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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
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• 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 \[p-tau\])

• 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

Locations
Other Locations
France
Centre de neurologie Cognitive
RECRUITING
Paris
Contact Information
Primary
Claire PAQUET, MDPhD
claire.paquet@aphp.fr
0140054313
Time Frame
Start Date: 2024-09-11
Estimated Completion Date: 2027-09
Participants
Target number of participants: 130
Treatments
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
Sponsors
Collaborators: Association des Aidants et Malades à Corps de Lewy (A2MCL)
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov