Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
NCT ID: NCT06068361
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
130 participants
OBSERVATIONAL
2024-09-11
2027-09-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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DLB patients
Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017
EEG
32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap
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 \[p-tau\])
EEG
32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap
Control
Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease
EEG
32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap
Interventions
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EEG
32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
55 Years
85 Years
ALL
No
Sponsors
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Association des Aidants et Malades à Corps de Lewy (A2MCL)
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Centre de neurologie Cognitive
Paris, France, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A00961-44
Identifier Type: OTHER
Identifier Source: secondary_id
APHP231168
Identifier Type: -
Identifier Source: org_study_id
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