Roche Divulges New Alzheimer’s Disease Research Data at AAIC 2025

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Editor's note: this story was originally published on PharmTech.com.

On July 28, 2025, Roche announced new data from its development portfolio for Alzheimer’s disease (AD) which the company presented at the 2025 Alzheimer’s Association International Conference (AAIC), held in Toronto, Canada, on July 27–30. The company's research efforts in AD span across both its pharmaceutical and diagnostics portfolios (1).

Pharmaceuticals

On the pharmaceutical portfolio front, the company’s presentations at the conference included the latest results from an ongoing Phase Ib/IIa Brainshuttle AD study, which continue to support the rapid and robust reduction of amyloid plaques, and the design of Phase III studies (TRONTIER 1 and 2) using trontinemab—an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody—for early symptomatic AD. These Phase III studies are planned to start later in 2025. In addition, Roche also plans to conduct an additional Phase III trial that will investigate the use of trontinemab in preclinical AD as part of its growing programs for the disease. This additional trial will focus on individuals at risk of cognitive decline. The goal will be to potentially delay or prevent the progression of AD to the symptomatic stages.

“Alzheimer’s disease represents one of the greatest challenges in healthcare today, and tackling it requires early detection and effective therapeutics,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Roche, in a company press release (1). “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.”

Diagnostics

On the diagnostic portfolio front and using both oral and poster presentations at AAIC 2025, Roche highlighted the potential of its Elecsys pTau217 product as a reliable and accessible blood-based biomarker test, which can provide comparable results to positron emission tomography (PET) scans and cerebrospinal fluid diagnostics for rule-in and rule-out diagnosis of amyloid pathology, a hallmark of AD, across care settings. Elecsys pTau217 will be used in the planned additional Phase III studies (TRONTIER).

“Blood based testing for Alzheimer’s disease has the potential to greatly improve patient access and decrease the time to definitive disease diagnosis,” said Matt Sause, CEO of Roche Diagnostics, in the press release. “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.”

Roche cites that up to 75% of people living with symptoms of AD globally have not been diagnosed. Meanwhile, those who have been diagnosed were said to have waited an average of 2.8 years to get the diagnosis (2). Even fewer have received any form of treatment, according to Roche in the release. The company stated in the release that “[d]iagnostics play a crucial role in addressing the global challenge of Alzheimer’s, not only to detect and identify people with the disease early, even before the first symptoms, but also to rule out those who may or may not benefit from specific treatments” (1).

References

1. Roche. Roche Presents New Insights in Alzheimer’s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC. Press Release. July 27, 2025.
2. Johns Hopkins Bloomberg School of Public Health. Life Expectancy Following Diagnosis of Alzheimer’s Disease Depends on Age at Diagnosis. https://publichealth.jhu.edu/2002/alzheimer-age, Nov. 18, 2002.