From 27 to 30 July, researchers from Roche presented new data from across their Alzheimer’s disease diagnostics and pharmaceutical portfolios at the Alzheimer’s Association International Conference (AAIC) in Toronto. Findings from the Phase Ib/IIa Brainshuttle™ AD study showed that trontinemab, an investigational bispecific monoclonal antibody, led to rapid and sustained clearance of amyloid plaques. In the highest dose cohort, 91% of participants became amyloid PET negative (below 24 centiloid positivity threshold) after 28 weeks of treatment, with <5% experiencing “amyloid-related imaging abnormalities-edema/effusion” (ARIA-E). Roche also shared the design of its upcoming Phase III TRONTIER 1 and 2 studies, which will evaluate trontinemab in early symptomatic Alzheimer’s disease.
A separate Phase III trial is planned to take place in 2025 in preclinical Alzheimer’s disease for individuals at high risk of cognitive decline. In diagnostics, Roche presented real-world evidence supporting the pTau217 blood test as a reliable standalone tool to rule in or rule out amyloid pathology. Results showed comparable performance to PET scans and cerebrospinal fluid measures, with the advantage of a less invasive and more accessible procedure. The test will be used in the TRONTIER trial screening process to support broader participation. The official press release can be read here: https://www.roche.com/media/releases/med-cor-2025-07-28.htm