Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 12:17 PM
Study NCT ID:
NCT01972204
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2013-10-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intensive Instruction on the Use of Aricept
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'machida@mirai-iryo.com', 'phone': '81-3-3263-4801', 'title': 'Tomoko Machida (Director)', 'organization': 'Mirai Iryo Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 20, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 14, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Medication Continuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Number of Participants who Continue the Medication for 48 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reasons for Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}], 'classes': [{'categories': [{'title': "Pysician's decision", 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': "Participant's wish", 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': "Caretaker's wish", 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Reasons for discontinuation of the Medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 12, 24, 48', 'description': 'Adverse Events for each arm', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'FG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive Adherence Instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure\n\nIntensive adherence instruction: Instruction with educational brochure'}, {'id': 'BG001', 'title': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.\n\nControl: Instruction as per usual practice'}, {'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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.7', 'spread': '7.23', 'groupId': 'BG000'}, {'value': '80.2', 'spread': '6.99', 'groupId': 'BG001'}, {'value': '79.9', 'spread': '7.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Treatmnent for alzheimer's disease before study", 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-09-05', 'size': 613550, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-17T20:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-17', 'studyFirstSubmitDate': '2013-10-24', 'resultsFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2013-10-24', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-17', 'studyFirstPostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Medication Continuation', 'timeFrame': '48 weeks', 'description': 'Number of Participants who Continue the Medication for 48 weeks'}], 'secondaryOutcomes': [{'measure': 'Reasons for Discontinuation', 'timeFrame': '48 weeks', 'description': 'Reasons for discontinuation of the Medication'}, {'measure': 'Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics', 'timeFrame': '48 weeks', 'description': 'Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics'}, {'measure': 'Adverse Events', 'timeFrame': 'Week 2, 12, 24, 48', 'description': 'Adverse Events for each arm'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Type Dementia"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.', 'detailedDescription': 'To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV.\n* Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.\n* Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.\n* Outpatients in their own home.\n\nExclusion Criteria:\n\n* Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment.\n* Known hypersensitivity to donepezil or piperidine derivatives.\n* Involvement in any other investigational drug clinical trail during the preceding 12 weeks."}, 'identificationModule': {'nctId': 'NCT01972204', 'briefTitle': 'Intensive Instruction on the Use of Aricept', 'organization': {'class': 'OTHER', 'fullName': 'Mirai Iryo Research Center, Inc.'}, 'officialTitle': "A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'ART-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive adherence instruction', 'description': 'Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure', 'interventionNames': ['Behavioral: Intensive adherence instruction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Intensive adherence instruction', 'type': 'BEHAVIORAL', 'description': 'Instruction with educational brochure', 'armGroupLabels': ['Intensive adherence instruction']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Instruction as per usual practice', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Fujisawa Tokushukai Hospital', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}], 'overallOfficials': [{'name': 'Tetsumasa Kamei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shonan Fujisawa Tokushukai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirai Iryo Research Center, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital Director', 'investigatorFullName': 'Tetsumasa Kamei', 'investigatorAffiliation': 'Mirai Iryo Research Center, Inc.'}}}}