Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-22 @ 12:55 AM
Study NCT ID:
NCT02752750
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2016-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], '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': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2016-04-19', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative magnetic susceptibility (QSM) in the human brain', 'timeFrame': '2 years', 'description': 'Reveal the dynamics of disease related brain iron deposition (by QSM in ppm) and its relation to disease progression and cognition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50 age-matched control subjects will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI). Regional differences of susceptibility and R2\\* relaxation rates in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline.", 'detailedDescription': "Abnormally increased brain iron accumulation in deep gray matter is a common finding in Alzheimer's disease (AD) and amyloid protein precursor and tau proteins were linked to disrupted iron homeostasis. Validation studies showed that brain iron can be measured precisely by the novel magnetic resonance imaging (MRI) technique quantitative susceptibility mapping (QSM) in vivo, thus, enabling reliable and precise longitudinal investigations.\n\nIt is hypothesized that pathologic brain iron accumulation can be assessed with higher sensitivity with QSM than with current MRI techniques such as R2\\* relaxation rate mapping and that regional QSM is a predictor for cognitive decline and disability.\n\nThis explorative longitudinal study is including 50 patients with AD and age-matched control subjects which will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla MRI. Regional differences of susceptibility and R2\\* in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline. Follow-up MRI and clinical data with multivariate regression analysis serve to investigate the dynamics of AD-related changes of susceptibility, and their relation to cognitive functioning.\n\nIn conclusion, this explorative longitudinal study in a patient cohort aims to clarify whether regional QSM changes are potential biomarkers for AD progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Alzheimer 's Disease", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of dementia according to DSM-IV and NINCDS-ADRDA criteria\n* the patient lives either with the family or has less than 40h/week of external care\n* the patients is able to understand the role in this study and is willing to participate\n* the physician in charge of this study confirms that the patients understands the study and its aims according to cognitive and clinical testing\n\nExclusion Criteria:\n\n* are other disorders\n* participation in a clinical drug trial (phase 1-3)'}, 'identificationModule': {'nctId': 'NCT02752750', 'briefTitle': "Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': "Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease", 'orgStudyIdInfo': {'id': 'QSM AD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AD_GROUP', 'description': "Patients with Alzheimer's disease", 'interventionNames': ['Other: MRI']}, {'label': 'HC_GROUP', 'description': 'Healthy controls', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'otherNames': ['Magnetic resonance imaging'], 'description': 'MR imaging (MRI) at 3 Tesla', 'armGroupLabels': ['AD_GROUP', 'HC_GROUP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christian Langkammer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}