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

NCT03887455 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1906

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Early Alzheimer's Disease

Interventions

DRUG

Lecanemab IV

Administered as IV infusion.

DRUG

Placebo

Biweekly (once every 2 weeks) administered as IVinfusion.

DRUG

Lecanemab SC

Administered weekly as a SC injection.

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887455 on ClinicalTrials.gov