Roche reports positive Phase results: trontinemab
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Roche reported positive Phase 3 results for trontinemab in early symptomatic Alzheimer's disease. ClinicalTrials.gov shows two recruiting Phase 3 studies and one earlier Phase 1/2 Brainshuttle AD study.
Roche reports positive Phase results for trontinemab from the Phase Ib/IIa Brainshuttle AD study—not a completed Phase 3 efficacy readout. At 3.6 mg/kg, 91% of participants reached amyloid PET negativity by week 28, while Phase 3 TRONTIER trials in early symptomatic Alzheimer’s disease are still recruiting.
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Key Takeaways
- Positive public data are Phase Ib/IIa Brainshuttle AD (NCT04639050), not final Phase 3 clinical outcomes.
- At 3.6 mg/kg, 91% (49/54) were below 24 centiloids on amyloid PET after 28 weeks; 72% (39/54) were below 11 centiloids.
- ARIA-E stayed under 5% (4/149) across 1.8 and 3.6 mg/kg cohorts in blinded safety data Roche cited at AAIC 2025.
- Phase 3 TRONTIER 1 (NCT07169578) and TRONTIER 2 started in 2025 and remain recruiting, with primary completion estimated in 2028.
What Phase results has Roche actually reported?
In a July 28, 2025 media release, Roche said the completed dose-expansion cohorts of Brainshuttle AD continued to show rapid amyloid plaque reduction on PET. That is the sourced “positive Phase” package BD teams should cite today.
Read the company notice: Roche AAIC 2025 Alzheimer’s update. Do not treat recruiting Phase 3 studies as completed efficacy trials.
How strong was amyloid clearance in Brainshuttle AD?
In the 3.6 mg/kg cohort, trontinemab reduced amyloid below the 24-centiloid positivity cut-off in 91% of participants (n=49/54) after 28 weeks. Deep clearance below 11 centiloids occurred in 72% (n=39/54).
ARIA-E was reported in under 5% of participants (blinded; N=4/149 across the 1.8 and 3.6 mg/kg cohorts). Those figures are biomarker and safety signals, not proof that cognition or function improved in Phase 3.
Where are the Phase 3 TRONTIER studies today?
TRONTIER 1 (NCT07169578) is recruiting. ClinicalTrials.gov lists Hoffmann-La Roche as sponsor, Phase 3, about 800 estimated participants, start date September 17, 2025, and primary completion estimated June 7, 2028.
- Population: early symptomatic Alzheimer’s (MCI to mild dementia due to AD).
- Primary endpoint: change from baseline to Week 72 in CDR-SB.
- A twin Phase 3 study, NCT07170150, is also recruiting under the same sponsor.
Earlier Brainshuttle AD work is registered as NCT04639050 (Phase 1/2; active, not recruiting; 241 participants).
What Roche said next at AAIC 2026
On July 7, 2026, Roche previewed long-term open-label extension data from Brainshuttle AD and the design of PrevenTRON, a planned Phase 3 study in preclinical Alzheimer’s. Modelling from the early study informed dosing for ongoing TRONTIER 1 and 2.
Source: Roche AAIC 2026 portfolio update. That release still does not publish a completed Phase 3 efficacy table for early symptomatic disease.
What remains unproven
No peer-reviewed Phase 3 CDR-SB win is available for trontinemab. Amyloid PET clearance and low ARIA-E in Phase Ib/IIa do not equal clinical benefit. Regulatory approval status remains investigational. Any headline that says “positive Phase 3 results” without a completed primary analysis overstates the public record.
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Frequently Asked Questions
Did Roche report positive Phase 3 results for trontinemab?
No final Phase 3 efficacy readout is public. Roche reports positive Phase Ib/IIa Brainshuttle AD biomarker results. Phase 3 TRONTIER 1 (NCT07169578) and TRONTIER 2 (NCT07170150) are recruiting, with primary completion estimated in 2028.
What Phase Ib/IIa amyloid results did Roche report?
In the 3.6 mg/kg cohort of Brainshuttle AD, 91% of participants (49 of 54) fell below the 24-centiloid amyloid PET positivity threshold after 28 weeks; 72% (39 of 54) reached deep clearance below 11 centiloids. ARIA-E remained under 5% across the 1.8 and 3.6 mg/kg cohorts (4 of 149, blinded).
What are the Phase 3 TRONTIER trials testing?
TRONTIER 1 (NCT07169578) is a Roche-sponsored Phase 3 study in early symptomatic Alzheimer’s disease (MCI to mild dementia), with about 800 planned participants and a primary endpoint of change in CDR-SB to Week 72. Primary completion is estimated for June 7, 2028.
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