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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208491
Recruitment Status : Unknown
Verified May 2017 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Not yet recruiting
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: serious games use Other: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AZ@GAME-Eco: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders
Estimated Study Start Date : September 30, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: serious games Other: serious games use
This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist

Active Comparator: usual care Other: usual care
usual care of patient




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208491


Contacts
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Contact: Vanina OLIVERI, PM 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03208491    
Other Study ID Numbers: 16-PRME-01
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders