# Lecanemab in Early Alzheimer’s Disease (CLARITY AD)

Source: https://onco.cc/key-papers/da-paper-clarity-ad/  
OnCo record `da-paper-clarity-ad` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The published CLARITY AD paper reports the phase 3 lecanemab trial in early Alzheimer’s disease. Read the paper and the FDA communication together.

## Summary

Randomised, placebo-controlled trial in early symptomatic Alzheimer’s disease with confirmed amyloid. ARIA was the principal safety theme. This atlas records the trial and this paper as separate objects so a reader can walk from the product to the study to the publication.

## Fields

- Kind: Key paper
- Last checked: 2026-09-21
- Tags: dementia-atlas
- Journal: New England Journal of Medicine
- Year: 2023
- DOI: 10.1056/NEJMoa2212948
- Authors: van Dyck CH, et al.
- Findings: Primary clinical endpoint favoured lecanemab versus placebo in the enrolled population.; ARIA occurred, more often in ApoE ε4 carriers.
- What it means: This is the main published efficacy trial behind the US traditional approval of lecanemab. A mean scale change is not a promise for one person.
- Caveats: Trial cohorts are not the same as mixed-pathology clinic populations.; Individual benefit cannot be read from a group mean.

## Sources

- DOI: https://doi.org/10.1056/NEJMoa2212948
- ClinicalTrials.gov NCT03887455: https://clinicaltrials.gov/study/NCT03887455

## Connected records

- diagnoses: [Alzheimer’s disease](https://onco.cc/diagnoses/alzheimers-disease/)
- drugs: [Lecanemab](https://onco.cc/drugs/da-lecanemab/)
- trials: [CLARITY AD](https://onco.cc/trials/da-trial-clarity-ad/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/da-journal-nejm/)

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