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Desarrollo de Fármacos

Jorge J Llibre-Guerra1, Jin Zhou2, Lon S S Schneider3,4,5

  • 1Washington University School of Medicine, St. Louis, MO, USA.

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

Los datos basales del ensayo de la enfermedad de Alzheimer de herencia dominante (DIAD) muestran características similares entre los grupos sintomático y asintomático. Esto proporciona una base para evaluar la terapia anti-tau etalanetug en pacientes con DIAD.

Palabras clave:
Enfermedad de Alzheimer de herencia dominanteensayo clínicoterapia anti-taudatos basalescaracterísticas demográficas

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Área de la Ciencia:

  • Neurociencia
  • Genética
  • Ensayos Clínicos

Sus antecedentes:

  • La enfermedad de Alzheimer de herencia dominante (DIAD) es una forma rara de enfermedad de Alzheimer (EA) de inicio temprano (30-50 años) y con fisiopatología compartida con la EA esporádica.
  • La DIAD afecta aproximadamente al 1% de los casos de EA, pero ofrece información sobre posibles tratamientos para todas las formas de EA.
  • La Red de Estudios de Alzheimer de Herencia Dominante - Unidad de Ensayos (DIAN-TU) tiene como objetivo desarrollar tratamientos para la DIAD, potencialmente aplicables a poblaciones de EA más amplias.

Objetivo del estudio:

  • Describir las características basales de los participantes en el ensayo DIAN-TU-001 Tau NexGen.
  • Evaluar la seguridad, tolerabilidad y eficacia de la terapia anti-tau etalanetug en combinación con lecanemab para DIAD.
  • Evaluar el impacto de etalanetug en la progresión clínica/cognitiva y en los biomarcadores relacionados con la enfermedad en poblaciones DIAD sintomáticas y asintomáticas.

Principales métodos:

  • DIAN-TU-001 es un ensayo de plataforma multicéntrico, aleatorizado, doble ciego, controlado con placebo de fase II/III.
  • El ensayo utiliza puntos finales de biomarcadores, cognitivos y clínicos para evaluar terapias investigacionales en individuos con mutaciones causantes de EA.
  • Las características basales se resumieron descriptivamente para dos cohortes: participantes con DIAD sintomáticos (CDR=0,5-1) y asintomáticos (CDR=0).

Principales resultados:

  • Se evaluaron 243 participantes, y 197 fueron aleatorizados en el ensayo DIAN-TU-001 Tau NexGen (Cohorte 1: 97; Cohorte 2: 100).
  • Las características basales fueron similares entre los grupos sintomático (Cohorte 1) y asintomático (Cohorte 2), con variaciones esperadas en las puntuaciones cognitivas.
  • La edad media fue de 47,8 años (Cohorte 1) y 43,4 años (Cohorte 2); las puntuaciones medias de CDR-SB fueron 3,7 (Cohorte 1) y 0,1 (Cohorte 2).
  • La frecuencia de portadores de APOE4 y la prevalencia del tipo de gen PSEN1 fueron consistentes con las expectativas para la población DIAD.

Conclusiones:

  • Las características basales del ensayo DIAN-TU-001 Tau NexGen se alinean con los perfiles clínicos de DIAD asintomática y sintomática.
  • Los datos confirman la consistencia general entre las cohortes sintomática y asintomática, con diferencias notables en las evaluaciones clínicas y cognitivas.
  • Estos hallazgos establecen una base sólida para la evaluación continua de las terapias anti-tau en DIAD.