux A, Pancrazi MP, Luporsi I, Dubois B, Epelbaum S, Mercier G, Foulon P, Bremond F, Manera V. Efficacy of serious exergames in improving neuropsychiatric symptoms in neurocognitive disorders: Results of the X-TORP cluster randomized trial. Alzheimers Dement (N Y). 2021 May 11;7(1):e12149. doi: 10.1002/trc2.12149. eCollection 2021.
PubMed 34013018
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
- ClinicalTrials.gov ID
- NCT03208491
- Acronym / sponsor ID
- AZ@GAME-Eco / 16-PRME-01
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 Jul 2017 (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.
The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.
Detailed description
With the aging of the population, Alzheimer's disease and associated disorders represent a major public health challenge. To date there is no pharmacological treatment to stop the degenerative process or behavioral disorders. This explains the importance of non-pharmacological approaches to stimulate cognition, reduce behavioral disorders or improve quality of life. Non-pharmacological therapies are the central focus of care, especially for patients accommodated on a part-time basis (Day Hospital, Respite Platform) or Full-Time nursing home (EHPAD in French). TNM also holds an important place for patients living at home, and belongs to the very general framework of informal care, which is a significant cost.
In France, the cost of taking care of patients over 75 with this type of pathology is estimated between 24.2 and 30 billion euros per year, which is more than cancer or cardiovascular disease.
At the same time, new information and communication technologies (ICTs) play an increasingly important part in our daily lives and can be a support in the field of health. In this context, ICTs are of great interest for evaluation, rehabilitation and assistance. At the level of care, the aim is to propose applications to train and / or stimulate cognitions, behavior and motivation. Serious Games (SG) are part of this framework.
Az @ GAME (Alzheimer's Disease and serious games), is the winner of the e-health project 2011-2015. This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist. The AZ @ GAME-ECO + study is a new and innovative step as it represents the first combined evaluation of the cost and usefulness of managing patients with Alzheimer's disease using the serious Games (SG). In AZ @ GAME-ECO + SGs are a new tool for institutions involved in patient care.
OBJECTIVES The main objective of AZ@GAME ECO is to evaluate the cost-utility of the management of patients suffering from Alzheimer's disease using a serious game providing cognitive and physical straining compared to a usual management. Among the secondary objectives it is important to assess the real life feasibility in different types of care structures.
POPULATION Male or Female ≥ 60 years of age / with a diagnosis of Alzheimer's Disease or related disorders (CIM10) condition with a Mini Mental State Examination score between 12 and 24. Patients are monitored in one of the centers participating in the study (Day Hospital, nursing home, Memory Consultation).
METHOD This multi-center study involves 18 participating centers: Dependent Elderly Care Facilities (EHPAD), Day Care Centers, and Memory Centers, with the inclusion of 144 subjects (72 subjects per group and 8 subjects per center). It will be done in open form.
After randomization, the centers belonging to the intervention group use the SG for 3 months (2 sessions per week). The control group centers will be able to use the SG at the end of the study.
Medico-economic and clinical evaluations will be performed at baseline, at the end of the intervention (M3) and 3 months after the intervention (M6). An incremental cost-utility ratio will be calculated to compare the management with SG therapeutics and the usual management from a societal perspective and with a time horizon of 6 months.
BENEFITS To gain a better understanding of the medico-economic benefits and usability of a new technology to train cognitive, physical functions while promoting motivation and social engagement in Alzheimer's disease patients in situations Usual care in Daycare, Nursing home and Memory center.
PARTNERS Montpellier University Health Center / Groupe Genious / Alzheimer Innovation Association / Institut national de recherche en informatique et en automatique (INRIA) Sophia-Antipolis - STARS team
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious games | Experimental | Other: serious games use |
| usual care | Active comparator | Other: usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female ≥ 60 years of age;
- Subjects diagnosed with Alzheimer's Disease or related disorders associated with mild to moderately severe (CIM 10)
- a score between 12 and 24 on the Mini Mental score evaluation
- Subject treated in one of the participating centers
- To have the social welfare insurance
Key exclusion criteria (3 listed)
- history of epilepsy
- major walking or balance disorder.
- Subject without freedom by judicial or administrative decision
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 |
|---|---|---|
| serious games useThis program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist | Other | serious games |
| usual careusual care of patient | Other | usual care |
Primary outcome
cost utility ratio
Time frame: at 3 months
Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease
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 15 Jun 2026.
- Background: PubMed 34013018Robert P, Albrengues C, Fabre R, Derreumaux A, Pancrazi MP, Luporsi I, Dubois B, Epelbaum S, Mercier G, Foulon P, Bremond F, Manera V. Efficacy of serious exergames in improving neuropsychiatric symptoms in neurocognitive disorders: Results of the X-TORP cluster randomized trial. Alzheimers Dement (N Y). 2021 May 11;7(1):e12149. doi: 10.1002/trc2.12149. eCollection 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious games use in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost utility ratio (time frame: at 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 NCT03208491, which also lists 1 linked publication.
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 15 Jun 2026.