Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

Recruiting

• Conditions: Cognitive Impairment; Lewy Bodies Disease; Alzheimer Disease
• Interventions: Diagnostic Test: EEG

• Registration Number: NCT06068361
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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).

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-05
• Study Start: 2024-09-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AD patients	EEG	Alzheimer's disease according to McKhann et al., 2011 criteria including CSF biomarkers (an abnormal level of beta-amyloid 1-42 protein \[Ab42\] or a pathological Ab42/Ab40 ratio and an abnormal level of phosphorylated tau \[p-tau\])
DLB patients	EEG	Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017
Control	EEG	Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of a composite multimodal score	24 month	Diagnostic performance (sensitivity, specificity, accuracy) of a composite multimodal score combining quantitative EEG metrics, plasma biomarkers, MRI volumetric markers and cognitive scores, to differentiate groups of patients (AD, DLB) and control subjects.

Secondary Outcome Measures

Name	Time	Method
Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters.	24 month
Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls)	24 month
Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap	24 month

Trial Locations

Locations (1)

Centre de neurologie Cognitive; 🇫🇷 Paris, France