CLARITY AD Extension — Lecanemab Long-Term Safety Study
Open-label extension of the Phase 3 lecanemab trial, examining long-term safety and efficacy in early Alzheimer's disease. Canadian sites recruiting.
- Phase
- Phase 3 Extension
- Location
- 📍 Toronto ON, Vancouver BC, Montreal QC
- Sponsor
- Eisai / Biogen
- Last updated
- June 14, 2026
Eligibility
Adults aged 50-90 with early Alzheimer's disease (MCI or mild dementia stage). Must have completed or be eligible for the original CLARITY AD trial. Confirmed amyloid pathology required.
This open-label extension study follows participants from the original CLARITY AD Phase 3 trial, examining the long-term safety profile and sustained efficacy of lecanemab (Leqembi) in early Alzheimer’s disease.
Lecanemab received FDA approval in the United States in 2023 and is currently under Health Canada review. This extension trial provides access to the treatment for eligible Canadians while the approval process continues.
What participants receive: Lecanemab infusion every two weeks. Regular MRI monitoring. Cognitive assessments every 6 months. Full trial medical team support.
What to discuss with your doctor: This trial requires confirmed amyloid pathology — typically via PET scan or CSF analysis. If your parent has early-stage Alzheimer’s and has not had amyloid confirmation, ask the family doctor about a referral for assessment. The trial team can advise on eligibility.
Important note: Lecanemab carries a risk of ARIA (amyloid-related imaging abnormalities) — a form of brain swelling that occurs in some participants. The trial monitors for this closely. Discuss the risk-benefit profile with a neurologist before pursuing enrollment.