Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06032611
Other study ID # COGNUM
Secondary ID IDRCB2022-A00609
Status Recruiting
Phase N/A
First received
Last updated
Start date April 17, 2023
Est. completion date April 17, 2024

Study information

Verified date September 2023
Source RIVAGES
Contact Joël Belmin
Phone 0149594565
Email j.belmin@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date April 17, 2024
Est. primary completion date April 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 110 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
France Hôpital Privé Gériatrique Les Magnolias Ballainvilliers Essonne
France Hôpital Charles Foix Ivry-sur-Seine Val De Marne

Sponsors (4)

Lead Sponsor Collaborator
RIVAGES Hôpital Charles Foix, Institut National de la Santé Et de la Recherche Médicale, France, Université d'Évry

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05754567 - CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Not yet recruiting NCT03276377 - VItamin K Inhibition and NeurocoGnition (VIKING) N/A
Completed NCT04175223 - Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders N/A
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Recruiting NCT05732285 - A Pilot Randomized Controlled Trial: CoINTEGRATE N/A
Recruiting NCT04095962 - Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia N/A
Not yet recruiting NCT04113577 - COgilus Remediation in Alzheimer Patients (CORA)
Recruiting NCT06320639 - DRIVing Simulator and People With NeuroCognitive Disorders
Recruiting NCT06105320 - COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study N/A
Completed NCT03050385 - Cognitive Rehabilitation During Transcranial Direct Current Stimulation N/A
Active, not recruiting NCT06372002 - Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia N/A
Recruiting NCT05508789 - A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Phase 3
Recruiting NCT03926351 - High Dose Omega 3 in People at Risk for Dementia Phase 2
Recruiting NCT05504681 - Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
Completed NCT04168268 - Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium
Recruiting NCT04825847 - Neurocognitive Disorders After Major Surgery in Elderly N/A
Active, not recruiting NCT02958670 - Imaging Tau Deposition in the Brain of Elderly Subjects N/A
Enrolling by invitation NCT02652598 - Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD Phase 2
Completed NCT02825732 - MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint N/A