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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
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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