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Desarrollo de Fármacos

Reisa A Sperling1, Rema Raman2

  • 1Center for Alzheimer Research and Treatment, Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.

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

La investigación sobre la prevención de la enfermedad de Alzheimer (EA) avanza hacia la prevención primaria dirigiéndose a la acumulación temprana de amiloide. Nuevos ensayos utilizan biomarcadores plasmáticos para identificar a personas en riesgo y acelerar el desarrollo de soluciones globales para la prevención de la EA.

Palabras clave:
Enfermedad de Alzheimerprevención primariabiomarcadores plasmáticosensayos clínicosdiseño de ensayossoluciones globales

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Área de la Ciencia:

  • Neurología
  • Investigación de biomarcadores
  • Diseño de ensayos clínicos

Sus antecedentes:

  • Los ensayos de prevención de la enfermedad de Alzheimer (EA) han cambiado hacia el objetivo de las etapas preclínicas.
  • Los ensayos de prevención secundaria están probando medicamentos para reducir la carga de amiloide en la EA sintomática.
  • El objetivo final es prevenir la acumulación inicial de patología de amiloide y tau para la prevención primaria de la EA.

Objetivo del estudio:

  • Avanzar en los ensayos de prevención primaria para la enfermedad de Alzheimer utilizando resultados de biomarcadores.
  • Validar puntos finales de biomarcadores para la prevención primaria vinculándolos a beneficios cognitivos y clínicos.
  • Explorar el potencial de los biomarcadores plasmáticos y los agentes terapéuticos novedosos para la prevención global de la EA.

Principales métodos:

  • Utilización de biomarcadores plasmáticos (edad, genotipo APOE, p-tau217, Abeta42/40) para identificar a individuos con probabilidad de acumular amiloide.
  • Análisis de datos longitudinales de estudios como AHEAD y LEARN para guiar el diseño de ensayos de prevención.
  • Inscripción de más de 1000 individuos en el Estudio de Extensión de Plasma de Alzheimer (APEX) con anomalías sutiles de biomarcadores plasmáticos para una evaluación adicional.

Principales resultados:

  • Los hallazgos de los estudios AHEAD y LEARN están informando los futuros diseños de ensayos de prevención.
  • El estudio APEX está inscribiendo a poblaciones diversas para evaluar biomarcadores de EA y otros factores que contribuyen al deterioro cognitivo.
  • Los biomarcadores plasmáticos muestran ser prometedores en la identificación de individuos para la futura acumulación de amiloide.

Conclusiones:

  • La optimización del diseño de ensayos clínicos es crucial para la prevención global del Alzheimer.
  • El establecimiento de grandes cohortes internacionales con datos de biomarcadores plasmáticos acelerará el desarrollo de soluciones de prevención.
  • Las colaboraciones globales son esenciales para avanzar en la accesibilidad de la prevención del Alzheimer.