Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.

NCT ID: NCT06032611

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2024-04-17

Brief Summary

The goal of this clinical trial is to compare conventional clinical data collected as part of usual practice with data collected by the two digital tools to help diagnose major and minor neurocognitive disorders in elderly people consulting a memory center for cognitive complaints. The main question[s] it aims to answer are:

• Is it possible to create a classification between the different intensities of cognitive impairment?
• Is it possible to create a diagnostic tool consistent with the reference diagnosis? Participants will be asked to complete a series of cognitive and fine motor tasks, and will be given questionnaires on their lifestyle and medical history. They will be asked to wear a connected watch for 1 week.

There is no comparison group.

Detailed Description

Alzheimer's disease, which leads to dementia, has an insidious onset and a slow, gradual progression. After a completely asymptomatic phase that can last several years (prodromal stage of the disease), the first signs consist of a moderate deterioration in performance in one or more cognitive domains, such as memory, attention, planning or other cognitive faculties. Clinically, this is referred to as mild neurocognitive impairment (MCI) due to Alzheimer's disease. The progression is towards a major neurocognitive disorder, in which cognitive dysfunction progressively increases, and the patient becomes dependent for activities of daily living. Early detection of the disease, and specifically of this mild neurocognitive disorder, is crucial for a window of intervention prior to dementia. The investigators propose to evaluate a tablet version of a manual dexterity test that the investigators have already been able to test, in combination with assessments already established in the clinic and physiological data collected by a connected watch, to help diagnose neurocognitive disorders by confronting them with the clinical data that are the reference.

The investigators propose this multicenter observational study with a diagnostic aim. The study will involve 150 elderly people consulting one of the two participating memory centers. Three groups will be formed: 50 people with no cognitive dysfunction, 50 with a mild neurocognitive disorder, and 50 with a major neurocognitive disorder linked to Alzheimer's disease. These groups will be formed on the basis of the reference diagnosis established by the memory consultation teams, and the results of the patient's neuropsychological and medical assessments. The investigators will retrieve data from the medical record to classify cognitive status.

Conditions

Age-related Cognitive Decline; Computers, Handheld; Neurocognitive Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will complete a number of cognitive and fine motor tests on a touch-sensitive tablet. They will also be asked to complete a questionnaire on their habits and medical history. They will also be asked to wear a smartwatch for 7 days.

Group Type: EXPERIMENTAL

COGNUM_ALZVR

Intervention Type: DIAGNOSTIC_TEST

Participants will complete a battery of tests/quizzes:

• cognitive tests
• medical questionnaire
• lifestyle/fragility questionnaire
• digital clock test
• fine motor skills tests They will also wear a connected watch for 7 days.

Interventions

COGNUM_ALZVR

Participants will complete a battery of tests/quizzes:

• cognitive tests
• medical questionnaire
• lifestyle/fragility questionnaire
• digital clock test
• fine motor skills tests They will also wear a connected watch for 7 days.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• elderly people consulting the memory center ;
• people with one of three documented cognitive diagnoses:
• major neurocognitive impairment due to Alzheimer's disease according to DSM-5 criteria,
• mild neurocognitive impairment
• no documented cognitive dysfunction after assessment at the memory center,
• willingness to participate in the study and sign the consent form.

Exclusion Criteria

• persons with an illness affecting the hand (orthopedic, neurological, Parkinson's disease) that prevents them from using a touch-sensitive tablet;
• persons with other illnesses that may be responsible for loss of cognitive function (cerebrovascular disease, other neurological illnesses, psychiatric illnesses);
• persons benefiting from legal protection.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Université d'Évry

OTHER

Sponsor Role: collaborator

Hôpital Charles Foix

OTHER

Sponsor Role: collaborator

RIVAGES

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Gériatrique Les Magnolias

Ballainvilliers, Essonne, France

Site Status: RECRUITING

Hôpital Charles Foix

Ivry-sur-Seine, Val De Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Joël Belmin

Role: CONTACT

j.belmin@aphp.fr

0149594565

Nathavy Um Din

Role: CONTACT

nathavy.umdin@gmail.com

0149594568

Facility Contacts

Florian Maronnat

Role: primary

Joël Belmin

Role: primary

Nathavy Um Din

Role: backup

Other Identifiers

IDRCB2022-A00609-34

Identifier Type: OTHER

Identifier Source: secondary_id

COGNUM

Identifier Type: -

Identifier Source: org_study_id