18 Nov How decentralisation can fill the gaps in Alzheimer’s research

By Jenna Philpott, Clinical Trials Arena

In a new era of Alzheimer’s disease research, the emergence of blockbuster therapies like Eli Lilly’s Kisunla (donanemab) and Eisai and Biogen’s Leqembi (lecanemab) offer renewed hope to patients and researchers.

Despite their promise, these therapies have faced significant regulatory and access challenges. In July, the European Medicines Agency (EMA) said Leqembi’s efficacy was “not large enough” to outweigh its safety risks, and in October, the UK’s National Institute for Health and Care Excellence (NICE) recommended against the widespread use of Kisunla.

These setbacks highlight the complex path forward for proving effectiveness with innovative therapies, as researchers and trial sponsors find ways to balance clinical rigor with the unique needs of a patient population experiencing cognitive decline. Read more…