Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 11:35 AM
Study NCT ID:
NCT00531804
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
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': 'C571128', 'term': 'gantenerumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2007-09-18', 'studyFirstSubmitQcDate': '2007-09-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs, laboratory parameters, vital signs.', 'timeFrame': 'Throughout study'}, {'measure': 'Pharmacokinetic parameters of R1450 in plasma', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'CSF biomarkers, clinical efficacy parameters.', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is \\<100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 50-90 years of age;\n* diagnosis of probable Alzheimer Disease, with symptoms \\>=1 year prior to screening;\n* meets DSM-IV criteria for Alzheimer-type dementia;\n* stabilised on approved medications for treatment of Alzheimer Disease for \\>=4 months prior to baseline.\n\nExclusion Criteria:\n\n* active major depressive disorder, or a history of bipolar disorder;\n* history of schizophrenia;\n* concurrent participation in a non-pharmacological trial with a key objective of improving cognition;\n* prior randomisation in any R1450 trial.'}, 'identificationModule': {'nctId': 'NCT00531804', 'briefTitle': 'A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients', 'orgStudyIdInfo': {'id': 'NN19866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: gantenerumab']}], 'interventions': [{'name': 'gantenerumab', 'type': 'DRUG', 'description': 'Administered iv at escalating doses (7 cohorts)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '1081 GM', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'FY20JH', 'city': 'Blackpool', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'G20 0XA', 'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SO30 3JB', 'city': 'Southampton', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SN3 6BW', 'city': 'Swindon', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}