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Desarrollo de fármacos

Marwan N Sabbagh1, Stephen Macfarlane2, Audrey Gabelle3

  • 1Barrow Neurological Institute, Phoenix, AZ, USA.

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

Blarcamesina, una molécula pequeña oral, muestra una eficacia significativa y un perfil de seguridad favorable para la enfermedad de Alzheimer temprana (EA). La iniciación temprana del tratamiento con blarcamesina (BLC) es crucial para obtener beneficios clínicos significativos en pacientes con EA.

Palabras clave:
BlarcamesinaEnfermedad de AlzheimerTratamiento oralNeurocienciaFarmacologíaGerontología

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Área de la Ciencia:

  • Neurociencia
  • Farmacología
  • Gerontología

Sus antecedentes:

  • No existen terapias modificadoras de la enfermedad de moléculas pequeñas orales aprobadas para la enfermedad de Alzheimer temprana (EA).
  • La blarcamesina (BLC) es una molécula pequeña oralmente biodisponible que mejora la autofagia mediante la activación de SIGMAR1, restaurando la homeostasis celular en la EA temprana.

Objetivo del estudio:

  • Evaluar la seguridad y eficacia de la blarcamesina oral (BLC) en la enfermedad de Alzheimer temprana (EA).
  • Evaluar los efectos a largo plazo de la iniciación temprana del tratamiento con blarcamesina (BLC).

Principales métodos:

  • El estudio ATTENTION-AD fue una extensión en abierto de un ensayo de Fase IIb/III que involucró a 508 participantes con EA temprana.
  • Se administró blarcamesina oral (BLC) una vez al día hasta por 144 semanas.
  • El análisis de inicio diferido evaluó los efectos del tratamiento hasta por 192 semanas.

Principales resultados:

  • La blarcamesina (BLC) demostró una buena eficacia y seguridad, con un evento adverso primario manejable y transitorio (mareo).
  • Un período de titulación más prolongado en ATTENTION-AD redujo significativamente la frecuencia de mareos en comparación con el estudio previo (9,6 % frente al 25,2 %).
  • El análisis de inicio diferido mostró mejoras cognitivas y funcionales significativas a las 192 semanas (ADAS-Cog13, ADCS-ADL), lo que resalta la importancia de la intervención temprana.

Conclusiones:

  • La blarcamesina (BLC) reduce significativamente el deterioro clínico, ofreciendo beneficios significativos para los pacientes con enfermedad de Alzheimer temprana (EA).
  • La blarcamesina (BLC) presenta un perfil de seguridad favorable, sin muertes relacionadas con el tratamiento ni eventos adversos de neuroimagen en 4 años.
  • La blarcamesina (BLC) representa una opción de tratamiento oral potencialmente eficaz, segura y escalable para la EA temprana.