Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-28 @ 4:07 AM
Study NCT ID:
NCT06322667
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2024-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-14', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)', 'timeFrame': 'Up to 156 weeks'}, {'measure': 'Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA', 'timeFrame': 'Up to 156 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Infusion Related Reaction', 'timeFrame': 'Up to 156 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Early Alzheimer's Disease", 'Lecanemab', 'ARIA'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants prescribed lecanemab by a physician in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants who are treated with lecanemab in routine clinical practice\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06322667', 'briefTitle': "A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "A Multicenter, Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimer's Disease and Treated With Lecanemab", 'orgStudyIdInfo': {'id': 'BAN2401-J081-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'description': 'Participants prescribed lecanemab by a physician in routine clinical practice (post-marketing surveillance) will be observed prospectively for up to a maximum of 156 weeks or to the time of discontinuation, whichever occurs first.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is a non-interventional study.', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hiroshima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Eisai trial site 2', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Eisai trial site 3', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Eisai trial site 1', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Eisai Inquiry Service.', 'role': 'CONTACT', 'email': 'eisai-chiken_hotline@hhc.eisai.co.jp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}