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Desarrollo de Fármacos

Luka Kulic1, Fabien Alcaraz2, Gregory Klein2

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

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 26, 2025
PubMed
Resumen
Este resumen es generado por máquina.

Trontinemab, un anticuerpo anti-amiloide, muestra una rápida reducción de placas amiloides en pacientes con enfermedad de Alzheimer (EA). El estudio Brainshuttle™ AD indica efectos prometedores en seguridad y biomarcadores con anomalías de imagen relacionadas con amiloide limitadas.

Palabras clave:
TrontinemabEnfermedad de AlzheimerPlacas amiloidesAnticuerpos monoclonalesEstudios clínicos

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Área de la Ciencia:

  • Neurociencia
  • Farmacología
  • Inmunología

Sus antecedentes:

  • Investigación de trontinemab, un anticuerpo anti-amiloide, en el estudio Brainshuttle™ AD de Fase Ib/IIa.
  • Enfoque en pacientes con deterioro cognitivo leve debido a la enfermedad de Alzheimer (EA) o EA de leve a moderada.

Objetivo del estudio:

  • Presentar los últimos resultados de seguridad, farmacocinética y farmacodinámica (PD).
  • Informar sobre la parte de expansión de dosis en curso (Parte 2) del estudio Brainshuttle™ AD.

Principales métodos:

  • Estudio de Fase Ib/IIa con escalada de dosis (Parte 1) y fases de expansión de dosis (Parte 2).
  • Participantes aleatorizados en cohortes de dosis secuenciales (0,2-3,6 mg/kg) con una proporción activa:placebo de 4:1.

Principales resultados:

  • Se observó una reducción dosis-dependiente de las placas amiloides mediante imágenes de PET amiloide.
  • Depleción rápida y robusta de placas amiloides a dosis más altas (1,8 y 3,6 mg/kg), con la mayoría de los pacientes volviéndose amiloides negativos.
  • Efectos tempranos y pronunciados sobre los biomarcadores posteriores en el líquido cefalorraquídeo y baja incidencia de ARIA.

Conclusiones:

  • El tratamiento con trontinemab demuestra efectos tempranos y pronunciados sobre los marcadores de la patofisiología de la EA.
  • Se observó una incidencia muy limitada de anomalías de imagen relacionadas con amiloide (ARIA).
  • Sugiere el potencial de trontinemab en el tratamiento de la enfermedad de Alzheimer.