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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Desarrollo de Fármacos

Dagmar Jürgens1, Gerhard Tischler2, Alexander Brener2

  • 1Priavoid, Düsseldorf, NRW, Germany.

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

El estudio PRIMUS-AD está evaluando PRI-002, un nuevo fármaco peptídico, para determinar su seguridad y eficacia en pacientes con Enfermedad de Alzheimer (EA). Se anticipan resultados a mediados de 2026, ofreciendo potenciales nuevos beneficios terapéuticos.

Palabras clave:
Enfermedad de Alzheimerensayos clínicosPRI-002deterioro cognitivo levedemencia leveneurocienciafarmacología

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Área de la Ciencia:

  • Neurociencia
  • Farmacología
  • Ensayos Clínicos

Sus antecedentes:

  • PRI-002 es un péptido todo D-enantiomérico diseñado para descomponer los oligómeros tóxicos de beta-amiloide (Aβ) en monómeros inofensivos.
  • Se postula que reduce la neurotoxicidad y restaura la plasticidad sináptica en las etapas tempranas de la Enfermedad de Alzheimer (EA).
  • PRI-002 ha demostrado ser seguro y bien tolerado en estudios previos en voluntarios sanos y en pacientes con deterioro cognitivo leve (DCL) o EA leve.

Objetivo del estudio:

  • Evaluar la seguridad y eficacia de PRI-002 en pacientes diagnosticados con deterioro cognitivo leve o demencia leve debido a EA.
  • Evaluar el beneficio terapéutico de PRI-002 a través de un ensayo clínico aleatorizado, doble ciego y controlado con placebo.

Principales métodos:

  • El estudio PRImus-AD es un ensayo de Fase 2, aleatorizado, doble ciego y controlado con placebo que involucra a aproximadamente 300 pacientes en seis países europeos.
  • Los pacientes se estratifican por estado de la enfermedad (DCL o demencia leve) y estado de portador de APOE e4, y luego se aleatorizan (1:1:1) para recibir 300 mg de PRI-002, 600 mg de PRI-002 o placebo diariamente durante 48 a 96 semanas.
  • La confirmación de la patología de la EA se realiza mediante análisis de líquido cefalorraquídeo (LCR) o escáneres PET de Amiloide. El objetivo principal de eficacia es el cambio desde el valor basal en la Escala de Evaluación de la Demencia Clínica Suma de Casillas (CDR-SB) a la semana 48.

Principales resultados:

  • Se completó el cribado de 540 pacientes tres meses antes de lo previsto, con aproximadamente 300 pacientes elegibles incluidos en el estudio.
  • Un recálculo del tamaño de la muestra a doble ciego confirmó los números de inclusión iniciales.
  • Se realiza un seguimiento cercano de las ARIA (Reacciones Adversas a la Amiloide Internalizada) en los primeros 90 pacientes hasta la semana 24, a pesar de que no se espera que PRI-002 induzca ARIA.

Conclusiones:

  • El estudio de Fase 2 PRIMUS-AD tiene como objetivo incluir a unos 300 pacientes con DCL y demencia leve debido a EA.
  • El estudio determinará la seguridad y el beneficio terapéutico de PRI-002.
  • Se proyecta que los resultados del estudio estén disponibles a mediados de 2026.