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Active, not recruitingNCT03208491AZ@GAME-EcoUpdated Jun 15, 2026

AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders

An interventional study of serious games use and usual care in Alzheimer Disease, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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. 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

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Conditions studied

  • Alzheimer Disease

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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 136 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • history of epilepsy
  • major walking or balance disorder.
  • Subject without freedom by judicial or administrative decision
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    serious games

    Other: serious games use

  • Active comparator
    usual care

    Other: usual care

Interventions

  • Otherserious games use

    This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist

  • Otherusual care

    usual care of patient

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What researchers measure

Primary outcomes

  1. cost utility ratio

    Measurement of the incremental cost-utility ratio of the management of patients suffering from Alzheimer's disease

    Time frame: at 3 months

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Study locations

1 site
  • CHU de Nice
    Nice, France
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03208491
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Jul 5, 2017
Start date
Sep 30, 2017
Primary completion
Mar 30, 2018
Completion
Dec 30, 2027 (estimated)
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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