# A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Clinical trial · Eisai Inc.

- Archive id: nct:NCT03887455
- Published: 2019-03-25
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03887455
- Source URL: https://clinicaltrials.gov/study/NCT03887455
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- acronym: Clarity AD
- status: ACTIVE_NOT_RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 1906
- sponsor: Eisai Inc.
- conditions: Early Alzheimer's Disease
- interventions: DRUG: Lecanemab IV; DRUG: Placebo; DRUG: Lecanemab SC
- start date: 2019-03-27
- start date type: ACTUAL
- primary completion date: 2026-12-31
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Alzheimer's, Parkinson's & Neurodegeneration](https://space-kitty.com/topics/neurodegeneration)

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