Diagnostic Evaluation of Dementia With Lewy Bodies Using a Multimodal Approach

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Lewy Bodies Disease, Alzheimer Disease, Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: EEG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of a composite multimodal score | 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. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, MRI, Plasma biomarkers