Donanemab exposure-response in early symptomatic Alzheimer's disease.

ABSTRACT:

Introduction

These analyses aimed to identify factors impacting donanemab exposure, amyloid plaque, and clinical efficacy in early symptomatic Alzheimer's disease using a population pharmacokinetic/pharmacodynamic (PK/PD) approach.

Methods

Analyses included donanemab trial participants (NCT02624778; NCT03367403; NCT04640077; NCT04437511). Dose- and exposure-response relationships were characterized relative to amyloid plaque lowering using indirect response PK/PD and disease progression models.

Results

Donanemab population PK was described by a biphasic distribution with an estimated terminal elimination half-life of approximately 12.1 days for a typical participant (72 kg body weight, 1:2560 maximum antidrug antibody [ADA] titer). Amyloid reduction was associated wit

SUBMITTER: Gueorguieva I 

PROVIDER: S-EPMC12265020 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature