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Desarrollo de Fármacos

Todd Feaster1, Prajakta Dinesh Mangeshkar2, Siew Tin Gan2

  • 1Acumen Pharmaceuticals, Inc, Newton, MA, USA.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
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Resumen

La detección de pTau217 en plasma identifica eficazmente a los participantes para ensayos de la enfermedad de Alzheimer (EA), reduciendo costos y carga para los participantes. Este método mejora la eficiencia del ensayo al seleccionar a personas con patología amiloide.

Palabras clave:
Enfermedad de AlzheimerpTau217ensayos clínicosbiomarcadoresdesarrollo de fármacosdeteccióncostoscarga del paciente

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Área de la Ciencia:

  • Neurología y Ensayos Clínicos; Descubrimiento y Validación de Biomarcadores

Sus antecedentes:

  • Los ensayos clínicos de la enfermedad de Alzheimer (EA) a menudo excluyen a personas que carecen de patología amiloide, lo que lleva a altas tasas de fracaso en la detección.; Estudios previos, como INTERCEPT-AD, mostraron fracasos significativos en la detección debido a escáneres PET de amiloide negativos.; Las concentraciones de pTau217 en plasma predicen de manera confiable la patología de la EA, ofreciendo una herramienta de detección potencial.

Objetivo del estudio:

  • Evaluar la utilidad de la medición de pTau217 en plasma en el estudio ALTITUDE-AD para enriquecer a los participantes con carga amiloide suficiente para ensayos tempranos de EA.; Evaluar el impacto de la detección de pTau217 en la reducción de costos y la carga para los participantes asociada con las pruebas confirmatorias de amiloide por PET o LCR.

Principales métodos:

  • ALTITUDE-AD (NCT06335173) es un estudio de Fase 2 que involucra a personas con EA temprana y patología amiloide.; La detección en sitios norteamericanos incluyó un proceso de dos partes: análisis de pTau217 en plasma (ensayo Lumipulse de Fujirebio) seguido de análisis confirmatorio de amiloide por PET o LCR Aβ42/40 para aquellos con pTau217 ≥0.15 pg/mL.; El análisis de costos comparó la estrategia de detección de dos partes con los costos proyectados sin el uso de pTau217.

Principales resultados:

  • El 48% de los participantes evaluados tuvieron pTau217 en plasma ≥0.15 pg/mL, calificando para pruebas confirmatorias.; El 81% de los participantes con pTau217 elevado cumplieron los criterios de elegibilidad de amiloide mediante PET o LCR.; La estrategia de detección de pTau217 redujo los costos totales de detección en aproximadamente 10 millones de dólares estadounidenses (40%) en sitios de EE. UU. y Canadá.

Conclusiones:

  • La detección de pTau217 en plasma enriquece eficazmente los ensayos clínicos tempranos de EA para participantes que cumplen los criterios de inclusión basados en amiloide.; Este enfoque reduce significativamente los costos de detección y minimiza los procedimientos invasivos como las punciones lumbares y la exposición a la radiación de las exploraciones PET para los participantes potenciales.