Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT01325259
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FluoroAv45 Imaging Research-in Alzheimer's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Uptake Value Ratios (SUVr)', 'timeFrame': 'inclusion', 'description': 'Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET \\[F18\\]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.\n\nObjectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.\n\nSecondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.\n\nMethod: Prospective multicentric study. 65 patients expected to enter the study.\n\nPrimary outcome measure: Standard Uptake Volume ratios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI\n* 18 \\< MMS \\<= 28 for patients\n* 28 \\<= MMS for healthy volunteers\n* study period \\> 7 years\n* native language : french\n* signed informed consent\n* affiliated to a social security system\n\nExclusion Criteria:\n\n* alcoholism in medical history\n* diabetes\n* arterial hypertension (180/100 and more)\n* chronical pulmonary disease with hypoxis\n* cranial traumatism with loss of consciousness \\> 15 minutes\n* severe depressive syndrome or anxiety\n* psychiatric disease in medical history (excepted simple episodes of depression)"}, 'identificationModule': {'nctId': 'NCT01325259', 'acronym': 'FAIR-AD', 'briefTitle': "FluoroAv45 Imaging Research-in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': "Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'PHRN08-VC / FAIR AD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Alzheimer's disease", 'description': "30 patients suffering from Alzheimer's disease", 'interventionNames': ['Other: neuropsychologic assessment', 'Radiation: [18F]AV-45 PET', 'Radiation: 18-FDG PET', 'Other: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Cognitive Impairment', 'description': '20 patients suffering from Mild Cognitive Impairment', 'interventionNames': ['Other: neuropsychologic assessment', 'Radiation: [18F]AV-45 PET', 'Radiation: 18-FDG PET', 'Other: MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': '15 subjects with no cognitive impairment', 'interventionNames': ['Other: neuropsychologic assessment', 'Radiation: [18F]AV-45 PET', 'Radiation: 18-FDG PET', 'Other: MRI']}], 'interventions': [{'name': 'neuropsychologic assessment', 'type': 'OTHER', 'description': 'Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI', 'armGroupLabels': ["Alzheimer's disease", 'Control', 'Mild Cognitive Impairment']}, {'name': '[18F]AV-45 PET', 'type': 'RADIATION', 'description': 'intravenous injection of 4 MBq/kg of \\[18F\\]AV-45', 'armGroupLabels': ["Alzheimer's disease", 'Control', 'Mild Cognitive Impairment']}, {'name': '18-FDG PET', 'type': 'RADIATION', 'description': 'intravenous injection of 100 to 120 MBq of FDG', 'armGroupLabels': ["Alzheimer's disease", 'Control', 'Mild Cognitive Impairment']}, {'name': 'MRI', 'type': 'OTHER', 'description': 'Magnetic Resonance Imaging', 'armGroupLabels': ["Alzheimer's disease", 'Control', 'Mild Cognitive Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'university hospital of CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'University Hospital of Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Vincent Camus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}