Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

NCT06068361 | Recruiting

• 2 other identifiers: APHP2311682023-A00961-44
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Lewy Bodies Disease; Alzheimer Disease; Cognitive Impairment

Keywords

EEG; MRI; Plasma biomarkers

Outcome Measures

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.

  24 month

Secondary Outcomes (3)

• 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

Study Arms (3)

DLB patients

Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017

Diagnostic Test: EEG

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 \[p-tau\])

Diagnostic Test: EEG

Control

Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease

Diagnostic Test: EEG

Interventions

EEG DIAGNOSTIC_TEST

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

AD patients; Control; DLB patients

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Association des Aidants et Malades à Corps de Lewy (A2MCL): collaborator

Study Sites (1)

Centre de neurologie Cognitive

Paris, France, 75010, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Claire PAQUET, MDPhD

CONTACT

0140054313; claire.paquet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: September 11, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)