Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 4:55 PM
Study NCT ID:
NCT01565356
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
2012-03-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of PET Scan Timing Relative to AV-45 Injection Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C545186', 'term': 'florbetapir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaloperations@avidrp.com', 'phone': '215-298-0700', 'title': 'Chief Medical Officer', 'organization': 'Avid Radiopharmaceuticals'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No subjects received florbetapir in this study. This study consisted of rereads of scans previously acquired in other clinical studies (A01,A03).', 'eventGroups': [{'id': 'EG000', 'title': 'All Subject Scans', 'description': '22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Scans', 'description': '22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Kappa statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.00', 'groupDescription': "Cohen's (simple) kappa statistic", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Scans acquired 30-40 min and 50-60 min after injection', 'description': 'Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.', 'unitOfMeasure': 'percentage of agreement', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Scans', 'description': '22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.946', 'groupId': 'OG000', 'lowerLimit': '0.906', 'upperLimit': '0.987'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Scans acquired 30-40 min and 50-60 min post-injection', 'description': 'Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.', 'unitOfMeasure': 'weighted kappa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subject Scans', 'description': '22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subject Scans', 'description': '22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.49', 'spread': '15.302', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2012-03-26', 'resultsFirstSubmitDate': '2012-04-06', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-03', 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation', 'timeFrame': 'Scans acquired 30-40 min and 50-60 min after injection', 'description': 'Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.'}], 'secondaryOutcomes': [{'measure': 'Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation', 'timeFrame': 'Scans acquired 30-40 min and 50-60 min post-injection', 'description': 'Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amyloid imaging', 'Positron Emission Tomography', '18F-AV-45', 'florbetapir F 18', 'Diagnostic imaging'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).\n\nInclusion Criteria (AD group):\n\n* Greater than 50 years of age\n* Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria\n* Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening\n* History of cognitive decline gradual in onset and progressive over a period of at least 6 months\n\nInclusion Criteria (A01\\[NCT01565291\\] healthy volunteer group):\n\n* 50 years of age, inclusive\n\n * MMSE of 29 or greater\n\nInclusion Criteria (A03\\[NCT01565330\\] healthy volunteer group):\n\n* 35 to 55 years of age, inclusive\n* MMSE of 29 or greater\n\nExclusion Criteria (both groups):\n\n* Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy\n* Diagnosis of other dementing / neurodegenerative disease\n* Diagnosis of mixed dementia\n* Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation\n* Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria\n* Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)\n* Clinically significant psychiatric disease\n* History of epilepsy or convulsions\n* Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances\n* Current clinically significant cardiovascular disease\n* Received investigational medication within the last 30 days"}, 'identificationModule': {'nctId': 'NCT01565356', 'briefTitle': 'Evaluation of PET Scan Timing Relative to AV-45 Injection Time', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': "Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients", 'orgStudyIdInfo': {'id': '18F-AV-45-A06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['18F-AV-45', 'Amyvid', 'florbetapir'], 'description': 'IV injection, 111 or 370MBq (3 or 10mCi), single dose'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}