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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04142801
Other study ID # 2016-A00879-42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2017
Est. completion date August 10, 2019

Study information

Verified date October 2019
Source Innovation Alzheimer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Memory, attentional, and behavioural symptoms are the clinical hallmarks of Neurocognitive disorders (NCD) such as Alzheimer's disease and related disorders. The World Health Organisation (WHO) guidelines for risk reduction of cognitive decline and dementia indicate that Cognitive training may be offered to older adults with normal cognition and with mild cognitive impairment to reduce the risk of cognitive decline and/or dementia. The use of Information and Communication Technologies (ICT) in the health domain is progressively expanding. The Alzheimer Innovation Association have developed MeMo (Memory Motivation) a free web application that can be used at home by patients.

The objective of the present study was to assess the effectiveness of employing the MeMo platform on cognitive performance in patients suffering from NCD.


Description:

The objective of this study is to evaluate the effectiveness of the MeMo cognitive training exercise platform in patients suffering from neurocognitive disorders. These exercises ,have been developed by the association Innovation Alzheimer and the CoBTeK research team, located with the Nice memory Center at the Institut Claude Pompidou. MeMo can be used freely at home by patients. More specifically, it is a randomized controlled study that aims to compare the evolution of activities cognition and behavior between patients not using these exercises, and patients using these exercises for 12 weeks, 4 sessions per week.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date August 10, 2019
Est. primary completion date February 2, 2019
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria:

- Outpatient consulting the Memory center

- older than 60 years old

- Mini Mental State examination score (MMSE) between 16 and 28 / 30

- met the DSM 5 diagnoses of mild neurocognitive disorders (mild NCD) or major neurocognitive disorders (Major NCD).

Exclusion Criteria:

- Patients not able to read and write French

- presence of a hearing or major visual impairment

- a history of premorbid mental retardation

- had already used the MeMo application

- were presently involved in structured memory training activities.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MeMo web application
The patient betwenn 2 consultation could use the application MeMo. MeMo is a web application that can thus be used on any web browser (computer or tablet). On tablet, the application can be installed on home screen to look like a native app, and used offline.
Other:
Control group
the patient have the classical follow up at the memory center (consultation)

Locations

Country Name City State
France CoBtek lab, Institut Claude Pompidou Nice

Sponsors (4)

Lead Sponsor Collaborator
Innovation Alzheimer Alzheimer's Association, Centre Hospitalier Universitaire de Nice, Université de Nice Sophia Antipolis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change is being assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) To score the IQCODE, add up the score for each question and divide by the number of questions. For the long IQCODE, divide by 26. Base line, Week 12
Secondary Change in attention is is being assessed with the DSST Digit Symbol Substitution Test (attentional task) Base line, Week 12
Secondary Change in frontal functioning is being assessed with the FAB the Frontal Assessment Battery: Score 0 (healthy) - 18 (pathology) Base line, Week 12
Secondary Change in behavior is being assessed with the NPI Neuropsychiatric Inventory score 0 (healthy) - 134 (pathology) Base line, Week 12
Secondary IA-C Change in motivation is being assessed with theApathy inventory, clinician version score 0 (healthy)- 12 (pathology) Base line, Week 12
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