Alzheimer Europe has signed a statement coordinated by the InRAD (International Registry for Alzheimer’s Disease and Other Dementias) Foundation, welcoming the approval of lecanemab and recognising the need to address questions surrounding its clinical use, including its safety and effectiveness in the real world. The letter notes that the approval of lecanemab comes with the requirement for Controlled Access Programs (CAP) and Post Authorization Studies (PASS), highlighting the risk of pharmaceutical companies acting independently in relation to transparency, collaboration, limited depth of data collection and restricted long-term monitoring. As such, the signatories propose that the EMA and EU require companies to use common infrastructure in the field, capable of supporting multiple treatments, ensuring alignment with healthcare professionals' needs, as well as allowing for the integration of patient-reported outcomes, avoiding redundant efforts, facilitating comparisons between treatments, and providing high-quality data.
Additionally, they advocate for international collaboration in collecting meaningful data for Alzheimer’s disease (AD) and other dementias, noting that aligned post-authorisation data collection would enable effective management and monitoring of therapies, as well as continuous improvement in clinical practice. The note that recent discussions at the AD/PD 2025 Conference highlighted the need for a coordinated, disease-focused registry approach at the European level, rather than separate registries for specific medications. It is explained that no current AD registry meets the scale or safety standards required for regulatory decision-making. The case is made that a single, well-designed foundation will be more efficient and scalable than multiple fragmented efforts, with InRAD being well-placed to develop such infrastructure.