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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COGNUM_ALZVR
Sponsored by
RIVAGES
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-related Cognitive Decline focused on measuring tablet, smartwatch, diagnosis

Eligibility Criteria

60 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital Privé Gériatrique Les MagnoliasRecruiting
  • Hôpital Charles FoixRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity, specificity, accuracy
Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2023
Last Updated
September 8, 2023
Sponsor
RIVAGES
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université d'Évry, Hôpital Charles Foix
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1. Study Identification

Unique Protocol Identification Number
NCT06032611
Brief Title
Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.
Official Title
Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
April 17, 2024 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RIVAGES
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Université d'Évry, Hôpital Charles Foix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline, Computers, Handheld, Neurocognitive Disorders
Keywords
tablet, smartwatch, diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
COGNUM_ALZVR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity, specificity, accuracy
Description
Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joël Belmin
Phone
0149594565
Email
j.belmin@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathavy Um Din
Phone
0149594568
Email
nathavy.umdin@gmail.com
Facility Information:
Facility Name
Hôpital Privé Gériatrique Les Magnolias
City
Ballainvilliers
State/Province
Essonne
ZIP/Postal Code
91160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Maronnat
Facility Name
Hôpital Charles Foix
City
Ivry-sur-Seine
State/Province
Val De Marne
ZIP/Postal Code
94200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joël Belmin
First Name & Middle Initial & Last Name & Degree
Nathavy Um Din

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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