Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 2:37 PM
Study NCT ID:
NCT01025466
Status:
COMPLETED
Last Update Posted:
2010-05-19
First Post:
2009-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exelon Patch and Combination With Memantine Comparative Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-18', 'studyFirstSubmitDate': '2009-12-02', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention rate at week 16 after randomization', 'timeFrame': 'End point (16 weeks after randomization)'}], 'secondaryOutcomes': [{'measure': "Change from baseline at week 16 in Alzheimer's Disease Assessment Scale-Cognitive subscale", 'timeFrame': '16 weeks after randomization'}, {'measure': 'Change from baseline at week 16 in Mini-Mental State Examination', 'timeFrame': '16 weeks after randomization'}, {'measure': 'Change from baseline at week 16 in Frontal Assessment Battery', 'timeFrame': '16 weeks after randomization'}, {'measure': "Change from baseline at week 16 in Alzheimer's Disease Cooperative Study - Activities of Daily Living", 'timeFrame': '16 weeks after randomization'}, {'measure': 'Change from baseline at week 16 in Caregiver-Administered Neuropsychiatric Inventory', 'timeFrame': '16 weeks after randomization'}, {'measure': 'Change from baseline at week 16 in Cohen Mansfield Agitation Inventory', 'timeFrame': '16 weeks after randomization'}, {'measure': 'Change from baseline at week 16 in Clinical Dementia Rating Scale-Sum of Boxes', 'timeFrame': '16 weeks after randomization'}, {'measure': 'Safety', 'timeFrame': 'from baseline to end-point'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '21561398', 'type': 'DERIVED', 'citation': "Choi SH, Park KW, Na DL, Han HJ, Kim EJ, Shim YS, Lee JH; Expect Study Group. Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer's disease: a multicenter, randomized, open-label, parallel-group study. Curr Med Res Opin. 2011 Jul;27(7):1375-83. doi: 10.1185/03007995.2011.582484. Epub 2011 May 12."}]}, 'descriptionModule': {'briefSummary': "The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary objective is to compare the efficacy and safety between rivastigmine patch monotherapy and combination therapy with memantine in patients with AD. The study hypothesis is that the tolerability of the combination therapy with memantine is not inferior to that of rivastigmine patch monotherapy in AD patients.", 'detailedDescription': 'Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. We hypothesized that combination of memantine and rivastigmine patch will be safe and well tolerated and result in more clinical benefit in patients with AD in comparison with rivastigmine patch monotherapy, for the mechanisms of the drugs are different.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Dementia by DSM-IV and probable AD by NINCDS-ADRDA\n* Age of 50 to 90 years\n* Mini-Mental State Examination (MMSE) score of 10 to 20\n* Brain MRI or CT scan consistent with a diagnosis of probable AD\n* The caregiver must meet the patient at least once a week and be sufficiently familiar with the patient to provide accurate data.\n* Ambulatory or ambulatory-aided (is, walker or cane) ability\n* Written informed consent will be obtained from the patient (if possible) and from the patient's legally acceptable representative. Even if unable to provide written informed consent, the patient must assent verbally to participating in the study.\n\nExclusion Criteria:\n\n* Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disease, active peptic ulcer disease, severe hepatic or renal disease, or any medical condition which would prohibit them from completing the study\n* Any psychiatric or primary neurodegenerative disorder other than AD\n* Any patients with hearing or visual problem that can disturb the efficient evaluation of the patients.\n* Any patients with a history of drug addiction or alcohol addiction for the past 10 years\n* Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second ot third degree A-V blocks\n* Clinically significant laboratory abnormalities to affect cognitive function (i.e.abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or syphilis, etc)\n* History of allergy to topical products containing any of the constitution of the patches\n* Current diagnosis of an active skin lesion\n* Involved in other clinical trials or treated by experimental drug within 4 weeks\n* Patients with hypersensitivity to cholinesterase inhibitors"}, 'identificationModule': {'nctId': 'NCT01025466', 'acronym': 'EXPECT', 'briefTitle': 'Exelon Patch and Combination With Memantine Comparative Trial', 'organization': {'class': 'OTHER', 'fullName': 'Inha University Hospital'}, 'officialTitle': "A Multicenter, Randomized, Open-label Study to Compare the Tolerability Between Rivastigmine Patch Monotherapy and Combination Therapy With Memantine in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'EXPECT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rivastigmine patch monotherapy', 'interventionNames': ['Drug: Rivastigmine transdermal patch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination therapy with memantine', 'interventionNames': ['Drug: Rivastigmine transdermal patch (Exelon patch), memantine']}], 'interventions': [{'name': 'Rivastigmine transdermal patch (Exelon patch), memantine', 'type': 'DRUG', 'otherNames': ['exelon patch, ebixa'], 'description': 'All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.', 'armGroupLabels': ['Combination therapy with memantine']}, {'name': 'Rivastigmine transdermal patch', 'type': 'DRUG', 'otherNames': ['exelon patch'], 'description': 'All patients start on a 5-cm2 rivastigmine patch and their dose is increased to a 10-cm2 patch after 4 weeks. Patients will be randomly allocated to 1 of 2 treatment groups of rivastigmine patch monotherapy and combination therapy with memantine at the baseline visit (week 9)and treated with the drugs for 16 weeks.', 'armGroupLabels': ['rivastigmine patch monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420-767', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'The Catholic University of Korea Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '602-715', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Donga University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '641-560', 'city': 'Changwon', 'country': 'South Korea', 'facility': 'Changwon Fatima Hospital', 'geoPoint': {'lat': 35.22806, 'lon': 128.68111}}, {'zip': '700-712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-799', 'city': 'Daejun', 'country': 'South Korea', 'facility': 'Daejun Eulji University Hopistal', 'geoPoint': {'lat': 37.58221, 'lon': 126.74156}}, {'zip': '41-773', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Dongguk University Medical Center', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '412-270', 'city': 'Goyang', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '570-180', 'city': 'Iksan', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha Univeristy Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '405-760', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '602-739', 'city': 'Pusan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Maryknoll Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Bobath Memorial Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyughee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangdong Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sungkyunkwan University, Samsung Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-719', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '431-060', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Eulji Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Seong Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Inha University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inha University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seong Hye Choi', 'oldOrganization': 'Inha University Hospital'}}}}