NCT03208491

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
17mo left

Started Sep 2017

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Sep 2017Dec 2027

First Submitted

Initial submission to the registry

June 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 26, 2017

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • cost utility ratio

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

    at 3 months

Study Arms (2)

serious games

EXPERIMENTAL
Other: serious games use

usual care

ACTIVE COMPARATOR
Other: usual care

Interventions

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

serious games

usual care of patient

usual care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, France

Location

Related Publications (1)

  • 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.

    PMID: 34013018BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 5, 2017

Study Start

September 30, 2017

Primary Completion

March 30, 2018

Study Completion (Estimated)

December 30, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations