Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceutical portfolios at AAIC
Roche (OTCQX:RHHBY) presented significant advances in Alzheimer's disease research at AAIC 2025. Their investigational drug trontinemab showed promising Phase Ib/IIa results with 91% of participants becoming amyloid PET negative and ARIA-E rates remaining below 5%. The company announced plans for two Phase III trials (TRONTIER 1 and 2) in early symptomatic Alzheimer's, plus a new Phase III trial for preclinical Alzheimer's.
Additionally, Roche's Elecsys pTau217 blood test, which received FDA Breakthrough Device Designation, demonstrated comparable accuracy to PET scans in detecting amyloid pathology. This diagnostic advancement could significantly improve early detection and treatment access, addressing the critical issue where 75% of Alzheimer's cases globally remain undiagnosed.
Roche (OTCQX:RHHBY) ha presentato importanti progressi nella ricerca sull'Alzheimer all'AAIC 2025. Il loro farmaco sperimentale trontinemab ha mostrato risultati promettenti nelle fasi Ib/IIa con il 91% dei partecipanti diventati negativi all'amiloide PET e tassi di ARIA-E inferiori al 5%. L'azienda ha annunciato l'avvio di due studi di Fase III (TRONTIER 1 e 2) per l'Alzheimer sintomatico precoce, oltre a un nuovo studio di Fase III per l'Alzheimer preclinico.
Inoltre, il test del sangue Elecsys pTau217 di Roche, che ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA, ha dimostrato un'accuratezza comparabile alle scansioni PET nel rilevare la patologia amiloide. Questo progresso diagnostico potrebbe migliorare notevolmente la diagnosi precoce e l'accesso ai trattamenti, affrontando il problema critico per cui il 75% dei casi di Alzheimer nel mondo rimane non diagnosticato.
Roche (OTCQX:RHHBY) presentó avances significativos en la investigación del Alzheimer en la AAIC 2025. Su fármaco experimental trontinemab mostró resultados prometedores en las fases Ib/IIa con el 91% de los participantes volviéndose negativos en PET de amiloide y tasas de ARIA-E por debajo del 5%. La compañía anunció planes para dos ensayos de Fase III (TRONTIER 1 y 2) en Alzheimer sintomático temprano, además de un nuevo ensayo de Fase III para Alzheimer preclínico.
Además, la prueba sanguínea Elecsys pTau217 de Roche, que recibió la Designación de Dispositivo Innovador de la FDA, demostró una precisión comparable a las tomografías PET para detectar la patología amiloide. Este avance diagnóstico podría mejorar significativamente la detección temprana y el acceso al tratamiento, abordando el problema crítico de que el 75% de los casos de Alzheimer a nivel mundial permanecen sin diagnosticar.
로슈(OTCQX:RHHBY)는 AAIC 2025에서 알츠하이머병 연구의 중요한 진전을 발표했습니다. 그들의 실험 약물 trontinemab은 1b/2a상 시험에서 참가자의 91%가 아밀로이드 PET 음성으로 전환되었으며 ARIA-E 발생률은 5% 미만으로 유지되었습니다. 회사는 초기 증상 알츠하이머병을 대상으로 하는 두 건의 3상 임상시험(TRONTIER 1 및 2)과 전임상 알츠하이머병을 위한 새로운 3상 임상시험 계획을 발표했습니다.
또한, FDA 혁신 의료기기 지정(Breakthrough Device Designation)을 받은 로슈의 Elecsys pTau217 혈액 검사는 아밀로이드 병변 탐지에서 PET 스캔과 유사한 정확도를 보였습니다. 이 진단 기술의 발전은 조기 발견과 치료 접근성을 크게 향상시켜 전 세계 알츠하이머 환자의 75%가 진단받지 못하는 심각한 문제를 해결할 수 있을 것입니다.
Roche (OTCQX:RHHBY) a présenté des avancées majeures dans la recherche sur la maladie d'Alzheimer lors de l'AAIC 2025. Leur médicament expérimental trontinemab a montré des résultats prometteurs en phase Ib/IIa avec 91 % des participants devenant négatifs à la PET amyloïde et un taux d'ARIA-E inférieur à 5 %. L'entreprise a annoncé le lancement de deux essais de phase III (TRONTIER 1 et 2) pour la maladie d'Alzheimer symptomatique précoce, ainsi qu'un nouvel essai de phase III pour la maladie d'Alzheimer préclinique.
Par ailleurs, le test sanguin Elecsys pTau217 de Roche, qui a reçu la désignation de dispositif révolutionnaire par la FDA, a démontré une précision comparable aux scintigraphies PET pour détecter la pathologie amyloïde. Cette avancée diagnostique pourrait considérablement améliorer la détection précoce et l'accès aux traitements, répondant au problème critique selon lequel 75 % des cas d'Alzheimer dans le monde restent non diagnostiqués.
Roche (OTCQX:RHHBY) präsentierte bedeutende Fortschritte in der Alzheimer-Forschung auf der AAIC 2025. Ihr experimentelles Medikament trontinemab zeigte vielversprechende Ergebnisse in Phase Ib/IIa mit 91 % der Teilnehmer, die amyloid PET-negativ wurden, und ARIA-E-Raten unter 5 %. Das Unternehmen kündigte Pläne für zwei Phase-III-Studien (TRONTIER 1 und 2) bei früh symptomatischem Alzheimer sowie eine neue Phase-III-Studie für präklinischen Alzheimer an.
Darüber hinaus zeigte der von Roche entwickelte Elecsys pTau217-Bluttest, der die FDA Breakthrough Device Designation erhalten hat, eine vergleichbare Genauigkeit wie PET-Scans bei der Erkennung von Amyloid-Pathologie. Dieser diagnostische Fortschritt könnte die Früherkennung und den Zugang zu Behandlungen erheblich verbessern und damit das kritische Problem angehen, dass 75 % der Alzheimer-Fälle weltweit unentdeckt bleiben.
- 91% of participants became amyloid PET negative with trontinemab treatment
- Favorable safety profile with ARIA-E rates below 5%
- Elecsys pTau217 blood test shows comparable accuracy to PET scans
- FDA Breakthrough Device Designation received for Elecsys pTau217
- Expansion of clinical program with new Phase III trial for preclinical Alzheimer's
- Current 2.8-year average delay in Alzheimer's diagnosis
- 75% of global Alzheimer's cases remain undiagnosed
- Trontinemab’s Phase Ib/IIa Brainshuttle™ AD study continues to show rapid and robust clearance of amyloid plaques, with
91% becoming amyloid PET negative and ARIA-E remaining <5% - Design of the Phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer’s disease featured, with initiation planned in 2025
- Plans for new Phase III trial investigating trontinemab in preclinical Alzheimer’s disease, in people at high risk of cognitive decline
- New real-world data support Elecsys pTau217 as a standalone blood test, comparable to a PET scan, for rule-in and rule-out identification of amyloid pathology
Basel, 28 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its Alzheimer’s development portfolio is being presented at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer’s across the entire patient journey.
Featured oral presentations include the latest results from the ongoing Phase Ib/IIa Brainshuttle™ AD study, which continue to support rapid and robust reduction of amyloid plaques, and design of the Phase III TRONTIER 1 and 2 studies of investigational trontinemab for early symptomatic Alzheimer’s disease, with initiation planned later this year. As part of its growing Alzheimer’s development programme, Roche announced today its plans for an additional Phase III trial to investigate trontinemab in preclinical Alzheimer’s disease. The trial will focus on individuals at risk of cognitive decline, with the goal of potentially delaying or preventing the progression of the disease to 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, 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.”
Late-breaking oral and poster presentations highlight the potential of Roche’s Elecsys® pTau217 as a reliable and accessible blood-based biomarker test, providing comparable results to PET scan and cerebrospinal fluid (CSF) diagnostics for rule-in and rule-out diagnosis of amyloid pathology, a hallmark of Alzheimer’s disease, across care settings. The test, which received Breakthrough Device Designation from the U.S. Food and Drug Administration last year, will also be utilised in Roche’s TRONTIER studies.
“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.”
Up to
Pharmaceuticals
In a 90-minute Featured Research session, designs were shared for the Phase III studies, TRONTIER 1 and 2, which will initiate later this year, investigating the efficacy and safety of investigational trontinemab in people with early Alzheimer’s disease. The primary endpoint will measure the change in cognition and function based on the Clinical Dementia Rating – Sum of Boxes scale after 18 months of treatment. Secondary endpoints will include assessments of cognition, function, behavioural symptoms, and quality of life. A pre-screening study, TRAVELLER, based on a brief clinical assessment and a plasma biomarker, which will be identified using the Elecsys pTau217 test, has also been initiated, to enable broader community outreach and extend access to these trials to more diverse populations representative of Alzheimer’s disease.
New data on the latest results for trontinemab from the completed dose-expansion part of the 1.8 mg/kg and 3.6 mg/kg cohorts from the ongoing Phase Ib/IIa Brainshuttle AD study continued to show rapid and robust reduction of amyloid plaques in the brain as measured by amyloid positron emission tomography (PET). In the 3.6 mg/kg cohort, trontinemab reduced amyloid levels below the 24 centiloid positivity threshold in
These data were reinforced by early and significant reductions in fluid biomarkers of Alzheimer’s disease, including total tau, phosphorylated Tau (pTau)181, pTau217, and neurogranin measured in CSF and plasma.Trontinemab continues to show a favourable safety and tolerability profile. Amyloid-related imaging abnormalities-edema/effusion (ARIA-E) continued to be observed in <
Diagnostics
Roche will present data on a new study comparing the pTau217/Ab42 plasma ratio to the high-throughput, fully automated Elecsys pTau217 assay. The presentation will report on the accuracy of these tools in detecting amyloid pathology. Together with the high throughput and full automation of the assay, these data will assess the potential of Elecsys pTau217 as an accurate standalone rule-in and rule-out test that could be scaled up for broad implementation in routine clinical practice worldwide.
Additionally, results from a cohort-based model of healthcare utilisation in the U.S. demonstrated that using the Elecsys® pTau181 blood-based rule-out test in primary care scenarios improved diagnostic accuracy and reduced resource use compared with the current standard-of-care clinical, cognitive and imaging tests. If made available in primary care settings, the Roche Elecsys® pTau181 blood test has the potential to reliably avoid the need for further confirmatory testing in nearly all people who receive a negative result. This will avoid the need for these people to undergo unnecessary testing using CSF or PET, which often come with long wait times and high cost, resulting in further delays to diagnosis and cost to healthcare systems.
| Medicine | Abstract title | Presentation number (type) Presentation date (session) Time |
| Abstracts will be available on the AAIC website. | ||
| Pharmaceuticals | Next wave of innovation in Alzheimer’s disease therapeutics: The value of novel active transport mechanisms | Featured Research Session (FRS), Talk 1 Room 718 27 Jul 2025, 2pm - 3.30pm EDT Cath Mummery, Roberto Villaseñor, Jens Niewoehner, Scarlett Barker, Luka Kulic |
| Latest results from the dose-expansion part (Part 2) of the Brainshuttle™ AD study of trontinemab in people with Alzheimer’s disease | Featured Research Session (FRS), Talk 2 Room 718 27 Jul 2025, 2pm - 3.30pm EDT Luka Kulic, Fabien Alcaraz, Gregory Klein, Stephen Salloway, Carsten Hofmann, João A. Abrantes, Stella Yilmaz, Denise Sickert, Maddalena Marchesi, Jakub Wojtowicz, Andres Schneider, Ruth Croney, David Agnew, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel | |
| Interim biomarker results for trontinemab, a novel Brainshuttle™ antibody in development for the treatment of Alzheimer’s disease | Featured Research Session (FRS), Talk 3 Room 718 27 Jul 2025, 2pm - 3.30pm EDT Gregory Klein, Gil Rabinovici, Henrik Zetterberg, Matteo Tonietto, Tobias Bittner, Daria Rukina, Fabien Alcaraz, Carsten Hofmann, Maddalena Marchesi, Jakub Wojtowicz, Ruth Croney, David Agnew, João A. Abrantes, Franziska Schaedeli Stark, Silke Ahlers, Paul Delmar, Hanno Svoboda, Iris Wiesel, Luka Kulic | |
| TRONTIER 1 and TRONTIER 2: Pivotal trials of trontinemab in early symptomatic Alzheimer’s disease | Featured Research Session (FRS), Talk 4 Room 718 27 Jul 2025, 2pm - 3.30pm EDT Janice Smith, Catherine Mummery, Jeffrey L. Cummings, Gil Rabinovici, Stephen Salloway, Reisa Sperling, Henrik Zetterberg, Angeliki Thanasopolou, Christopher Lane, Paul Delmar, Gregory Klein, Ruth Croney, Jakub Wojtowicz, Carsten Hofmann, Luka Kulic, Hideki Garren | |
| Diagnostics | Evaluating the Impact on Diagnostic Performance and Healthcare Resource Utilization of Introducing a plasma rule-out test in the Alzheimer's Disease Diagnostic Pathway | Poster #102729 July 27, 7:30am- 4:15pm EDT Sophie Roth, Gustaf Ortsäter, Joana Amorim Freire Location tbc |
| Evaluating the Clinical Performance of the Elecsys pTau217 Plasma Immunoassay to Detect Amyloid Pathology in a Routine Clinical Practice Cohort | Poster #96679 July 28, 7:30 am – 4:15 pm EDT Sayuri Hortsch, Niels Borlinghaus, Alexander Jethwa, David Caley, Annunziata Di Domenico, Craig Ritchie | |
| Clinical performance and effect of pre-analytical variation of plasma pTau217 alone versus the plasma pTau217/Aβ42 ratio for the identification of amyloid pathology | Oral Developing Topics #108585 3-23-DEV Developing Topics on Tau Biomarkers July 29, 2025: 2:00 PM – 3:30 PM Christopher M. Rank, Joana Amorim Freire, Alexander Jethwa, Annunziata Di Domenico, Christina Rabe, Marc Suárez-Calvet, Colin L. Masters, Tobias Bittner | |
| Accuracy of cerebrospinal fluid biomarker ratios to determine amyloid positron-emission tomography status: a diagnostic test accuracy meta-analysis | Poster #100941 July 28, 7:30 am – 4:15 pm EDT Pablo Martinez-Lage, Eino Solje, Julian G. Martins, Sraboni Sarkar | |
| Equity in diagnosis through adequate clinical trial design in diagnostic performance studies | Poster #102804 July 30, 7:30am-4:15pm EDT Imke Kirste, David Caley, Clara Quijano Rubio, Margherita Carboni | |
| Investigating Differences in Patients Enrolled in a Clinical Study Based on Referral Type | Poster #108110 July 30, 7:30am-4:15pm EDT Sophie Roth, Laura Schlieker, Sayuri Hortsch, Joana Amorim Freire,David Caley | |
About trontinemab
Trontinemab is an investigational Brainshuttle bispecific 2+1 amyloid-beta targeting monoclonal antibody specifically engineered for enhanced access to the brain to enable rapid reduction of amyloid in people with Alzheimer's disease. Trontinemab is designed for the efficient transport across the blood-brain barrier to target aggregated forms of amyloid beta and remove amyloid plaques in the brain.
The uniqueness of trontinemab is based on Roche's proprietary Brainshuttle technology combining an amyloid beta-binding antibody with a transferring receptor (TfR1) shuttle module. As a result, high central nervous system (CNS) exposure of trontinemab may be achieved at low doses, leading to a rapid and deep amyloid clearance. Due to its unique properties, trontinemab might unlock the full potential of disease-modifying monoclonal antibodies by effectively penetrating the brain and potentially leading to slowing of disease progression.
About Roche in Alzheimer’s Disease
With more than two decades of scientific research in Alzheimer’s disease, Roche is working towards a day when we can detect and treat the disease early, in order to slow down, stop or even prevent its progression to preserve what makes people who they are. Today, the company’s Alzheimer’s disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer’s disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer’s community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] https://publichealth.jhu.edu/2002/alzheimer-age
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FAQ
What are the key results of Roche's trontinemab Phase Ib/IIa trial for Alzheimer's disease?
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What is the current state of Alzheimer's disease diagnosis globally according to Roche?
What is the primary endpoint for Roche's TRONTIER 1 and 2 Phase III studies?
