NCT06068361

Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Dementia with Lewy body disease (DLB) is the second leading cause of degenerative cognitive disorder after Alzheimer's 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.

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). * 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).

Conditions

• Lewy Bodies Disease
• Alzheimer Disease
• Cognitive Impairment

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EEG	32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap

Timeline

• Start date: 2024-09-11
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-10-05
• Last updated: 2025-03-27

Locations

1 site across 1 country: France