A Study of LY3303560 in Participants With Early Symptomatic Alzheimer's Disease

Phase 2 Completed 360 enrolled Eli Lilly and Company

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimer's Disease (AD).

Timeline

Start: 2018-04-30
Primary completion: 2021-08-23
Completion: 2021-10-25

Outcome

Missed primary endpoint

paper In participants with early symptomatic AD, zagotenemab failed to achieve significant slowing of clinical disease progression compared with placebo. PMID 38386949 ↗

paper The mean disease progression ratio (proportional decline in the treated vs placebo group) with 95% credible intervals for the iADRS was 1.10 (0.959-1.265) for the zagotenemab low-dose group and 1.05 (0.907-1.209) for the high-dose, where a ratio less than 1 favors the treatment group. PMID 38386949 ↗

Publications

Fleisher AS, Munsie LM, Perahia DGS, Andersen SW, Higgins IA, Hauck PM, Lo AC, Sims JR, Brys M, Mintun M; PERISCOPE-ALZ Site Investigators. Assessment of Efficacy and Safety of Zagotenemab: Results From PERISCOPE-ALZ, a Phase 2 Study in Early Symptomatic Alzheimer Disease. Neurology. 2024 Mar 12;102(5):e208061. doi: 10.1212/WNL.0000000000208061. Epub 2024 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zagotenemab	Monoclonal antibody	1400 mg	Intravenous
Subject	Zagotenemab	Monoclonal antibody	5600 mg	Intravenous