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Drug Development.

Gregory Klein1, Gil D Rabinovici2, Henrik Zetterberg3

  • 1F. Hoffmann-La Roche Ltd, Basel, Switzerland.

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|December 25, 2025
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Summary
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Trontinemab, an amyloid-targeting antibody, shows significant amyloid plaque reduction in Alzheimer's disease (AD) patients. This novel therapy demonstrates promising results in lowering key AD biomarkers.

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Area of Science:

  • Neurology
  • Immunology
  • Pharmacology

Background:

  • Trontinemab is a novel monoclonal antibody targeting amyloid plaques in the brain.
  • It utilizes the Brainshuttle™ platform for enhanced blood-brain barrier penetration via transferrin receptor 1.
  • The drug is under investigation for Alzheimer's disease (AD) in the Phase Ib/IIa Brainshuttle™ AD study.

Purpose of the Study:

  • To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of trontinemab.
  • To assess the dose-dependent effects of trontinemab on amyloid pathology and downstream biomarkers in AD patients.
  • To explore the potential of trontinemab as a therapeutic agent for Alzheimer's disease.

Main Methods:

  • A randomized, double-blind, placebo-controlled, multiple ascending dose study (NCT04639050).
  • Participants received intravenous trontinemab or placebo across four dose cohorts (0.2-3.6 mg/kg) every 4 weeks.
  • Biomarker assessments included amyloid PET, MRI, CSF, and plasma analyses.

Main Results:

  • Interim analysis showed dose-dependent reduction in amyloid plaques across all active doses.
  • The 3.6 mg/kg dose achieved significant amyloid depletion (-107 centiloids by 28 weeks).
  • Reductions in CSF biomarkers (total tau, p-tau181, neurogranin) were observed by Week 25.

Conclusions:

  • Trontinemab demonstrated rapid and deep amyloid reduction at 1.8 and 3.6 mg/kg doses within 28 weeks.
  • Preliminary results support trontinemab's potential as a novel Alzheimer's disease treatment.
  • Further biomarker data will inform the continued development of trontinemab.