Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2025-12-17 @ 11:13 AM
Study NCT ID:
NCT06068361
Status:
None
Last Update Posted:
2025-03-27 00:00:00
First Post:
2023-09-29 00:00:00
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:
None
Status Verified Date:
2025-03
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:
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).
* 4 dry electrode EEG cap simultaneously with the 32-electrode EEG
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).
* 4 dry electrode EEG cap simultaneously with the 32-electrode EEG
Expected results: Improved DLB diagnosis performance using a combination of multimodal biomarkers (EEG, cognitive scores, plasma, brain MRI).
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 |