Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-25 @ 4:45 PM
Study NCT ID:
NCT00305903
Status:
COMPLETED
Last Update Posted:
2007-12-21
First Post:
2006-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}, {'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-17', 'studyFirstSubmitDate': '2006-03-20', 'studyFirstSubmitQcDate': '2006-03-20', 'lastUpdatePostDateStruct': {'date': '2007-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)'}], 'secondaryOutcomes': [{'measure': 'Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy'}]}, 'conditionsModule': {'keywords': ['Dementia,', "Alzheimer's,", 'Rivastigmine,', 'Memantine'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '21274364', 'type': 'DERIVED', 'citation': "Sadowsky CH, Dengiz A, Meng X, Olin JT; US38 Study Group. Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00852. doi: 10.4088/PCC.09m00852oli."}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of probable Alzheimer's disease;\n* Have an MMSE score between 10 and 20;\n* Must be able to swallow capsule/tablet;\n* Must have a caregiver who is able to attend all study visits;\n\nExclusion Criteria:\n\n* Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;\n* Have a current diagnosis of active, uncontrolled seizure disorder;\n* Have a history within the past year or current diagnosis of cerebrovascular disease\n* Have a current diagnosis of severe or unstable cardiovascular disease;\n* Had a myocardial infarction (MI) within the last six months;\n* Have specific respiratory, digestive, renal, or endocrine disorders;\n* Have had previous treatment with rivastigmine or memantine;\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00305903', 'briefTitle': "Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)", 'orgStudyIdInfo': {'id': 'CENA713BUS32'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rivastigmine, memantine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08759', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': '862-778-8300'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}