Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-30 @ 1:56 AM
Study NCT ID:
NCT00855868
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
Sponsor:
Organization:
Raw JSON
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{'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': "Alzheimer's Disease", 'description': "Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \\>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90", 'otherNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls', 'description': 'Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Alzheimer's Disease", 'description': "Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \\>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90"}, {'id': 'OG001', 'title': 'Healthy Controls', 'description': 'Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.'}], 'classes': [{'title': 'Frontal cortex to cerebellum SUVR', 'categories': [{'measurements': [{'value': '1.33', 'spread': '.20', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '.18', 'groupId': 'OG001'}]}]}, {'title': 'Whole brain to cerebellum SUVR', 'categories': [{'measurements': [{'value': '1.38', 'spread': '.15', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 d', 'description': 'Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.', 'unitOfMeasure': 'SUVR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Alzheimer's Disease", 'description': "Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \\>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90"}, {'id': 'FG001', 'title': 'Healthy Controls', 'description': 'Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Alzheimer's Disease", 'description': "Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \\>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90"}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': 'Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '9.88', 'groupId': 'BG000'}, {'value': '71.5', 'spread': '9.23', 'groupId': 'BG001'}, {'value': '70.7', 'spread': '9.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'dispFirstSubmitDate': '2012-03-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2009-03-02', 'dispFirstSubmitQcDate': '2012-03-06', 'resultsFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2009-03-03', 'dispFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-19', 'studyFirstPostDateStruct': {'date': '2009-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.", 'timeFrame': '28 d', 'description': 'Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amyloid imaging', 'Positron Emission Tomography', '18F-AV-45', 'florbetapir F 18', 'Diagnostic imaging'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This study will evaluate the performance characteristics of a novel \\[18F\\] amyloid detection ligand (18F\\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \\[11C\\]PIB to correctly categorize the same subjects.\n\nSPECIFIC HYPOTHESES\n\n1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \\[18F\\]-AV-45 compared to cognitively normal elderly individuals.\n2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \\[18F\\]-AV-45 and \\[l1C\\]PIB.", 'detailedDescription': "15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \\[18F\\]-AV-45 and \\[11C\\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression\n* Alzheimer's subjects: MMSE 18-26, CDR \\>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI\n\nExclusion Criteria:\n\n* other neurological disease\n* evidence of MRI abnormality\n* psychiatric disorder\n* alcohol abuse\n* clinically significant lab abnormalities\n* residence in nursing facility\n* participation in clinical trial with experimental medication in past 1 month"}, 'identificationModule': {'nctId': 'NCT00855868', 'briefTitle': "Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals", 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': "Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals", 'orgStudyIdInfo': {'id': 'ACRIN PA 4003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['18F-AV-45', 'Amyvid', 'florbetapir'], 'description': '370 MBq (10 mCi), intravenous (IV) injection, single dose'}, {'name': '[11C]-PIB', 'type': 'DRUG', 'otherNames': ['C-11 PIB'], 'description': '555 MBq (15 mCi), IV injection, single dose \\[11C\\]-PIB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American College of Radiology Imaging Network', 'class': 'NETWORK'}, {'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}