Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 8:33 PM
Study NCT ID:
NCT01343966
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
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': 'C573372', 'term': 'crenezumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2016-08-10', 'completionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2011-04-27', 'dispFirstSubmitQcDate': '2016-08-10', 'studyFirstSubmitQcDate': '2011-04-27', 'dispFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog) score", 'timeFrame': 'From baseline to Week 73'}, {'measure': 'Change in Clinical Dementia Rating, Sum of Boxes (CDR-SOB) score', 'timeFrame': 'From baseline to Week 73'}], 'secondaryOutcomes': [{'measure': "Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) score", 'timeFrame': 'From baseline to Week 73'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '36946448', 'type': 'DERIVED', 'citation': "Polhamus DG, Dolton MJ, Rogers JA, Honigberg L, Jin JY, Quartino A. Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. J Prev Alzheimers Dis. 2023;10(2):212-222. doi: 10.14283/jpad.2023.13."}, {'pmid': '31969177', 'type': 'DERIVED', 'citation': "Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2."}]}, 'descriptionModule': {'briefSummary': "This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria\n* Mini-Mental State Examination (MMSE) score of 18-26 points at screening\n* Geriatric Depression Scale (GDS-15) score of \\< 6\n* Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)\n* If receiving concurrent AD treatment, patient must be on the medication for at least 3 months at a stable dose for at least 2 months prior to randomization.\n\nExclusion Criteria:\n\n* Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care\n* History or presence of clinically evident vascular disease potentially affecting the brain\n* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma\n* Hospitalization within 4 weeks prior to screening\n* Previous treatment with MABT5102A or any other therapeutic that targets Abeta\n* Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed"}, 'identificationModule': {'nctId': 'NCT01343966', 'briefTitle': "A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': "A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)", 'orgStudyIdInfo': {'id': 'ABE4869g'}, 'secondaryIdInfos': [{'id': 'ABBY', 'type': 'OTHER', 'domain': 'Genentech'}, {'id': 'GN00761', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Subcutaneous cohort exp', 'interventionNames': ['Drug: MABT5102A']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Intravenous cohort exp', 'interventionNames': ['Drug: MABT5102A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Subcutaneous cohort', 'description': 'Repeating subcutaneous injection', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Intravenous cohort', 'description': 'Repeating intravenous infusion', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'MABT5102A', 'type': 'DRUG', 'description': 'Repeating subcutaneous injection', 'armGroupLabels': ['Part 1: Subcutaneous cohort exp']}, {'name': 'MABT5102A', 'type': 'DRUG', 'description': 'Repeating intravenous infusion', 'armGroupLabels': ['Part 2: Intravenous cohort exp']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Repeating subcutaneous injection', 'armGroupLabels': ['Part 1: Subcutaneous cohort']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Repeating intravenous infusion', 'armGroupLabels': ['Part 2: Intravenous cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Pharmacology Research Inst', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Margolin Brain Institute', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': "Univ of CA San Diego; 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