Alzheimer Disease, Cognitive Impairment, Lewy Bodies Disease
Conditions
Keywords
EEG, MRI, Plasma biomarkers
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).
Interventions
DIAGNOSTIC_TESTEEG
32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap
Sponsors
Association des Aidants et Malades à Corps de Lewy (A2MCL)
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
| Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap | 24 month |
Countries
France
Contacts
Primary ContactClaire PAQUET, MDPhD
Outcome results
None listed