{ "FullStudy":{ "Rank":217601, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519271", "OrgStudyIdInfo":{ "OrgStudyId":"813803" }, "Organization":{ "OrgFullName":"University of Pennsylvania", "OrgClass":"OTHER" }, "BriefTitle":"Mild Cognitive Impairment in Parkinson's Disease", "OfficialTitle":"A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease" }, "StatusModule":{ "StatusVerifiedDate":"February 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 24, 2016", "ResultsFirstSubmitQCDate":"February 22, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 7, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"February 22, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 7, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University of Pennsylvania", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.\n\nDespite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.", "DetailedDescription":"This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.\n\nPhase I\n\nScreening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.\n\nVisit 1 - Baseline Visit, Start Study Medication\n\nPhone Call 1 - Check in to see how you are feeling after starting the study medication\n\nVisit 2 - 4 Weeks after Baseline, Increase Study Medication if tolerated\n\nPhone Call 2 - Check in to see how you are feeling after increasing the study medication\n\nVisit 3/ Phase I Termination Visit - 10 Weeks after Baseline (Phase I Termination Visit)\n\n4 Week Break (no study medication)\n\nPhase II\n\nVisit 4/ Phase II Baseline - 14 Weeks after Baseline, Start Study Medication\n\nPhone Call 3 - Check in to see how you are feeling after starting the study medication\n\nVisit 5 - 18 Weeks after Baseline, Increase Study Medication\n\nPhone Call 4 - Check in to see how you are feeling after increasing the study medication\n\nVisit 6/Phase II and Study Termination Visit - 24 Weeks after Baseline\n\nVisits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.\n\nAfter 24 weeks, your study participation will be over." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Parkinson's Disease", "Mild Cognitive Impairment" ] }, "KeywordList":{ "Keyword":[ "Parkinson's Disease", "Mild Cognitive Impairment", "Cognition", "Memory", "Attention", "Exelon", "Rivastigmine" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"28", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo Patch", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo Patches" ] } },{ "ArmGroupLabel":"Exelon Patch (rivastigmine transdermal system)", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Exelon Patch (rivastigmine transdermal system)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Exelon Patch (rivastigmine transdermal system)", "InterventionDescription":"The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Exelon Patch (rivastigmine transdermal system)" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo Patches", "InterventionDescription":"The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo Patch" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)", "PrimaryOutcomeDescription":"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.\n\nThe scale rates total improvement on a 7 point scale:\n\n= Very much improved\n= Much improved\n= Minimally improved\n= No change\n= Minimally worse\n= Much worse\n= Very much worse\n\nA participant scoring a 1 or 2 is considered a responder on the CGI scale.", "PrimaryOutcomeTimeFrame":"The ADCS-CGIC will be administered at the end of each study phase." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Montreal Cognitive Assessment (MoCA)", "SecondaryOutcomeDescription":"The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.", "SecondaryOutcomeTimeFrame":"The MoCA was administered in the beginning and end of each study phase." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParticipants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.\nParticipants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).\nParticipants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.\n\nExclusion Criteria:\n\nActive suicide ideation.\nWeighing less than 100 lbs (45 kgs).\nHistory of Deep Brain Stimulation surgery.\nDiagnosis of Dementia\nTaking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.\nFemales that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"85 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Daniel Weintraub, MD", "OverallOfficialAffiliation":"University of Pennsylvania", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Pennsylvania, Ralston House", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19104", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Published Study Abstract", "SeeAlsoLinkURL":"https://www.ncbi.nlm.nih.gov/pubmed/25914281" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)", "FlowRecruitmentDetails":"Potential participants were a convenience sample of PD patients primarily from the Parkinson’s Disease and Movement Disorders Center at the University of Pennsylvania. Patients between the ages of 40 and 85 y with idiopathic PD for more than 2 years and reporting cognitive were screened for study participation.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Placebo First Then Rivastigmine", "FlowGroupDescription":"Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.\n\nExelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )\n\nPlacebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Rivastigmine First Then Placebo", "FlowGroupDescription":"5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.\n\nExelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )\n\nPlacebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Phase 1", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"1 participant discontinued participation in the middle of phase 1.", "FlowAchievementNumSubjects":"13" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" } ] } } ] } },{ "FlowPeriodTitle":"Phase 2", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"2 participants discontinued after Phase 1", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Placebo Patch First Then 5-10cm2 Rivastigmine Patch", "BaselineGroupDescription":"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).\n\nExelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )\n\nEach phase lasted 10 weeks." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"5-10cm2 Rivastigmine Patch First First Then Placebo Patch", "BaselineGroupDescription":"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )\n\nPlacebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).\n\nEach phase lasted 10 weeks." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"28" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"66.1", "BaselineMeasurementSpread":"5.5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62.6", "BaselineMeasurementSpread":"10.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"64.3", "BaselineMeasurementSpread":"8.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"22" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)", "OutcomeMeasureDescription":"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.\n\nThe scale rates total improvement on a 7 point scale:\n\n= Very much improved\n= Much improved\n= Minimally improved\n= No change\n= Minimally worse\n= Much worse\n= Very much worse\n\nA participant scoring a 1 or 2 is considered a responder on the CGI scale.", "OutcomeMeasurePopulationDescription":"Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"scores on the CGIC", "OutcomeMeasureTimeFrame":"The ADCS-CGIC will be administered at the end of each study phase.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo Patch", "OutcomeGroupDescription":"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Exelon Patch (Rivastigmine Transdermal System)", "OutcomeGroupDescription":"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"26" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"28" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.92", "OutcomeMeasurementSpread":"0.94" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.48", "OutcomeMeasurementSpread":"0.89" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Montreal Cognitive Assessment (MoCA)", "OutcomeMeasureDescription":"The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.", "OutcomeMeasurePopulationDescription":"Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Score on MoCA", "OutcomeMeasureTimeFrame":"The MoCA was administered in the beginning and end of each study phase.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Placebo", "OutcomeGroupDescription":"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Rivastigmine", "OutcomeGroupDescription":"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"23" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25.08", "OutcomeMeasurementSpread":"2.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24.93", "OutcomeMeasurementSpread":"2.5" } ] } } ] } },{ "OutcomeClassTitle":"Week 16", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"24.73", "OutcomeMeasurementSpread":"3.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"25.6", "OutcomeMeasurementSpread":"2.7" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisNonInferiorityType":"Superiority", "OutcomeAnalysisParamType":"Cohen's D", "OutcomeAnalysisParamValue":".35", "OutcomeAnalysisCINumSides":"2-Sided" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events were recorded at every study visit post baseline (Phase 1: Week 4 and Week 10; Phase 2: Week 14, Week 18 and Week 24).", "EventsDescription":"We used a modified version of the Treatment Emergent Symptom Scale (TESS) to assess psychiatric, cognitive, and motor adverse effects.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Placebo Patch", "EventGroupDescription":"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"9", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG001", "EventGroupTitle":"Exelon Patch (Rivastigmine Transdermal System)", "EventGroupDescription":"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.\n\n5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"28", "EventGroupOtherNumAffected":"11", "EventGroupOtherNumAtRisk":"28" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Increased Blood Pressure", "OtherEventOrganSystem":"Vascular disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"8", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Pain", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Rash", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Other", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Tremor", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Decreased Blood Pressure", "OtherEventOrganSystem":"Vascular disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Fatigue", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Insomnia", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Worse Balance", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Visual Hallucinations", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Increased \"off\" time", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Weight Loss", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Cognitive Impairment", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" } ] } },{ "OtherEventTerm":"Depression", "OtherEventOrganSystem":"General disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"28" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Daniel Weintraub, MD", "PointOfContactOrganization":"University of Pennsylvania", "PointOfContactEMail":"Daniel.Weintraub@UPHS.UPENN.EDU", "PointOfContactPhone":"215-349-8207" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000068836", "InterventionMeshTerm":"Rivastigmine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { 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