With the EU authorisation of lecanemab for the treatment of Mild Cognitive Impairment (MCI) due to Alzheimer’s disease, health systems are faced with a new challenge: ensuring that people who may benefit from such treatments are identified early and safely. Many current diagnostic tools are invasive, expensive, or not widely available. This risks delaying diagnosis until symptoms are more advanced, reducing the potential benefit of new disease-modifying therapies. Launched in November 2024, the FluiDx-AD project is devel-oping a set of minimally invasive, cost-effective tests using saliva and blood samples. These are intended to support earlier diagnosis, confirmatory testing, and safety monitoring, particularly around the risk of ARIA (amyloid-related imaging abnormalities), which must be carefully managed with anti-amyloid treatments. The project’s aim is to make accurate testing more accessible in real-world settings, beyond specialist memory clinics. As new therapies like lecanemab begin to enter clinical practice, this type of diagnostic support will become increasingly im-portant. The project involves hospitals, universities, SMEs and Alzheimer Europe, working together to improve diagnosis and help health systems adapt to a changing treatment land-scape.
Making diagnosis fit for purpose: Preparing for safe and timely access to new Alzheimer’s treatments
15/04/2025