AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
← catalyst calendarNCT04468659 · readout in 855 d
Sponsored by Eisai Inc. (industry) · 4523.T — their whole pipeline →. With Alzheimer's Clinical Trials Consortium, Biogen, National Institute on Aging (NIA).
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,400estimated
Sites
107
Countries
Australia, Canada, Japan +4
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 | 2020-07-14 | actual | When the study began enrolling |
| Primary completion | 2028-12-21 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-01-16 | estimated | The whole study's end, after follow-up |
| First posted | 2020-07-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Preclinical Alzheimer's Disease
- Early Preclinical Alzheimer's Disease
Interventions
- Drug: Lecanemab — also filed as BAN2401
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFA45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216
measured Baseline, Week 216
A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216
measured Baseline, Week 216
Publications
- PMID 38940656 — linked by the registry
- PMID 38629508 — linked by the registry
- PMID 37932961 — linked by the registry
- PMID 37131229 — 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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