Donanemab exposure and efficacy relationship using modeling in Alzheimer's disease.

ABSTRACT:

Introduction

Donanemab is an amyloid-targeting therapy that specifically targets brain amyloid plaques. The objective of these analyses was to characterize the relationship of donanemab exposure with plasma biomarkers and clinical efficacy through modeling.

Methods

Data for the analyses were from participants with Alzheimer's disease from the phase 1 and TRAILBLAZER-ALZ studies. Indirect-response models were used to fit plasma phosphorylated tau 217 (p-tau217) and plasma glial fibrillated acidic protein (GFAP) data over time. Disease-progression models were developed using pharmacokinetic/pharmacodynamic modeling.

Results

The plasma p-tau217 and plasma GFAP models adequately predicted the change over time, with donanemab resulting in decreased plasma p-tau217 and plas

SUBMITTER: Gueorguieva I 

PROVIDER: S-EPMC10301702 | biostudies-literature | 2023 Apr-Jun

REPOSITORIES: biostudies-literature