Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-29 @ 12:03 PM
Study NCT ID:
NCT06068361
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2023-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004569', 'term': 'Electroencephalography'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-09-29', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of a composite multimodal score', 'timeFrame': '24 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comparison between groups of patients and controls of a composite EEG score combining several quantitative EEG parameters.', 'timeFrame': '24 month'}, {'measure': 'Correlation between EEG parameters, biological biomarkers, MRI volumetric markers and cognitive scores assessed in the three groups (DLB, AD, controls)', 'timeFrame': '24 month'}, {'measure': 'Reproducibility of 32-electrode EEG results with the 4 dry electrodes EEG cap', 'timeFrame': '24 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG', 'MRI', 'Plasma biomarkers'], 'conditions': ['Lewy Bodies Disease', 'Alzheimer Disease', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "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).\n\nStudies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning.\n\nThe 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.", 'detailedDescription': '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.\n\nAct :\n\n* 32-electrode EEG (resting state, passive auditory and active visual task).\n* 4 dry electrode EEG cap simultaneously with the 32-electrode EEG\n\nExpected results: Improved DLB diagnosis performance using a combination of multimodal biomarkers (EEG, cognitive scores, plasma, brain MRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for DLB ant AD patients:\n\n* Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)\n* 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\\])\n\nInclusion Criteria for control patients:\n\n* Neuropsychological assessment possible (good level in French language, absence of visual/auditory deficit limiting the cognitive assessment)\n* MMSE (Mini-mental State Examination) greater than or equal to 28, normal MemScreen test results, normal brain MRI and normal neurological examination\n\nExclusion Criteria (for all) :\n\n* Contraindication to MRI\n* Other neurological or psychiatric or toxic/iatrogenic disorders that may account for the cognitive impairment or for EEG abnormalities\n* Any unstable medical pathology and/or that may account for the cognitive impairment'}, 'identificationModule': {'nctId': 'NCT06068361', 'acronym': 'EEG-EDELY', 'briefTitle': 'Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Diagnostic Evaluation of Dementia with Lewy Bodies Using a Multimodal Approach: EEG, Cognitive, Biological and MRI Biomarkers', 'orgStudyIdInfo': {'id': 'APHP231168'}, 'secondaryIdInfos': [{'id': '2023-A00961-44', 'type': 'OTHER', 'domain': 'ID RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'DLB patients', 'description': 'Dementia with Lewy bodies according to the revised criteria of Mc Keith 2017', 'interventionNames': ['Diagnostic Test: EEG']}, {'label': 'AD patients', 'description': "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\\])", 'interventionNames': ['Diagnostic Test: EEG']}, {'label': 'Control', 'description': 'Subjective cognitive complaint, with a normal brain MRI and neurological examination, without any elements in favor of a neurodegenerative disease', 'interventionNames': ['Diagnostic Test: EEG']}], 'interventions': [{'name': 'EEG', 'type': 'DIAGNOSTIC_TEST', 'description': '32-electrode EEG (resting state, passive auditory and active visual task) + simultaneous recording with a 4 dry electrode EEG cap', 'armGroupLabels': ['AD patients', 'Control', 'DLB patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire PAQUET, MDPhD', 'role': 'CONTACT', 'email': 'claire.paquet@aphp.fr', 'phone': '0140054313', 'phoneExt': '33'}], 'facility': 'Centre de neurologie Cognitive', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Claire PAQUET, MDPhD', 'role': 'CONTACT', 'email': 'claire.paquet@aphp.fr', 'phone': '0140054313', 'phoneExt': '33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association des Aidants et Malades à Corps de Lewy (A2MCL)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}