Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.
2 other identifiers
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2023
CompletedFirst Submitted
Initial submission to the registry
September 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2024
CompletedSeptember 13, 2023
September 1, 2023
1 year
September 1, 2023
September 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RIVAGESlead
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- Université d'Évrycollaborator
- Hôpital Charles Foixcollaborator
Study Sites (2)
Hôpital Privé Gériatrique Les Magnolias
Ballainvilliers, Essonne, 91160, France
Hôpital Charles Foix
Ivry-sur-Seine, Val De Marne, 94200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2023
First Posted
September 13, 2023
Study Start
April 17, 2023
Primary Completion
April 17, 2024
Study Completion
April 17, 2024
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
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.