In a landmark decision, the European Commission has granted EU-wide authorisation for lecanemab, the first medicine to treat mild cognitive impairment in the early stages of Alzheimer’s disease. The decision follows a rigorous scientific evaluation by the European Medicines Agency (EMA), which found that the benefits of lecanemab outweigh its risks in a specific subset of patients.

The treatment is only indicated for individuals who:

• Have early symptoms of Alzheimer’s, including mild cognitive impairment.

• Possess 0 or 1 copy of the ApoE4 gene, a genetic marker linked to higher Alzheimer’s risk.

• Show evidence of amyloid beta plaque buildup in the brain — a hallmark of Alzheimer’s pathology.

Use of the medicine comes with strict risk minimisation conditions, including regular monitoring and specific eligibility criteria, to ensure safe and targeted application.

This approval marks a significant milestone in Europe’s battle against Alzheimer’s disease, offering a new therapeutic pathway for patients in the earliest, potentially most treatable, phase of the disease.

Connection to the AI-Mind Project

The decision resonates closely with the goals of the AI-Mind Project, an EU-funded initiative aiming to develop AI-based tools to detect Alzheimer’s and other neurodegenerative diseases earlier and more accurately. AI-Mind focuses on identifying individuals at risk before symptoms manifest or in very early stages — the very population that lecanemab targets.

By combining early detection (AI-Mind) and early intervention (lecanemab), the EU is aligning cutting-edge diagnostics with targeted treatment to delay or even prevent the progression of dementia.

More information will soon be available in the Union Register of Medicinal Products.
Read the Commission’s full announcement: https://ec.europa.eu/newsroom/sante/items/879055/en