Roche announced new data from its Alzheimer’s disease portfolio at the Alzheimer’s Association International Conference (AAIC), taking place in Toronto, Canada, from July 27 to 30. The findings reflect Roche’s comprehensive strategy to address Alzheimer’s across the full continuum of care.
Key oral presentations feature updated results from the ongoing Phase Ib/IIa Brainshuttle™ AD study, which continue to demonstrate rapid and sustained amyloid plaque reduction. The company also shared the design of its upcoming Phase III TRONTIER 1 and 2 studies investigating trontinemab in early symptomatic Alzheimer’s, with study initiation planned for later this year. In addition, Roche announced plans to launch another Phase III trial evaluating trontinemab in individuals with preclinical Alzheimer’s disease who are at risk of cognitive decline—aimed at delaying or preventing the onset of symptoms.
“Alzheimer’s disease remains one of the most significant challenges in modern medicine, requiring both early detection and innovative treatments,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “Trontinemab is engineered to more effectively target Alzheimer’s pathology in the brain. By pairing novel therapeutics with advanced diagnostics, we hope to enable earlier and more effective interventions, potentially slowing or even preventing disease progression.”
Roche also presented late-breaking data on its Elecsys® pTau217 blood test, a promising biomarker tool that offers diagnostic performance comparable to PET imaging and cerebrospinal fluid (CSF) testing for detecting amyloid pathology. The test, which received FDA Breakthrough Device Designation in 2024, will be integrated into the TRONTIER studies to support early diagnosis and patient selection.
“Blood-based testing could revolutionize Alzheimer’s diagnosis by improving accessibility and reducing the time to a definitive diagnosis,” said Matt Sause, CEO of Roche Diagnostics. “Our Elecsys pTau217 assay delivers comparable accuracy to PET scans but requires only a standard blood draw and lab analysis, potentially streamlining the diagnostic process for patients, families, and clinicians.”
Globally, an estimated 75% of people with Alzheimer’s symptoms remain undiagnosed, and those who are diagnosed typically wait an average of 2.8 years—often without receiving any form of treatment. Roche emphasizes the critical role of diagnostics not only in early detection but also in ruling out patients unlikely to benefit from specific therapies, thereby guiding appropriate clinical care.