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Efficacy of the Memory Motivation (MEMO) Web Application Training (MeMo)

Primary Purpose

Neurocognitive Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MeMo web application
Control group
Sponsored by
Innovation Alzheimer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurocognitive Disorders focused on measuring Cognition, motivation, technology, non pharmacological intervention

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CoBtek lab, Institut Claude Pompidou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MeMo group

Control group

Arm Description

MeMo group: experimental: regular use at home of the Memo web application In the Memo group patients were instructed on how to use the application, and allowed to train for 12 weeks. It was also explained that this training needed to be done regularly on a basis of 4 sessions of 30 minutes each per week.

Regular follow up at the memory center without cognitive training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in attention is is being assessed with the DSST
Digit Symbol Substitution Test (attentional task)
Change in frontal functioning is being assessed with the FAB
the Frontal Assessment Battery: Score 0 (healthy) - 18 (pathology)
Change in behavior is being assessed with the NPI
Neuropsychiatric Inventory score 0 (healthy) - 134 (pathology)
IA-C
Change in motivation is being assessed with theApathy inventory, clinician version score 0 (healthy)- 12 (pathology)

Full Information

First Posted
October 19, 2019
Last Updated
October 26, 2019
Sponsor
Innovation Alzheimer
Collaborators
Alzheimer's Association, Centre Hospitalier Universitaire de Nice, Université de Nice Sophia Antipolis
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1. Study Identification

Unique Protocol Identification Number
NCT04142801
Brief Title
Efficacy of the Memory Motivation (MEMO) Web Application Training
Acronym
MeMo
Official Title
Efficacy of the Memory Motivation (MEMO) Web Application for Cognitive and Behavioral Training in Patients With Neurocognitive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
February 2, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Innovation Alzheimer
Collaborators
Alzheimer's Association, Centre Hospitalier Universitaire de Nice, Université de Nice Sophia Antipolis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders
Keywords
Cognition, motivation, technology, non pharmacological intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
regular use of a web application at home to train cognition and behavior
Masking
ParticipantInvestigator
Masking Description
Randomization for the allocation of the patient in each group
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MeMo group
Arm Type
Experimental
Arm Description
MeMo group: experimental: regular use at home of the Memo web application In the Memo group patients were instructed on how to use the application, and allowed to train for 12 weeks. It was also explained that this training needed to be done regularly on a basis of 4 sessions of 30 minutes each per week.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Regular follow up at the memory center without cognitive training
Intervention Type
Device
Intervention Name(s)
MeMo web application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
the patient have the classical follow up at the memory center (consultation)
Primary Outcome Measure Information:
Title
Change is being assessed with the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Description
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.
Time Frame
Base line, Week 12
Secondary Outcome Measure Information:
Title
Change in attention is is being assessed with the DSST
Description
Digit Symbol Substitution Test (attentional task)
Time Frame
Base line, Week 12
Title
Change in frontal functioning is being assessed with the FAB
Description
the Frontal Assessment Battery: Score 0 (healthy) - 18 (pathology)
Time Frame
Base line, Week 12
Title
Change in behavior is being assessed with the NPI
Description
Neuropsychiatric Inventory score 0 (healthy) - 134 (pathology)
Time Frame
Base line, Week 12
Title
IA-C
Description
Change in motivation is being assessed with theApathy inventory, clinician version score 0 (healthy)- 12 (pathology)
Time Frame
Base line, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CoBtek lab, Institut Claude Pompidou
City
Nice
ZIP/Postal Code
06100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32159519
Citation
Robert P, Manera V, Derreumaux A, Ferrandez Y Montesino M, Leone E, Fabre R, Bourgeois J. Efficacy of a Web App for Cognitive Training (MeMo) Regarding Cognitive and Behavioral Performance in People With Neurocognitive Disorders: Randomized Controlled Trial. J Med Internet Res. 2020 Mar 11;22(3):e17167. doi: 10.2196/17167.
Results Reference
derived

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Efficacy of the Memory Motivation (MEMO) Web Application Training

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