Donanemab (LY3002813) Phase 1b Study in Alzheimer's Disease: Rapid and Sustained Reduction of Brain Amyloid Measured by Florbetapir F18 Imaging.

ABSTRACT:

Background

Donanemab (LY3002813) is an IgG1 antibody directed at an N‑terminal pyroglutamate of amyloid beta epitope that is present only in brain amyloid plaques.

Objectives

To assess effects of donanemab on brain amyloid plaque load after single and multiple intravenous doses, as well as pharmacokinetics, safety/tolerability, and immunogenicity.

Design

Phase 1b, investigator- and patient-blind, randomized, placebo-controlled study.

Setting

Patients recruited at clinical research sites in the United States and Japan.

Participants

61 amyloid plaque-positive patients with mild cognitive impairment due to Alzheimer's disease and mild-to-moderate Alzheimer's disease dementia.

Intervention

Six cohorts were dosed with donanemab: single dose 10-, 20- or

SUBMITTER: Lowe SL 

PROVIDER: S-EPMC12280776 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature