Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-08 @ 7:24 PM
Study NCT ID:
NCT02989402
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2016-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068836', 'term': 'Rivastigmine'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 16, 'seriousNumAtRisk': 100, 'deathsNumAffected': 2, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'SKIN IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'CEREBRAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'CEREBROSPINAL FLUID LEAKAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'DEMENTIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'HYPONATRAEMIC SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'PNEUMONIA ASPIRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'title': 'At least one AE', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'AEs related to study treatment', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'At least one SAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.', 'description': 'Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini-Mental State Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '4.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': 'The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); and results in a total score can range from 0 to 30, with higher scores indicating better function.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '10.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': "Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Compliance by Caregiver Medication Questionnaire (CMQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '2.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16', 'description': 'Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = "never took the medication as prescribed" to 10 = "always took the medication as prescribed."', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Skin Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Score 3 to 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The following score system were used to assess skin irritation:\n\nI. Dermal response:\n\nScore 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Urinary Tract Infection (UTI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Urine samples were collected to assess the number of patients with UTI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.'}, {'type': 'SECONDARY', 'title': 'Patch Adhesion to the Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Score 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score.\n\nFollowing scores were used to capture comments relating to patch adhesion:\n\n0 = 90 % adhered (essentially no lift off of the skin)\n\n1. = 75% to \\< 90% adhered (some edges only lifting off of the skin)\n2. = 50% to \\< 75% adhered (less than half of the patch lifting off the skin)\n3. = \\< 50% adhered but not detached (more than half the system lifting off of the skin without falling off)\n4. = the patch was completely detached. The score ranges from 1 to 4 where a higher score indicates less adhesion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse event, or serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Discontinuation of study treatment and premature patient withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Patient no longer on monotherapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Patient stopped Exelon® patch treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in 9 investigative sites in India.', 'preAssignmentDetails': 'Participants who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivastigmine Patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.3', 'spread': '9.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-21', 'size': 770610, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-08T05:49', 'hasProtocol': True}, {'date': '2022-12-01', 'size': 3911804, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-08T05:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2016-12-08', 'resultsFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-08', 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.', 'description': 'Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline, 16 weeks', 'description': 'The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); and results in a total score can range from 0 to 30, with higher scores indicating better function.'}, {'measure': "Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score", 'timeFrame': 'Baseline, 16 weeks', 'description': "Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence."}, {'measure': 'Compliance by Caregiver Medication Questionnaire (CMQ) Score', 'timeFrame': 'Week 16', 'description': 'Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = "never took the medication as prescribed" to 10 = "always took the medication as prescribed."'}, {'measure': 'Number of Participants With a Skin Irritation', 'timeFrame': 'Week 16', 'description': 'The following score system were used to assess skin irritation:\n\nI. Dermal response:\n\nScore 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters'}, {'measure': 'Number of Participants With a Urinary Tract Infection (UTI)', 'timeFrame': '16 weeks', 'description': 'Urine samples were collected to assess the number of patients with UTI.'}, {'measure': 'Patch Adhesion to the Skin', 'timeFrame': 'Week 16', 'description': 'Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score.\n\nFollowing scores were used to capture comments relating to patch adhesion:\n\n0 = 90 % adhered (essentially no lift off of the skin)\n\n1. = 75% to \\< 90% adhered (some edges only lifting off of the skin)\n2. = 50% to \\< 75% adhered (less than half of the patch lifting off the skin)\n3. = \\< 50% adhered but not detached (more than half the system lifting off of the skin without falling off)\n4. = the patch was completely detached. The score ranges from 1 to 4 where a higher score indicates less adhesion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer, Rivastigmine'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm\\^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.", 'detailedDescription': "This was a multicenter, prospective, single-arm, open-label, phase IV study to evaluate safety, tolerability and effectiveness of Rivastigmine 27 mg -15 cm\\^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. The prescription decision was independent of the decision for inclusion in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients willing to participate in the study by providing written informed consent.\n2. Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3 .Patient's prescribed with rivastigmine 27mg -15 cm\\^2 transdermal patch as per discretion of treating physician\n\nExclusion Criteria:\n\n1. Contraindication as per PI\n2. Patients simultaneously participating in other studies\n3. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)\\], whichever is longer.\n4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes"}, 'identificationModule': {'nctId': 'NCT02989402', 'briefTitle': "A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch", 'orgStudyIdInfo': {'id': 'CENA713DIN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivastigmine patch', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day', 'interventionNames': ['Drug: Rivastigmine']}], 'interventions': [{'name': 'Rivastigmine', 'type': 'DRUG', 'description': '15 cm\\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day', 'armGroupLabels': ['Rivastigmine patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560 055', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560052', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560052', 'city': 'Banglaore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site'}, {'zip': '560005', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400 053', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '700017', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700054', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}