Alzheimer’s Breakthrough: New Monoclonal Antibodies Slow Cognitive Decline
Following decades in which no single molecule altered the clinical trajectory of neurodegenerative decline, two monoclonal antibodies have secured regulatory clearance. Lecanemab and donanemab target the beta-amyloid proteins that form destructive plaques inside the brain. Administered via intravenous infusion, these biological therapeutics bind directly to accumulated deposits and trigger their clearance, a physiological reduction confirmed through neuroimaging.
- Ces traitements ont déjà montré qu’en ciblant ces plaques chez des patientes et patients symptomatiques, on peut ralentir la progression de 20 à 30 % sur dix-huit mois.
- Therapeutic administration carries a significant risk of amyloid-related imaging abnormalities, including cerebral edema and microhemorrhages, necessitating rigorous MRI monitoring.
Regulatory Hurdles and Timelines for Lecanemab and Donanemab
The path to European authorization required extensive regulatory review. Lecanemab initially received a negative opinion from the European Medicines Agency committee, before a re-evaluation yielded a positive recommendation and subsequent marketing authorization on April 15, 2025.
Quantifying Efficacy Versus Disease Progression
Clinical efficacy is measured via an 18-month period where higher scores indicate worsening clinical status. At the 18-month mark, the net difference between lecanemab and placebo cohorts sits at approximately 0.45 points, while donanemab achieves a 0.7-point variance.
Managing Amyloid-Related Imaging Abnormalities
Consequently, clinical guidelines mandate serial neuroimaging throughout the course of treatment and strictly contraindicate administration in patients receiving anticoagulants.

PrevenTRON Study Tests Therapies for Asymptomatic Amyloid Accumulation
Access to approved therapies remains limited by strict eligibility criteria.
Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.