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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00961-44 | Other Identifier | ID RCB number |
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| Name | Class |
|---|---|
| Association des Aidants et Malades à Corps de Lewy (A2MCL) | UNKNOWN |
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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.
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 :
Expected results: Improved DLB diagnosis performance using a combination of multimodal biomarkers (EEG, cognitive scores, plasma, brain MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLB patients | Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017 |
| |
| 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]) |
| |
| Control | Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG | Diagnostic Test | 32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap |
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| 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 |
| 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) |
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Inclusion Criteria for DLB ant AD patients:
Inclusion Criteria for control patients:
Exclusion Criteria (for all) :
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Observational prospective cohort study included 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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire PAQUET, MDPhD | Contact | 0140054313 | 33 | claire.paquet@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de neurologie Cognitive | Recruiting | Paris | France | 75010 | France |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| 24 month |
| Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap | 24 month |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |