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NCT Number: NCT06068361

Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de neurologie Cognitive

Paris, France, 75010

Location status: Recruiting

Location contact

Claire PAQUET, MDPhD

CONTACT

[email protected]

0140054313 ext. 33

About this study

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).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG

Diagnostic Test

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

Primary outcomes

  1. Diagnostic performance of a composite multimodal score

    Time frame: 24 month

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Claire PAQUET, MDPhD

CONTACT

[email protected]

0140054313 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EEG-EDELY

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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