Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 4:41 PM
Study NCT ID:
NCT00912808
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease
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': 'D000077265', 'term': 'Donepezil'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chungka@ohsu.edu', 'phone': '503 220 8262', 'title': 'Kathryn Chung, MD', 'phoneExt': '51091', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small number of subjects and lack of objective measurement to quantify falls. The most difficult condition to exclude was co-existing freezing of gait.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Donepezil Then Placebo', 'description': 'Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Then Donepezil', 'description': 'Sugar pill 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then 3 weeks washout then Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fall Frequency Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': 'Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received Placebo tablet (matching Donepezil) each morning in either the first or last 6 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.', 'unitOfMeasure': 'Number Falls/Day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Near Falls Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': 'Participants who received Donepezil tablet (matching 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received Placebo tablet (matching Donepezil 5 mg for the first 3 weeks then 10 mg for the next 3 weeks) each morning in either the first or last 6 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '2.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.', 'unitOfMeasure': 'Number Near Falls/Day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)', 'description': 'Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16'}, {'id': 'FG001', 'title': 'Placebo (6 Weeks), Washout (3 Weeks), Donepezil (6 Weeks)', 'description': 'Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Received Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult subjects were those diagnosed with probable idiopathic PD, defined as manifesting two of three cardinal features (tremor, rigidity, bradykinesia), without any other historical or physical signs to suggest another diagnosis, and were recruited from the Oregon Health and Science University (OHSU) Movement Disorders clinic.', 'preAssignmentDetails': 'This is a cross-over treatment trial. Each drug phase, donepezil or identical placebo, lasted 6 weeks, with a three week washout period in between. In each drug phase, subjects were instructed to take one tablet (mg of donepezil or placebo) for three weeks and to increase to two tablets (10 mg) for the remaining three weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Donepezil (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)', 'description': 'Donepezil 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Placebo (sugar pill) 5 mg qam weeks 10-13, 10 mg qam weeks 14-16'}, {'id': 'BG001', 'title': 'Placebo (6 Weeks), Washout (3 Weeks), Placebo (6 Weeks)', 'description': 'Placebo (sugar pill) 5 mg qam weeks 1-3, 10 mg qam weeks 3-6 then Nothing weeks 7-9 then Donepezil 5 mg qam weeks 10-13, 10 mg qam weeks 14-16'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '10.2', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '23 participants were enrolled into the study. 3 participants screen failed.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2009-06-02', 'resultsFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-20', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fall Frequency Per Day', 'timeFrame': '6 weeks', 'description': 'The primary outcomes were fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Falls were defined as landing on the floor. Fall frequency is the number of reported falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Near Falls Per Day', 'timeFrame': '6 weeks', 'description': 'The secondary outcome was near fall frequency determined using daily event recording by the subjects onto postcards which accumulated data for six weeks per phase. Near falls were defined as a fall that did not land on the floor (for example grabbing a handrail or a table). Near fall frequency is the number of reported near falls divided by the number of days reported. Postcards were mailed back to the investigator weekly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['parkinsons disease', 'falling'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment.", 'detailedDescription': "This trial is a double-blinded cross-over design comparing donepezil with placebo in 40 subjects with idiopathic Parkinson's disease who report frequent falls or near falls (\\>2/week). The purpose of this study is to find out if a medication that increases levels of a brain chemical called acetylcholine will improve balance and reduce falls in patients with parkinson's disease who have the problem of very poor balance and are frequently falling or nearly falling on a daily basis. Donepezil, a drug approved for the treatment of Alzheimer's dementia, will reduce falls in subjects with Parkinson's disease and balance impairment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age over 21\n* Diagnosis of Parkinson's disease\n* Treated with dopaminergic medication for at least 1 year\n\nExclusion Criteria:\n\n* Must be ambulatory (can use walker or cane)\n* No obvious remediable cause of falls\n* Falls are on basis of non-CNS etiologies (cardiogenic, orthopedic, peripheral neuropathy, etc)\n* Dementia present (MMSE \\< 25)\n* Not taking cholinergic or anticholinergic medications 10 days prior to screening visit\n* No Warfarin use"}, 'identificationModule': {'nctId': 'NCT00912808', 'briefTitle': "Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': "A Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's", 'orgStudyIdInfo': {'id': 'e1784'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donepezil', 'interventionNames': ['Drug: Donepezil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'interventionNames': ['Drug: Sugar Pill (placebo)']}], 'interventions': [{'name': 'Donepezil', 'type': 'DRUG', 'otherNames': ['aricept'], 'description': 'donepezil, 5 mg, capsule, once a day, 3 weeks', 'armGroupLabels': ['Donepezil']}, {'name': 'Sugar Pill (placebo)', 'type': 'DRUG', 'description': 'sugar pill, one capsule, once a day, 3 weeks', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathryn Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Neurology', 'investigatorFullName': 'Kathryn Anne Chung', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}