A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
← catalyst calendarNCT03887455 · readout in 1,046 d
Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →. With Biogen.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,906actual
Sites
247
Countries
Australia, Canada, China +11
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-27 | actual | When the study began enrolling |
| Primary completion | 2029-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2019-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Early Alzheimer's Disease
Interventions
- Drug: Lecanemab IV — also filed as BAN2401
- Drug: Placebo
- Drug: Lecanemab SC — also filed as BAN2401
Primary outcomes
what the primary-completion date above is the date OFCore Study: Change from Baseline in the CDR-SB at 18 Months
measured Baseline, 18 months
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
measured 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
measured Baseline up to Month 66
Extension Phase Part B: Number of Participants Exposed to Lecanemab
measured From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)
Publications
- PMID 42552749 — linked by the registry
- PMID 41689888 — linked by the registry
- PMID 41170658 — linked by the registry
- PMID 40042496 — linked by the registry
- PMID 39575854 — linked by the registry
- PMID 38940656 — linked by the registry
- PMID 38730496 — linked by the registry
- PMID 37009976 — linked by the registry
- PMID 36449413 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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