Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-02 @ 6:48 AM
Study NCT ID:
NCT06810960
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Up to 6 years', 'description': 'AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.'}, {'measure': 'Exposure-adjusted Incidence Rate of AESIs', 'timeFrame': 'Up to 6 years', 'description': 'AESI will include ARIA-E, ARIA-H, symptomatic ARIA-E, symptomatic ARIA-H, and ICH greater-than 1 cm.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Seizure, Anaphylaxis and Death', 'timeFrame': 'Up to 6 years'}, {'measure': 'Exposure-Adjusted Incidence Rate of Seizure, Anaphylaxis and Death', 'timeFrame': 'Up to 6 years'}, {'measure': 'Incidence of AESIs Based on Baseline Characteristics', 'timeFrame': 'Up to 6 years', 'description': "Baseline characteristics will include apolipoprotein E4 (APOE4) genotype, baseline magnetic resonance imaging (MRI) findings, prior Alzheimer's disease (AD) treatments, and antithrombotic therapy."}, {'measure': 'Exposure-adjusted Incidence Rate of AESIs Based on Baseline Characteristics', 'timeFrame': 'Up to 6 years', 'description': 'Baseline characteristics will include APOE4 genotype, baseline MRI findings, prior AD treatments, and antithrombotic therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'Lecanemab', 'ARIA'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate safety of lecanemab in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 centimeter (cm) in participants treated with lecanemab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants prescribed with lecanemab by a physician in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older at consent\n* Prior to JOY-ALZ enrollment, the treating physician confirms that the participant is suitable for lecanemab treatment, as per the approved indications in South Korea\n* Has an identified study partner who provides separate written informed consent\n* Provides written informed consent for the use of medical information to be shared with Eisai Korea Inc.\n\nExclusion Criteria:\n\n* Currently participating in an interventional clinical study\n* Has contraindications for lecanemab according to the approved prescribing information in South Korea'}, 'identificationModule': {'nctId': 'NCT06810960', 'briefTitle': "A Postmarketing Study of Lecanemab in South Korean Participants With Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "A 6-Year Postmarketing Safety and Clinical Outcome Study of Lecanemab in the Treatment of Alzheimer's Disease Using Real-World Data From South Korean Patients Enrolled Into the South Korean JOint RegistrY for ALZheimer's Treatment and Diagnostics (JOY-ALZ) Registry", 'orgStudyIdInfo': {'id': 'BAN2401-M082-503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lecanemab', 'description': 'Participants treated with lecanemab in accordance with the approved prescribing information by a physician in routine clinical practice (postmarketing). Data will be collected from by JOY-ALZ registry.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This is a non-interventional study.', 'armGroupLabels': ['Lecanemab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07110', 'city': 'Nutley', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eisai Trial Site #1', 'geoPoint': {'lat': 40.82232, 'lon': -74.15987}}], 'centralContacts': [{'name': 'Medical department Serena SoYoun Kwon', 'role': 'CONTACT', 'email': 's-kwon@eisaikorea.com', 'phone': '+82-2-3451-5533'}]}, '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 Korea Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}