Diagnostic Evaluation of Dementia With Lewy Bodies Using a Multimodal Approach

Alzheimer Disease Clinical Trial

— EEG-EDELY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068361
• Other study ID #: APHP231168
• Secondary ID: 2023-A00961-44
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire PAQUET, MDPhD
• Phone: 0140054313
• Email: claire.paquet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Expected results: Improved DLB diagnosis performance using a combination of multimodal biomarkers (EEG, cognitive scores, plasma, brain MRI).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Impairment
• Dementia
• Lewy Bodies Disease
• Lewy Body Disease

Intervention

Diagnostic Test:
• EEG
32-electrode EEG (resting state, passive auditory and active visual task)

Locations

Country	Name	City	State
France	Centre de neurologie Cognitive	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association des Aidants et Malades à Corps de Lewy (A2MCL)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters.		24 month
Secondary	Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls)		24 month