Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-29 @ 12:36 PM
Study NCT ID:
NCT05761535
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of a performant multiparametric system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease', 'timeFrame': '1-36 months', 'description': 'Collection and processing of multimodal imaging data and biological samples in patients with Dementia; Development of the Informatics Platform to support the interpretation of data in clinical setting'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodegenerative Diseases']}, 'descriptionModule': {'briefSummary': 'The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD)", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD)\n\nExclusion Criteria:\n\nAll patients for whom there are contraindications to performing MRI. Also excluded from the study will be subjects who are pregnant, or presumed to be pregnant or undergoing of lactation and subjects with claustrophobia'}, 'identificationModule': {'nctId': 'NCT05761535', 'acronym': 'BigImAGING', 'briefTitle': 'Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS SYNLAB SDN'}, 'officialTitle': 'Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia', 'orgStudyIdInfo': {'id': '6/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neurological disease patients', 'description': "150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD) for MRI and PET examinations and laboratory medicine", 'interventionNames': ['Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses']}, {'label': 'healthy subjects', 'description': 'Healthy subjects', 'interventionNames': ['Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses']}], 'interventions': [{'name': 'Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses', 'type': 'RADIATION', 'description': 'Regarding the neurological MR protocol, the following may be acquired:\n\n* 3D T1 and T2 high-resolution sequences, acquired in a specific plane and Multiplanar reformation (MPR) reconstructed in the remaining orthogonal planes, for morphological assessment of the different structures under examination;\n* diffusion sequences for the evaluation of the connection between different areas within a specific organ;\n* perfusion sequences (ASL, arterial spin labeling) for the evaluation of perfusion without ev mdc administration;\n* susceptibility sequences for noninvasive assessment of vasculature and deposits of iron.', 'armGroupLabels': ['healthy subjects', 'neurological disease patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80143', 'city': 'Naples', 'country': 'Italy', 'facility': 'IRCCS Synlab SDN', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS SYNLAB SDN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}