Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT01485302
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2011-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with adverse events', 'timeFrame': '10 months'}], 'secondaryOutcomes': [{'measure': 'AUC', 'timeFrame': '1 to 112 days after dosing'}, {'measure': 'Cmax', 'timeFrame': '1 to 112 days after dosing'}, {'measure': 't1/2z', 'timeFrame': '1 to 112 days after dosing'}, {'measure': 'brain magnetic resonance imaging', 'timeFrame': '10 months'}, {'measure': 'hematology, biochemistry, coagulation', 'timeFrame': '10 months'}, {'measure': 'vital signs, ECG', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["mild to moderate Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\n\\- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)\n\nSecondary Objective:\n\n\\- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients", 'detailedDescription': '14.5 to 22 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive\n* Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association\n* Mini-mental state examination (MMSE)\n* In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment\n* Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease\n* Rosen Modified Hachinski Ischemic score\n* If on symptomatic treatment for Alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening\n\nExclusion criteria:\n\n* Clinically significant neurological disease other than Alzheimer's disease\n* Had a major psychiatric disorder\n* Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)\n* History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.\n* History or presence of clinically relevant cardiac disease.\n* Currently taking anticonvulsants, anti-Parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. Concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (ASA) at a dose ≤ 160 mg/day;\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01485302', 'briefTitle': "Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.", 'orgStudyIdInfo': {'id': 'TDR12399'}, 'secondaryIdInfos': [{'id': '2011-002910-35', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1120-0550', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Dose 1 IV infusion', 'interventionNames': ['Drug: SAR228810']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Dose 2 IV infusion', 'interventionNames': ['Drug: SAR228810']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Dose 3 IV infusion', 'interventionNames': ['Drug: SAR228810']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Dose 4 IV infusion', 'interventionNames': ['Drug: SAR228810']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'Dose 1 SC injection', 'interventionNames': ['Drug: SAR228810']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 6', 'description': 'Dose 2 SC injection', 'interventionNames': ['Drug: SAR228810']}], 'interventions': [{'name': 'SAR228810', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution\n\nRoute of administration: intravenous', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}, {'name': 'SAR228810', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution\n\nRoute of administration: subcutaneous', 'armGroupLabels': ['Cohort 5', 'Cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 100001', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Investigational Site Number 250001', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Investigational Site Number 250002', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '2333 CL', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Investigational Site Number 528001', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '9301', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Investigational Site Number 710001', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '21224', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Investigational Site Number 752003', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '43141', 'city': 'Mölndal', 'country': 'Sweden', 'facility': 'Investigational Site Number 752002', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Investigational Site Number 752001', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}