Clinical Trials

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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