Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT03668405
Status:
TERMINATED
Last Update Posted:
2019-11-21
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'New data: The study was terminated based on new efficacy data from another study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)', 'timeFrame': 'Baseline to week 96', 'description': 'Based on the safety assessments (clinical safety laboratory tests, vital signs, ECGs, physical examinations (including neurological), Immunisation-Related Events (IRE) (selected from Brighton Collaboration guidelines) and magnetic resonance imaging (MRI) safety scans)'}, {'measure': 'Aβ-specific antibody titre in plasma', 'timeFrame': 'Baseline to week 96'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.\n* The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.\n* The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study\n\nMain exclusion criteria:\n\n* The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.\n* The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability\n\nMore inclusion and exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03668405', 'briefTitle': "A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': "Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': '16026B'}, 'secondaryIdInfos': [{'id': '2014-001797-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lu AF20513 high dose', 'interventionNames': ['Drug: Lu AF20513']}], 'interventions': [{'name': 'Lu AF20513', 'type': 'DRUG', 'description': 'Injection', 'armGroupLabels': ['Lu AF20513 high dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Turku', 'country': 'Finland', 'facility': 'FI001', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Malmo', 'country': 'Sweden', 'facility': 'SE002', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'city': 'Mölndal', 'country': 'Sweden', 'facility': 'SE003', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'SE001', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}