Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT00574132
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2007-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
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': 'C545458', 'term': 'bapineuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'dispFirstSubmitDate': '2013-09-27', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2007-12-10', 'dispFirstSubmitQcDate': '2013-09-27', 'studyFirstSubmitQcDate': '2007-12-13', 'dispFirstPostDateStruct': {'date': '2013-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive and Functional', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Cognitive and Global', 'timeFrame': '18 months'}, {'measure': 'Imaging and biochemical biomarkers of disease status', 'timeFrame': '18 months'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '30412493', 'type': 'DERIVED', 'citation': 'Brashear HR, Ketter N, Bogert J, Di J, Salloway SP, Sperling R. Clinical Evaluation of Amyloid-Related Imaging Abnormalities in Bapineuzumab Phase III Studies. J Alzheimers Dis. 2018;66(4):1409-1424. doi: 10.3233/JAD-180675.'}, {'pmid': '29854935', 'type': 'DERIVED', 'citation': "Samtani MN, Xu SX, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumab. Alzheimers Dement (N Y). 2015 Oct 9;1(3):157-169. doi: 10.1016/j.trci.2015.09.001. eCollection 2015 Nov."}, {'pmid': '29854934', 'type': 'DERIVED', 'citation': "Xu SX, Samtani MN, Russu A, Adedokun OJ, Lu M, Ito K, Corrigan B, Raje S, Brashear HR, Styren S, Hu C. Alzheimer's disease progression model using disability assessment for dementia scores from bapineuzumab trials. Alzheimers Dement (N Y). 2015 Jul 21;1(2):141-149. doi: 10.1016/j.trci.2015.06.005. eCollection 2015 Sep."}, {'pmid': '28269765', 'type': 'DERIVED', 'citation': "Ketter N, Brashear HR, Bogert J, Di J, Miaux Y, Gass A, Purcell DD, Barkhof F, Arrighi HM. Central Review of Amyloid-Related Imaging Abnormalities in Two Phase III Clinical Trials of Bapineuzumab in Mild-To-Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;57(2):557-573. doi: 10.3233/JAD-160216."}, {'pmid': '26208959', 'type': 'DERIVED', 'citation': 'Liu E, Schmidt ME, Margolin R, Sperling R, Koeppe R, Mason NS, Klunk WE, Mathis CA, Salloway S, Fox NC, Hill DL, Les AS, Collins P, Gregg KM, Di J, Lu Y, Tudor IC, Wyman BT, Booth K, Broome S, Yuen E, Grundman M, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Amyloid-beta 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. 2015 Aug 25;85(8):692-700. doi: 10.1212/WNL.0000000000001877. Epub 2015 Jul 24.'}, {'pmid': '24450891', 'type': 'DERIVED', 'citation': "Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839."}]}, 'descriptionModule': {'briefSummary': "This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.\n\nBapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '88 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of probable AD\n* Age from 50 to less than 89\n* Mini-Mental Status Exam score of 16-26 inclusive\n* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD\n* Stable doses of medications (cholinesterase inhibitors and memantine allowed)\n* Caregiver able to attend all clinic visits with patient\n\nExclusion Criteria:\n\n* Significant neurological disease other than AD\n* Major psychiatric disorder\n* Significant systemic illness\n* History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years\n* Smoking greater than 20 cigarettes per day\n* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications\n* Prior treatment experimental immunotherapeutics or vaccines for AD\n* Women of childbearing potential\n* Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body"}, 'identificationModule': {'nctId': 'NCT00574132', 'briefTitle': "Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)", 'organization': {'class': 'INDUSTRY', 'fullName': 'JANSSEN Alzheimer Immunotherapy Research & Development, LLC'}, 'officialTitle': "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.", 'orgStudyIdInfo': {'id': 'ELN115727-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 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