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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT03887455). This is a study registration, not published results. Lead sponsor: Eisai Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1906 participants (ACTUAL). Conditions: Early Alzheimer's Disease. Interventions: DRUG: Lecanemab IV; DRUG: Placebo; DRUG: Lecanemab SC. Primary outcome measures: Core Study: Change from Baseline in the CDR-SB at 18 Months , Baseline, 18 months; Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) , From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase; Extension Phase: Change from Core Study Baseline in CDR-SB , Baseline up to Month 66; Extension Phase Part B: Number of Participants Exposed to Lecanemab , From 48th month in extension phase part A to the end of extension phase part B (up to 24 months). Brief summary: This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.