Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joël Belmin
- Phone Number: 0149594565
- Email: j.belmin@aphp.fr
Study Contact Backup
- Name: Nathavy Um Din
- Phone Number: 0149594568
- Email: nathavy.umdin@gmail.com
Study Locations
-
-
Essonne
-
Ballainvilliers, Essonne, France, 91160
- Recruiting
- Hôpital Privé Gériatrique Les Magnolias
-
Contact:
- Florian Maronnat
-
-
Val De Marne
-
Ivry-sur-Seine, Val De Marne, France, 94200
- Recruiting
- Hôpital Charles Foix
-
Contact:
- Joël Belmin
-
Contact:
- Nathavy Um Din
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will complete a battery of tests/quizzes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity, specificity, accuracy
Time Frame: through study completion, an average of 1 year
|
Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COGNUM
- IDRCB2022-A00609-34 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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