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Desarrollo de Fármacos

María Pascual-Lucas1, Ana María Lacosta2, María Montañés2

  • 1Araclon Biotech, Zaragoza, Zaragoza, Spain.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
Resumen
Este resumen es generado por máquina.

La vacuna ABvac40 redujo significativamente el deterioro cognitivo significativo en pacientes con enfermedad de Alzheimer (EA), especialmente en aquellos con placas amiloides. La vacuna mostró una mayor eficacia en pacientes con niveles más altos de anticuerpos, lo que sugiere un potencial para la modificación de la enfermedad.

Palabras clave:
Enfermedad de AlzheimerVacunas contra el AlzheimerDeterioro cognitivoAmiloideDesarrollo de fármacos

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Área de la Ciencia:

  • Neurología
  • Inmunología
  • Farmacología

Sus antecedentes:

  • La enfermedad de Alzheimer (EA) implica Aβ40, implicado en la deposición de amiloide en los vasos sanguíneos.
  • ABvac40 es una vacuna experimental dirigida a Aβ40 para el tratamiento de la EA.
  • Los ensayos de fase 2 indicaron que ABvac40 tiene un buen perfil de seguridad e inmunogenicidad.

Objetivo del estudio:

  • Evaluar la relevancia clínica de ABvac40 mediante la evaluación de cambios significativos dentro del paciente (MWPC) en pacientes con EA.
  • Analizar el impacto de ABvac40 en el deterioro cognitivo y la progresión de la enfermedad.

Principales métodos:

  • Un estudio aleatorizado, doble ciego, controlado con placebo de fase 2 (AB1601) incluyó a pacientes con deterioro cognitivo leve o EA muy leve.
  • El cambio significativo dentro del paciente (MWPC) se definió como una disminución de ≥3 puntos en el MMSE en dos visitas consecutivas durante 24 meses.
  • Se utilizaron modelos de riesgos proporcionales de Cox para evaluar el riesgo de MWPC, con estratificación por niveles de anticuerpos en LCR.

Principales resultados:

  • ABvac40 redujo significativamente el riesgo de MWPC en un 53% en comparación con el placebo (HR=0.47; P=0.012) en la población general.
  • En pacientes positivos para amiloide-PET, ABvac40 mostró un efecto más pronunciado, reduciendo el riesgo de MWPC en un 62% (HR=0.38; P=0.005).
  • Los pacientes con niveles más altos de anticuerpos en LCR después de la vacunación experimentaron una reducción del 81% en el riesgo de MWPC (HR=0.19; P=0.029).

Conclusiones:

  • ABvac40 reduce significativamente el deterioro cognitivo clínicamente significativo en la EA en etapa temprana, particularmente en individuos positivos para amiloide-PET.
  • Los efectos más fuertes se observaron en pacientes con los niveles más altos de anticuerpos, lo que sugiere una relación dosis-respuesta.
  • Se necesita más investigación para explorar el impacto de ABvac40 en la vasculatura cerebral y su papel en los beneficios cognitivos.