Eisai Clinical Trials
Study Overview
BAN2401
lecanemab
NCT03887455, 2018-004739-58, 2024-510887-22, jRCT2081214685, JapicCTI-194759
Mar 2019 -
Early Alzheimer's Disease
1. Core Study: Change from Baseline in the CDR-SB at 18 Months [Time Frame: Baseline, 18 months]
2. Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase]
3. Extension Phase: Change from Core Study Baseline in CDR-SB [Time Frame: Baseline up to Month 66]
4. Extension Phase Part B: Number of Participants Exposed to Lecanemab [Time Frame: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)]
2. Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase]
3. Extension Phase: Change from Core Study Baseline in CDR-SB [Time Frame: Baseline up to Month 66]
4. Extension Phase Part B: Number of Participants Exposed to Lecanemab [Time Frame: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)]
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Males and females 50 Years to 90 Years (Adult, Older Adult)
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Active, not recruiting -
Phase 3
Australia, Canada, China, France, Germany, Italy, Japan, Korea, Republic of, Russian Federation, Singapore, Spain, Sweden, United Kingdom, United States See moreData Sharing
ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.
CSDR Sharing is not available for this study.
CSDR Availability Clinical Trial Data Redacted documents may be available upon request for this study.
Document type Availability Protocol SAP Sample CRF Full CSR