Clinical trial NCT06068361: Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
Official title: Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lewy Bodies Disease
Alzheimer Disease
Cognitive Impairment
Keywords: EEG
MRI
Plasma biomarkers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association des Aidants et Malades à Corps de Lewy (A2MCL)
First posted: 2023-10-05
Enrollment: 130
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic performance of a composite multimodal score
timeFrame: 24 month
Secondary outcomes:
measure: Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters.
timeFrame: 24 month
measure: Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls)
timeFrame: 24 month
measure: Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap
timeFrame: 24 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de neurologie Cognitive
Study officials:
References: