Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00795418
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2008-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2012-05-02', 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-11-10', 'dispFirstSubmitQcDate': '2012-05-02', 'studyFirstSubmitQcDate': '2008-11-20', 'dispFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.', 'timeFrame': '52 weeks'}, {'measure': 'Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.', 'timeFrame': '52 weeks'}, {'measure': 'Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.', 'timeFrame': '52 weeks'}]}, 'conditionsModule': {'keywords': ['Active immunization', "Alzheimer's disease", 'Antibody', 'Vaccine', 'Central Nervous System Diseases', 'Neurodegenerative diseases'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '25918556', 'type': 'DERIVED', 'citation': "Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015."}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4704', 'label': 'Results for CCAD106A2202 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and/or female patients between 40 and 85 years of age (both inclusive)\n* Diagnosis of mild Alzheimer's Disease (AD)\n* Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.\n\nExclusion Criteria:\n\n* Previously participated in an AD vaccine study and received active treatment.\n* History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.\n* History or presence of seizures and/or cerebrovascular disease.\n* Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)\n* Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00795418', 'briefTitle': "Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106", 'orgStudyIdInfo': {'id': 'CCAD106A2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAD106', 'interventionNames': ['Biological: CAD106']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}, {'name': 'CAD106', 'type': 'BIOLOGICAL', 'armGroupLabels': ['CAD106']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alpine Clinical Research Center', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Clinical Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Neuroscience Institute', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'MidAmerica NeuroScience Research Foundation', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University College of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'NOCCR Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '75390-9139', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}