Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06068361
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-09-29
Brief Title:
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach EEG Cognitive Biological and MRI Biomarkers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EEG-EDELY
Brief Summary:
Dementia with Lewy body disease DLB is the second leading cause of degenerative cognitive disorder after Alzheimers disease AD Its variable clinical expression makes diagnosis difficult To date there is no validated DLB diagnostic biomarker despite several biomarkers in development EEG MRI biology
Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning
The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB EEG MRI biology cognitive scores using a machine learning approach applied to a clinical cohort
Studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning
The aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of DLB EEG MRI biology cognitive scores using a machine learning approach applied to a clinical cohort
Detailed Description:
Study population Observational prospective cohort study including over 24 months at the GHU AP-HP Nord Lariboisière Cognitive Neurology Center 50 probable DLB patients 50 AD patients and 30 control subjects with subjective cognitive impairment but without any element in favor of neurodegenerative disorders Total clinical dataset n 130
Act 32-electrode EEG resting state passive auditory and active visual task
Expected results Improved DLB diagnosis performance using a combination of multimodal biomarkers EEG cognitive scores plasma brain MRI
Act 32-electrode EEG resting state passive auditory and active visual task
Expected results Improved DLB diagnosis performance using a combination of multimodal biomarkers EEG cognitive scores plasma brain MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00961-44 | OTHER | ID RCB number | None |