Donanemab, an investigational antibody, showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease, according to a phase 2 trial by Eli Lilly and Company.
Researchers are evaluating the safety, tolerability, and efficacy of the antibody in the ongoing randomized, placebo-controlled, double-blind, multicenter study.
Donanemab, which targets a modified form of beta-amyloid called N3pG, slowed decline by 32% relative to placebo. It met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale. Treatment with donanemab has rapidly resulted in high levels of amyloid clearance, according to a statement from the company.
Donanemab did not reach nominal statistical significance on every secondary endpoint but, compared with the placebo, showed consistent improvements in all prespecified secondary endpoints measuring cognition and function, Lilly announced.
"The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer's disease," Lilly chief scientific officer Daniel Skovronsky, MD, PhD, said.
The study's full results will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal, the company said.
"These positive results give us hope for patients and their families," said Mark Mintun, MD, vice president of pain and neurodegeneration for Lilly. –Meagan Thistle