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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03811184
Other study ID # 2018-A02672-53
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 17, 2019
Est. completion date June 2020

Study information

Verified date January 2019
Source MemScreen
Contact Julien Dumurgier, MD
Phone 0033140054313
Email julien.dumurgier@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 2020
Est. primary completion date March 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

Diagnostic Test:
MemScreen
Neuropsychological test on smartphone or digital tablet, on self assesment.

Locations

Country Name City State
France Centre Neurologie Cognitive Hôpital Fernand Widal Paris

Sponsors (1)

Lead Sponsor Collaborator
MemScreen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to detect patients with mild cognitive impairment. 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
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