Alzheimer’s disease (AD) remains a growing global crisis, with more than 6.5M U.S. patients and costs projected to reach $2.8T by 2030. Recent FDA approvals, such as lecanemab, highlight both opportunities and regulatory divides with EMA. Biotech sponsors are driving innovation with 127 drugs in 164 active trials, including disease-modifying therapies, tau inhibitors, and immunotherapies. Advances in blood-based biomarkers like p-tau217 and p-tau231 enable earlier, less invasive diagnosis, critical for preclinical intervention. CRO partnerships help sponsors design adaptive trials, integrate biomarkers, and improve recruitment, particularly among underrepresented groups.

Join for free to read