Roche is eyeing a wider patient population for its anti-amyloid Alzheimer’s hopeful, trontinemab, as the space increasingly examines the potential of early treatment in boosting patient outcomes.
The Swiss pharma giant plans to do this through the PrevenTRON study it announced at the 2026 Alzheimer’s Association International Conference (AAIC) in London, which Roche’s trontinemab global development leader, Janice Smith, said is set to initiate within a few months.
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In this study, Roche will look how effective trontinemab may be in both asymptomatic and transitional patients displaying Alzheimer’s-related biomarkers.
To recruit for this study, Roche has harnessed its TRAVELLER registry, which is designed to reduce the screening burden for patients, while enhancing the company’s capacity to rapidly identify individuals that are eligible for treatment. By incorporating a consent form alongside a blood-based biomarker and cognitive test, Roche aims to allow patients to determine their eligibility without fully committing to a clinical trial.
Roche makes these moves as both Eli Lilly and Biogen & Eisai also explore the potential of their respective, approved anti-amyloid therapies Kisunla (donanemab) and Leqembi (lecanemab) in the preclinical population, as researchers theorise that targeting amyloid pathology earlier on could improve outcomes in Alzheimer’s disease.
Alongside the early treatment approach, researchers in the drug development space are also increasingly looking at preventative approaches to Alzheimer’s – with an example being cardiology biotech, NewAmsterdam. At AAIC 2026, the company presented Phase III data from the BROADWAY study (NCT05142722), which revealed that its LDL cholesterol-lowering drug, obicetrapib, significantly reduced the presence of key Alzheimer’s biomarker p-tau217 in patients with at least one copy of the APOE4 gene – highlighting its potential role in staving off disease progression in Alzheimer’s.
OLE data cements trontinemab’s Phase III development
Alongside the PrevenTRON announcement at AAIC 2026, Roche debuted new trontinemab efficacy and biomarker data from a portion of the open-label extension (OLE) segment of the Phase Ib/IIa Brainshuttle AD study (NCT04639050) – shining a spotlight on its potential to compete with approved anti-amyloid therapies like Kisunla and Leqembi.
At the conference, the company revealed that 92% of patients given the higher, 3.6mg/kg dose of trontinemab fell below the amyloid positivity threshold at 28 weeks – a feat that 65% of patients in the 1.8mg/kg group achieved.
Trontinemab was also found to provide continued amyloid reduction from baseline throughout the one-year OLE period, as measured by an amyloid PET scan.
In the presentation, Roche also touted the safety and tolerability profile of trontinemab, noting that infusion-related reactions (IRRs) – a common side effect of anti-amyloid therapies – occurred in seven (8.6%) of the 81 patients assigned to the trontinemab 12-weekly maintenance schedule. Anaemia cases were also low in this population, with three patients (3.7%) enduring this side effect up to the treatment cutoff.
Despite this, eight patients did experience brain microhaemorrhaging during the maintenance period, and there was a case of brain swelling linked to treatment. According to Jefferies analysts, this “poses a question on just how clean the safety profile [of trontinemab] actually is.” A male patient in the trontinemab treatment group also died two months after his last dose in the OLE portion of the trial, though Roche deemed this fatality, caused by a ruptured artery, unrelated to the study drug.
According to the Swiss pharma giant, these results support the induction and maintenance dosing regimens used in the Phase III TRONTIER 1 and 2 studies, which are currently ongoing.
If approved, trontinemab would become the third anti-amyloid therapy to reach the market – joining Eli Lilly’s Kisunla and Biogen & Eisai’s Leqembi on the market as their uptake in Alzheimer’s treatment grows. As per GlobalData’s Pharmaceutical Intelligence Center, Leqembi and Kisunla will join become blockbuster therapies in 2027 and 2028, respectively. However, they will need to navigate ongoing reimbursement challenges.
GlobalData is the parent company of Clinical Trials Arena.
