Roche Expands Alzheimer’s Research With New Trials, Biomarker Data, And Early Diagnosis Focus

Roche has showcased new data from its Alzheimer's disease research at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto, underscoring its comprehensive approach to tackling the disease. Among the highlights are updated results from the Phase Ib/IIa Brainshuttle™ AD trial, which continues to show rapid and significant reductions in amyloid plaques. Roche also presented the trial designs for its Phase III TRONTIER 1 and 2 studies evaluating trontinemab in patients with early symptomatic Alzheimer’s, with study launches planned for later this year.

“Alzheimer’s disease represents one of the greatest challenges in healthcare today and tackling it requires early detection and effective therapeutics,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Trontinemab is designed to target a key driver of Alzheimer’s disease biology more effectively in the brain.  Combining new treatment avenues with advanced diagnostics may enable earlier and potentially more effective intervention. With plans for Phase III trials in both early symptomatic and preclinical Alzheimer’s disease, we are advancing science with the goal of delaying —and ultimately preventing—progression of this devastating condition.”

In a significant expansion of its Alzheimer's development program, Roche announced a new Phase III clinical trial targeting preclinical Alzheimer’s in individuals at risk of cognitive decline. This trial aims to determine whether trontinemab can delay or prevent the onset of symptomatic Alzheimer’s, potentially shifting the focus of treatment to earlier stages of the disease and improving long-term outcomes.

“Blood-based testing for Alzheimer’s disease has the potential to greatly improve patient access and decrease the time to definitive disease diagnosis. Our data show that the Elecsys pTau217 test performs comparably to PET scans but can be performed with a simple blood draw and analyzed in a routine clinical laboratory. This has the potential to transform the diagnosis of Alzheimer's and provide clear answers to caregivers, patients, and their families,” said Matt Sause, CEO of Roche Diagnostics. 

Roche also spotlighted promising results from its Elecsys® pTau217 blood-based biomarker test. The diagnostic tool demonstrated accuracy comparable to PET scans and cerebrospinal fluid (CSF) testing, offering a more accessible option for early diagnosis. The test, which received FDA Breakthrough Device Designation in 2024, will play a key role in patient selection for the upcoming TRONTIER trials. With a vast majority of Alzheimer’s patients currently undiagnosed or untreated, Roche emphasized the vital importance of early and accurate diagnostics in transforming the Alzheimer’s care pathway.