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Blood-based Alzheimer's Disease Biomarkers in Patients Undergoing Lecanemab Treatment

Overview

Información sobre este estudio

The overall aim of this study is to evaluate the performance of blood-based biomarkers of Alzheimer's Disease (AD) in patients undergoing Lecanemab treatment at Mayo Clinic Rochester.  

Specific Aims:

  • Evaluate the use of the plasma AD biomarkers: plasma amyloid beta 42/40 ratio (Abeta42/40) and phosphorylated Tau (pTau) to detect amyloid pathology in patients enrolled in Lecanemab infusion treatment (baseline measurement). In this aim the performance of these biomarkers to identify patients with a positive amyloid-PET or positive CSF biomarkers will be assessed.
  • Evaluate changes in plasma AD biomarkers: plasma Abeta42/40 and pTau in patients enrolled in Lecanemab infusion treatment.  In this aim the blood biomarker concentrations will be evaluated longitudinally (baseline and then 3, 6, 12, 18 and 24 months after treatment initiation). The goal is to assess if changes in blood-based biomarkers correlate with treatment associated changes in clinical measures such as cognitive test scores, MRI and PET imaging and AD CSF biomarker measurements associated with amyloid pathology.
  • Evaluate if changes in plasma biomarkers such as neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) may be predictors of amyloid-related imaging abnormalities (ARIA) in patients enrolled in Lecanemab infusion treatments.  In this aim, these blood biomarker concentrations will be evaluated longitudinal (baseline and then 3, 6, 12, 18 and 24 months after treatment initiation) to assess if changes in blood-based biomarkers correlate with development of ARIA or other complications.  Additionally, these markers are associated with changes in amyloid pathology and will also be examined for correlation with Abeta42/40 and pTau blood-based biomarkers over the course of the study.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Patients that are enrolling on Lecanumab infusion treatment.

Exclusion Criteria:

  • Patient not enrolled in Lecanumab infusion treatment.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/12/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Alicia Algeciras-Schimnich, Ph.D.

Abierto para la inscripción

Contact information:

Jenna Capelle

(507) 266-5017

Capelle.Jenna@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20557664

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