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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB2022-A00609-34 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Université d'Évry | OTHER |
| Hôpital Charles Foix | OTHER |
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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:
There is no comparison group.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COGNUM_ALZVR | Diagnostic Test | Participants will complete a battery of tests/quizzes:
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, accuracy | Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joël Belmin | Contact | 0149594565 | j.belmin@aphp.fr | |
| Nathavy Um Din | Contact | 0149594568 | nathavy.umdin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Gériatrique Les Magnolias | Recruiting | Ballainvilliers | Essonne | 91160 | France |
Personal data is password-protected and not shared; only investigators have access to this data. Study data that is shared is pseudonymized by a unique alphanumeric code generated by the application.
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| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hôpital Charles Foix | Recruiting | Ivry-sur-Seine | Val De Marne | 94200 | France |
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