Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-27 @ 2:52 PM
Study NCT ID:
NCT00857532
Status:
COMPLETED
Last Update Posted:
2013-03-11
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545186', 'term': 'florbetapir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaloperations@avidrp.com', 'phone': '215-298-0700', 'title': 'Chief Medical Officer', 'organization': 'Avid Radiopharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': "Subjects With Parkinson's Disease", 'description': "Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.", 'otherNumAtRisk': 31, 'otherNumAffected': 4, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Cortical Amyloid Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Normal Cognitive Performance', 'description': 'Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.'}, {'id': 'OG001', 'title': 'Subjects With Mild Cognitive Deficits', 'description': 'Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.'}, {'id': 'OG002', 'title': 'Subjects With Moderate to Severe Cognitive Impairment', 'description': 'Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.990', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '1.051', 'spread': '0.194', 'groupId': 'OG001'}, {'value': '1.146', 'spread': '0.237', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '50-60 min after injection', 'description': "Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here.", 'unitOfMeasure': 'SUVR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were enrolled in the study and received florbetapir scans.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Subjects With Parkinson's Disease", 'description': "Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections"}], 'classes': [{'title': 'Attention', 'categories': [{'measurements': [{'value': '-0.413', 'groupId': 'OG000'}]}]}, {'title': 'Initiation/Perseveration', 'categories': [{'measurements': [{'value': '-0.332', 'groupId': 'OG000'}]}]}, {'title': 'Construction', 'categories': [{'measurements': [{'value': '-0.169', 'groupId': 'OG000'}]}]}, {'title': 'Conceptualization', 'categories': [{'measurements': [{'value': '-0.206', 'groupId': 'OG000'}]}]}, {'title': 'Memory', 'categories': [{'measurements': [{'value': '-0.263', 'groupId': 'OG000'}]}]}, {'title': 'DRS-2 Total Score', 'categories': [{'measurements': [{'value': '-0.369', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Attention" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.077', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Initiation/Perseveration" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.364', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Construction" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.266', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Conceptualization" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.152', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Memory" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "DRS-2 Total" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '50-60 min after injection', 'description': "Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function.", 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who were enrolled in the study and received florbetapir scans.'}, {'type': 'SECONDARY', 'title': 'Correlation of Florbetapir SUVR With CSF Biomarker Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Subjects With Parkinson's Disease", 'description': "Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections"}], 'classes': [{'title': 'Amyloid beta', 'categories': [{'measurements': [{'value': '-0.4387', 'groupId': 'OG000'}]}]}, {'title': 'Tau', 'categories': [{'measurements': [{'value': '-0.1248', 'groupId': 'OG000'}]}]}, {'title': 'Phospho-tau', 'categories': [{'measurements': [{'value': '-0.0525', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0411', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Amyloid beta" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5800', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Tau" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8164', 'groupIds': ['OG000'], 'ciPctValue': '95', 'groupDescription': 'P-value for "Phospho-Tau" correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau.', 'statisticalMethod': "Spearman's Rank Order Correlation", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '50-60 min after injection', 'description': "Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables.", 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were a subset of all subjects enrolled in this study who were also part of an ongoing study looking at the usefulness of CSF biomarkers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Subjects With Parkinson's Disease", 'description': "Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': "Subjects With Parkinson's Disease", 'description': "Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection."}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '6.72', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2009-03-05', 'resultsFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-01', 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Cortical Amyloid Burden', 'timeFrame': '50-60 min after injection', 'description': "Standardized uptake value ratios (SUVR) were calculated and compared between subjects with PD and controls. Subjects with Parkinson's Disease (PD) were stratified into one of three groups based on performance on the age and education adjusted Mattis Dementia Rating Scale (DRS-2). The age and education adjusted DRS-2 ranges from 0 (lowest cognitive function) to 20 (highest cognitive function). SUVR is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum. SUVR values higher than 1 indicate greater amyloid burden in the predefined cortical regions as compared to cerebellum whereas scores less than 1 indicate the opposite. This outcome measure only reports data from the subjects analyzed in this study, the data from normal controls was obtained from a pre-existing database and is not reported here."}], 'secondaryOutcomes': [{'measure': 'Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.', 'timeFrame': '50-60 min after injection', 'description': "Correlation between amyloid burden (global florbetapir SUVR) and cognitive decline (DRS-2 score) was determined using Spearman's rank order correlation method where SUVR was the dependent variable and the DRS-2 score was the independent variable. This analysis was performed for total DRS-2 score and the five DRS-2 subscale scores. The subscales (score range) are: Attention (0-37), Initiation/Perseveration (0-37), Construction (0-6), Conceptualization (0-39) and Memory (0-25). The total DRS-2 score is the sum of the subscale scores and ranges from 0-144. Higher DRS-2 scores indicate greater cognitive function."}, {'measure': 'Correlation of Florbetapir SUVR With CSF Biomarker Values', 'timeFrame': '50-60 min after injection', 'description': "Correlation between amyloid burden (florbetapir SUVR) and cerebrospinal fluid (CSF) biomarker values (amyloid beta, tau and phospho-tau) was determined using Spearman's rank order correlation in a subset of subjects undergoing CSF analysis where SUVR was the dependent variable and CSF biomarker values were the independent variables."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['amyloid burden', "Parkinson's disease", 'florbetapir PET', 'amyloid PET imaging'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects may be enrolled if they (inclusion criteria):\n\n * Are males or females ≥60 years of age\n * Meet research diagnostic criteria for Parkinson's disease:\n * Diagnosis of a parkinsonian syndrome\n\n * Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions)\n * At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes\n * Supportive criteria for diagnosis of PD (two or more required)\n\n * Unilateral onset of symptoms and persistent asymmetry\n * Rest tremor present\n * Progressive illness\n * Excellent response to levodopa with dyskinesias\n * Levodopa response for 5 years or more\n * Clinical course of 10 years or more\n * Have the ability to lie flat and tolerate a 10 minute PET scan.\n\nExclusion Criteria:\n\n* Subjects may not be enrolled if any of the following are present (exclusion criteria):\n\n * History of repeated strokes, repeated head injury, definite encephalitis\n * Use of neuroleptics at onset of symptoms\n * Sustained remission\n * Strictly unilateral feature persisting \\> three years after onset\n * Significant supranuclear gaze palsy\n * Cerebellar, pyramidal and early severe autonomic findings\n * Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB)\n * Imaging study showing structural abnormality that could explain parkinsonism\n * Negative response to an adequate levodopa trial\n * Current clinically significant psychiatric disease that prohibits providing informed consent or participation in the study\n * Current clinically significant endocrine or metabolic disease, pulmonary,\n * Women of childbearing potential who are not two or more years post menopausal or surgically sterilized\n * Have received any investigational medications, or have participated in a trial with investigational medications within the last 30 days"}, 'identificationModule': {'nctId': 'NCT00857532', 'briefTitle': "Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': "A Phase 2 Trial of Florbetapir F18 PET Imaging of β-amyloid in Parkinson's Disease Patients With Cognitive Impairment", 'orgStudyIdInfo': {'id': '18F-AV-45-A12'}, 'secondaryIdInfos': [{'id': '5R43NS063607-02', 'link': 'https://reporter.nih.gov/quickSearch/5R43NS063607-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal cognitive performance', 'description': 'Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance.', 'interventionNames': ['Drug: florbetapir F 18']}, {'type': 'EXPERIMENTAL', 'label': 'Mild cognitive deficits', 'description': 'Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits.', 'interventionNames': ['Drug: florbetapir F 18']}, {'type': 'EXPERIMENTAL', 'label': 'Severe cognitive impairment', 'description': 'Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores below 5, indicating moderate to severe cognitive impairment.', 'interventionNames': ['Drug: florbetapir F 18']}], 'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['18F-AV-45', 'Amyvid', 'florbetapir'], 'description': '10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection', 'armGroupLabels': ['Mild cognitive deficits', 'Normal cognitive performance', 'Severe cognitive impairment']}]}, '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': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}