Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen (MemScreen)

August 14, 2019 updated by: MemScreen

The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions.

The initial evaluation is made most often by a doctor (general practitioner). In case of need for further examination, a neuropsychological report is made in consultation memory by a neuropsychologist, with further cognitive tests.

The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.

The purpose of this study is to validate this new neuropsychological test on tablet compared to the neuropsychological reference tests.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Characteristics of MemScreen :

  • Smartphone / tablet application developed by the Cognitive Neurology Center at Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.
  • The application is a self-test by the patient under the supervision of a doctor.
  • The doctor has an account to be able to pass the test to patients.
  • The tablet test is anonymous without the possibility to identify the patient.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • Centre Neurologie Cognitive Hôpital Fernand Widal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population seen on memory clinic for memory complaints.

Description

Inclusion Criteria:

  • Major patients followed in memory clinic.
  • Performing a neuropsychological assessment less than 6 months old.
  • No visual or motor deficiency impeding the use of a digital tablet.

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MemScreen
Each participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment.
Diagnostic test: MemScreen
Neuropsychological test on smartphone or digital tablet, on self assesment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to detect patients with mild cognitive impairment.
Time Frame: through study completion, an average of 6 months
To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemScreen

Investigators

  • Principal Investigator: Julien Dumurgier, MD, Cognitive Neurology Center of Lariboisiere Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02672-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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