Blood-based pre-screening in the SKYLINE secondary prevention Ph3 gantenerumab study.

ABSTRACT:

Introduction

SKYLINE was a secondary prevention study that used blood-based biomarker (BBBM) pre-screening to screen out participants with a low likelihood of amyloid positivity by positron emission tomography (PET) or cerebrospinal fluid (CSF) testing.

Methods

This retrospective analysis used data from SKYLINE (ClinicalTrials.gov: NCT05256134; terminated prematurely) and the Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) study to compare predicted and actual clinical performance characteristics of various biomarker combinations using prototype Elecsys^® plasma immunoassays (Roche Diagnostics International Ltd, Rotkreuz, Switzerland).

Results

In >3500 participants screened in SKYLINE, tau phosphorylated at threonine 181 (pTau181) and apolipoprotein

SUBMITTER: Bauer A 

PROVIDER: S-EPMC12519518 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature