SHERIDAN, WYOMING – July 29, 2025 – Roche is accelerating its multi-modal approach to Alzheimer’s disease, unveiling new data at the Alzheimer’s Association International Conference (AAIC) that spotlight the therapeutic potential of trontinemab and the diagnostic promise of its Elecsys® pTau217 blood test. Together, these innovations signal a possible shift toward earlier, more accessible, and more precise detection and treatment of the world’s most prevalent neurodegenerative disease.
Trontinemab shows rapid amyloid clearance with low ARIA risk
At the center of Roche’s pharmaceutical portfolio is trontinemab, an investigational monoclonal antibody built on the company’s proprietary Brainshuttle™ platform. In new data from the Phase Ib/IIa Brainshuttle AD study, trontinemab demonstrated a 91% conversion to amyloid PET-negative status at 3.6 mg/kg dosing after 28 weeks, with deep clearance in 72% of participants. These results underscore trontinemab’s potential to deliver fast and substantial reductions in amyloid plaque burden while maintaining a low incidence (<5%) of amyloid-related imaging abnormalities-edema (ARIA-E), all of which were mild.
Roche has now detailed the designs of its pivotal Phase III TRONTIER 1 and 2 trials in early symptomatic Alzheimer’s disease, measuring cognitive and functional changes via the Clinical Dementia Rating–Sum of Boxes (CDR-SB). A separate Phase III study is also planned to test trontinemab in preclinical Alzheimer’s, targeting patients at high risk of cognitive decline in an effort to delay or prevent symptom onset.
pTau217 blood test may disrupt PET and CSF diagnostic reliance
From a diagnostics standpoint, Roche continues to strengthen the case for Elecsys® pTau217 as a first-line rule-in and rule-out test for amyloid pathology. The test—already designated as a Breakthrough Device by the FDA—was shown to deliver PET-comparable diagnostic accuracy with a simple blood draw. In new real-world U.S. data, the Elecsys pTau181 test reduced unnecessary imaging and cerebrospinal fluid (CSF) procedures in primary care settings, streamlining access and lowering costs.
“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. “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 aligns with major trends in Alzheimer’s care evolution
Industry-wide, there is mounting pressure to shift Alzheimer’s diagnosis and treatment earlier in the disease timeline. Roche’s dual strategy—pairing targeted therapies with scalable diagnostics—mirrors this movement toward preclinical intervention and personalized care. Competitor efforts, including lecanemab and donanemab, focus largely on early symptomatic stages, but Roche’s push into the preclinical space may broaden the patient funnel and differentiate trontinemab within a crowded biologics pipeline.
Furthermore, the combination of Brainshuttle technology and blood-based diagnostics positions Roche to address known limitations in monoclonal antibody delivery and Alzheimer’s detection infrastructure.
Trontinemab may redefine how monoclonal antibodies reach the brain
Trontinemab’s underlying Brainshuttle mechanism—leveraging a transferrin receptor transport module—marks a step-change in how amyloid-targeting therapies engage the central nervous system. Unlike conventional monoclonal antibodies, which struggle to cross the blood-brain barrier, trontinemab is engineered for high CNS exposure at low doses, maximizing plaque clearance efficiency while minimizing systemic burden.
“Trontinemab is designed to target a key driver of Alzheimer’s disease biology more effectively in the brain,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer at Roche. “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.”
Strategic value for healthcare providers and health systems
For providers and payers, Roche’s Alzheimer’s portfolio could support a transition to scalable, cost-effective care models. By incorporating plasma-based triage tools and novel biologics that demonstrate fast-acting efficacy with favorable safety, healthcare systems may reduce reliance on specialist imaging and invasive diagnostics—cutting delays and broadening access.
Additionally, tools like the Elecsys pTau217 assay could enable early-stage identification and enrollment in clinical trials, especially for underrepresented populations, helping fulfill calls for more equitable research and care.
A dual-platform path to Alzheimer’s innovation
Roche’s end-to-end strategy—spanning advanced diagnostics and biologics development—places the company at the forefront of next-generation Alzheimer’s care. With trontinemab poised for Phase III in multiple patient segments and Elecsys pTau217 gaining real-world traction, Roche is building infrastructure for a disease-modifying ecosystem that could shift diagnosis and intervention upstream.
Learn more at www.roche.com