Health TrialsbyHealthPanel

Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

ConditionsLewy Bodies DiseaseAlzheimer DiseaseCognitive Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-85
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • EEG

    Diagnostic test

    32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: DLB patients1 intervention
Group B: AD patients1 intervention
Group C: Control1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 month

Secondary outcomes

1

Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters.

Time frame
24 month
2

Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls)

Time frame
24 month
3

Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap

Time frame
24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Association des Aidants et Malades à Corps de Lewy (A2MCL)

Collaborator

Source ClinicalTrials.gov
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