{ "FullStudy":{ "Rank":217670, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518374", "OrgStudyIdInfo":{ "OrgStudyId":"18F-AV-45-A14" }, "Organization":{ "OrgFullName":"Avid Radiopharmaceuticals", "OrgClass":"INDUSTRY" }, "BriefTitle":"Clinical Evaluation of Florbetapir F 18 (18F-AV-45)", "OfficialTitle":"Clinical Evaluation of Florbetapir F 18 (18F-AV-45)" }, "StatusModule":{ "StatusVerifiedDate":"June 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2009" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 3, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 3, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"July 20, 2011", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 16, 2018", "ResultsFirstSubmitQCDate":"May 16, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 14, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"June 22, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 18, 2018", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Avid Radiopharmaceuticals", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This protocol is designed to standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden in subjects participating in other studies (companion protocol) such as longitudinal studies of aging and studies of biomarkers for neurodegenerative diseases." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Alzheimer Disease", "Mild Cognitive Impairment", "Neurodegenerative Diseases" ] }, "KeywordList":{ "Keyword":[ "Male or female subjects at least 18 years of age", "AD", "MCI" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"1768", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Florbetapir-PET Scans", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Florbetapir F 18" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Florbetapir F 18", "InterventionDescription":"370 MBq (10 mCi)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Florbetapir-PET Scans" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "18F-AV-45", "Amyvid", "florbetapir" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration", "PrimaryOutcomeDescription":"Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported.\n\n(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in \"Adverse Events\" section below)", "PrimaryOutcomeTimeFrame":"48 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Subjects who meet all of the following criteria are eligible to enroll in this study:\n\nMale or female subjects at least 18 years of age;\nSubjects who sign an IRB approved informed consent prior to any study procedures. Where subjects are deemed incapable of informed consent, a legally authorized representative may provide consent, with the subject's documented assent; and\nSubjects who in the opinion of the investigator can tolerate the PET scan procedures.\n\nSubjects will be excluded from enrollment if they:\n\nHave clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject;\n\nHave current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following:\n\ncardiac surgery or myocardial infarction within the last 4 weeks;\nunstable angina;\nacute decompensated congestive heart failure or class IV heart failure;\ncurrent significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope, or near syncope;\nuncontrolled high blood pressure; or\nQTc > 450 msec (by history or for patients with cardiac disease by screening evaluation in companion study)\n\nBefore enrolling a patient with any of the above conditions, the investigator must have performed a cardiac evaluation and obtain permission from the sponsor.\n\nHave a history of drug or alcohol abuse within the last year, or prior prolonged history of abuse;\nWomen of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging) or breastfeeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods for 24 hours following administration of Florbetapir F 18 Injection ( such as oral contraceptives for at least three months or an IUD for at least two months prior to the start of the screening visit, or various barrier methods, e.g., diaphragm or combination condom and spermicide);\nHave a history of relevant severe drug allergy or hypersensitivity (Relevant severe drug allergies should be determined by the PI, and any questions about a subject's eligibility can be directed to Avid. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study);\nAre patients who have received an investigational medication under an FDA IND protocol within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. Patients who have ever participated in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be enrolled without prior sponsor approval unless it can be demonstrated that the patient received only placebo in the course of the trial;\nAre patients with current clinically significant unstable medical comorbidities, as indicated by history or physical exam, that pose a potential safety risk to the subject.\nAre patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study. If another radiotracer is required in the companion protocol, patients may be able to receive a radiopharmaceutical for imaging or therapy within the 24 hours prior to the imaging session with prior sponsor approval and at the discretion of the investigator.; and\nAre patients who, in the opinion of the investigator, are otherwise unsuitable for a study of this type.\n\nIf at the time of enrollment subjects do not meet all eligibility criteria, the subjects may still be enrolled if documentation is provided demonstrating that the subject will meet all criteria at the time of the first imaging procedure.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Chief Medical Officer", "OverallOfficialAffiliation":"Avid Radiopharmaceuticals", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Banner Health", "LocationCity":"Phoenix", "LocationState":"Arizona", "LocationZip":"85006", "LocationCountry":"United States" },{ "LocationFacility":"Banner Sun Health Research Institute", "LocationCity":"Sun City", "LocationState":"Arizona", "LocationZip":"85351", "LocationCountry":"United States" },{ "LocationFacility":"UC Davis", "LocationCity":"Davis", "LocationState":"California", "LocationZip":"95618", "LocationCountry":"United States" },{ "LocationFacility":"UC Irvine", "LocationCity":"Irvine", "LocationState":"California", "LocationZip":"92697", "LocationCountry":"United States" },{ "LocationFacility":"University of Southern California", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90033", "LocationCountry":"United States" },{ "LocationFacility":"UC Irvine", "LocationCity":"Orange", "LocationState":"California", "LocationZip":"92868", "LocationCountry":"United States" },{ "LocationFacility":"UC San Francisco", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94121", "LocationCountry":"United States" },{ "LocationFacility":"UC San Francisco Memory Center", "LocationCity":"San Francisco", "LocationState":"California", "LocationZip":"94143", "LocationCountry":"United States" },{ "LocationFacility":"Mayo Clinic Jacksonville", "LocationCity":"Jacksonville", "LocationState":"Florida", "LocationZip":"32254", "LocationCountry":"United States" },{ "LocationFacility":"Mt. Sinai Medical Center", "LocationCity":"Miami Beach", "LocationState":"Florida", "LocationZip":"33140", "LocationCountry":"United States" },{ "LocationFacility":"Northwestern University", "LocationCity":"Chicago", "LocationState":"Illinois", "LocationZip":"60611", "LocationCountry":"United States" },{ "LocationFacility":"University of Kansas", "LocationCity":"Kansas City", "LocationState":"Kansas", "LocationZip":"66160", "LocationCountry":"United States" },{ "LocationFacility":"Johns Hopkins University", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21287", "LocationCountry":"United States" },{ "LocationFacility":"Massachusetts General Hospital", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02114", "LocationCountry":"United States" },{ "LocationFacility":"University of Mississippi Medical Center", "LocationCity":"Jackson", "LocationState":"Mississippi", "LocationZip":"39216", "LocationCountry":"United States" },{ "LocationFacility":"Washington University School of Medicine", "LocationCity":"Saint Louis", "LocationState":"Missouri", "LocationZip":"63110", "LocationCountry":"United States" },{ "LocationFacility":"Duke University", "LocationCity":"Durham", "LocationState":"North Carolina", "LocationZip":"27710", "LocationCountry":"United States" },{ "LocationFacility":"Wake Forest University", "LocationCity":"Winston-Salem", "LocationState":"North Carolina", "LocationZip":"27104", "LocationCountry":"United States" },{ "LocationFacility":"Jefferson", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19107", "LocationCountry":"United States" },{ "LocationFacility":"University of Pennsylvania", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19107", "LocationCountry":"United States" },{ "LocationFacility":"Butler Hospital", "LocationCity":"Providence", "LocationState":"Rhode Island", "LocationZip":"02906", "LocationCountry":"United States" },{ "LocationFacility":"University of Tennessee", "LocationCity":"Knoxville", "LocationState":"Tennessee", "LocationZip":"37920", "LocationCountry":"United States" },{ "LocationFacility":"Vanderbilt", "LocationCity":"Nashville", "LocationState":"Tennessee", "LocationZip":"37232", "LocationCountry":"United States" },{ "LocationFacility":"UTSW", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75231", "LocationCountry":"United States" },{ "LocationFacility":"UTSW", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75235", "LocationCountry":"United States" },{ "LocationFacility":"UTSW", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"This was a standardized imaging protocol designed to support companion studies where amyloid imaging was used as a biomarker in longitudinal studies of aging or studies of biomarkers for neurodegenerative diseases. Subjects had to meet additional inclusion/exclusion criteria for the companion protocol before being injected and imaged under A14.", "FlowRecruitmentDetails":"All enrolled subjects who received an injection of florbetapir and completed safety assessment were considered to have completed the study.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Florbetapir-PET Scans", "FlowGroupDescription":"Florbetapir F 18: 370 MBq (10 mCi)" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1768" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1761" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Florbetapir-PET Scans", "BaselineGroupDescription":"Florbetapir F 18: 370 MBq (10 mCi)" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"1768" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasurePopulationDescription":"6 participants did not have baseline age in the database", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"1762" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"68.3", "BaselineMeasurementSpread":"13.43" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"1768" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"920" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"848" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"1768" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"28" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"233" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1487" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"1768" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1768" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration", "OutcomeMeasureDescription":"Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported.\n\n(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in \"Adverse Events\" section below)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"48 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Florbetapir-PET Scans", "OutcomeGroupDescription":"Florbetapir F 18: 370 MBq (10 mCi)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"1768" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Headache", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21" } ] } } ] } },{ "OutcomeClassTitle":"Injection site pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Dizziness", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Nausea", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Fatigue", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Back pain", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Dry mouth", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0.4", "EventsTimeFrame":"Within 48 hours of florbetapir injection", "EventsDescription":"Note: adverse events results differ from results reported above because this section reports ALL adverse events, regardless of relatedness designation by the investigator.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Florbetapir-PET Scans", "EventGroupDescription":"Florbetapir F 18: 370 MBq (10 mCi)", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"1768", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"1768", "EventGroupOtherNumAffected":"111", "EventGroupOtherNumAtRisk":"1768" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Ischaemic stroke", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventSourceVocabulary":"MedDRA (17.1)", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"1768" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"47", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"14", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"12", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Dizziness", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Back pain", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Injection site pain", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"1768" } ] } },{ "OtherEventTerm":"Dry mouth", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA (17.1)", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"1768" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Chief Medical Officer", "PointOfContactOrganization":"Avid Radiopharmaceuticals, Inc.", "PointOfContactEMail":"clinicaloperations@avidrp.com", "PointOfContactPhone":"215-298-0700" } } }, "DocumentSection":{ "LargeDocumentModule":{ "LargeDocList":{ "LargeDoc":[ { "LargeDocTypeAbbrev":"Prot", "LargeDocHasProtocol":"Yes", "LargeDocHasSAP":"No", "LargeDocHasICF":"No", "LargeDocLabel":"Study Protocol", "LargeDocDate":"February 4, 2013", "LargeDocUploadDate":"05/15/2018 15:50", "LargeDocFilename":"Prot_000.pdf" },{ "LargeDocTypeAbbrev":"SAP", "LargeDocHasProtocol":"No", "LargeDocHasSAP":"Yes", "LargeDocHasICF":"No", "LargeDocLabel":"Statistical Analysis Plan", "LargeDocDate":"May 9, 2018", "LargeDocUploadDate":"05/15/2018 15:51", "LargeDocFilename":"SAP_001.pdf" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000000544", "ConditionMeshTerm":"Alzheimer Disease" },{ "ConditionMeshId":"D000019636", "ConditionMeshTerm":"Neurodegenerative Diseases" },{ "ConditionMeshId":"D000060825", "ConditionMeshTerm":"Cognitive Dysfunction" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000003704", "ConditionAncestorTerm":"Dementia" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000024801", "ConditionAncestorTerm":"Tauopathies" },{ "ConditionAncestorId":"D000019965", "ConditionAncestorTerm":"Neurocognitive Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" },{ "ConditionAncestorId":"D000003072", "ConditionAncestorTerm":"Cognition Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M28292", "ConditionBrowseLeafName":"Cognitive Dysfunction", "ConditionBrowseLeafAsFound":"Mild Cognitive Impairment", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2466", "ConditionBrowseLeafName":"Alzheimer Disease", "ConditionBrowseLeafAsFound":"Alzheimer's Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20142", "ConditionBrowseLeafName":"Neurodegenerative Diseases", "ConditionBrowseLeafAsFound":"Neurodegenerative Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5487", "ConditionBrowseLeafName":"Dementia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21586", "ConditionBrowseLeafName":"Tauopathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20420", "ConditionBrowseLeafName":"Neurocognitive Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4884", "ConditionBrowseLeafName":"Cognition Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T2204", "ConditionBrowseLeafName":"Familial Alzheimer Disease", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }