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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable alzheimer-disease

Status
unknown

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

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 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

July 5, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

June 26, 2017

Last Update Submit

July 3, 2017

Conditions

Alzheimer Disease

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

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

serious games
usual careOTHER

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

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Vanina OLIVERI, PM

CONTACT

0033 4 92 03 42 54oliveri.v@chu-nice.fr

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

December 30, 2018

Last Updated

July 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share