EEG-EDELY: Diagnostic Evaluation of Dementia With Lewy Bodies Using a Multimodal Approach

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06068361

Collaborator

Association des Aidants et Malades à Corps de Lewy (A2MCL) (Other)

130

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lewy Bodies Disease Alzheimer Disease Cognitive Impairment	Diagnostic Test: EEG

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
DLB patients Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017	Diagnostic Test: EEG 32-electrode EEG (resting state, passive auditory and active visual task)
AD patients 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])	Diagnostic Test: EEG 32-electrode EEG (resting state, passive auditory and active visual task)
Control Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease	Diagnostic Test: EEG 32-electrode EEG (resting state, passive auditory and active visual task)

Arm

Intervention/Treatment

DLB patients

Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017

Diagnostic Test: EEG

32-electrode EEG (resting state, passive auditory and active visual task)

AD patients

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])

Diagnostic Test: EEG

32-electrode EEG (resting state, passive auditory and active visual task)

Control

Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease

Diagnostic Test: EEG

32-electrode EEG (resting state, passive auditory and active visual task)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for DLB ant AD patients:

Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)
Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017 or probable AD defined according to McKhann 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])

Inclusion Criteria for control patients:

Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)
MMSE (Mini-mental State Examination) greater than or equal to 28, normal MemScreen test results, normal brain MRI and normal neurological examination

Exclusion Criteria (for all) :

Contraindication to MRI
Other neurological or psychiatric or toxic/iatrogenic disorders that may account for the cognitive impairment or for EEG abnormalities
Any unstable medical pathology and/or that may account for the cognitive impairment