NCT04142801

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 5, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

October 19, 2019

Last Update Submit

October 26, 2019

Conditions

Neurocognitive Disorders

Keywords

Cognitionmotivationtechnologynon pharmacological intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in attention is is being assessed with the DSST

    Base line, Week 12

  • Change in frontal functioning is being assessed with the FAB

    Base line, Week 12

  • Change in behavior is being assessed with the NPI

    Base line, Week 12

  • IA-C

    Base line, Week 12

Study Arms (2)

MeMo group

EXPERIMENTAL

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.

Device: MeMo web application

Control group

PLACEBO COMPARATOR

Regular follow up at the memory center without cognitive training

Other: Control group

Interventions

MeMo web applicationDEVICE

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.

MeMo group
Control groupOTHER

the patient have the classical follow up at the memory center (consultation)

Control group

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CoBtek lab, Institut Claude Pompidou

Nice, 06100, France

Location

Related Publications (1)

  • 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.

    PMID: 32159519DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomization for the allocation of the patient in each group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: regular use of a web application at home to train cognition and behavior
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 29, 2019

Study Start

May 5, 2017

Primary Completion

February 2, 2019

Study Completion

August 10, 2019

Last Updated

October 29, 2019

Record last verified: 2019-10

Locations

FR(1)