drugset / Trial / NCT01837641

A Study of LY3002813 in Participants With Alzheimer's Disease

NCT01837641

Phase 1 Completed 63 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindBasic science

Summary

The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.

Timeline

Start
2013-05-03
Primary completion
2016-08-24
Completion
2016-08-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Donanemab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Donanemab Monoclonal antibody 1 mg/kg Intravenous
Subject Donanemab Monoclonal antibody 3 mg/kg Intravenous
Subject Donanemab Monoclonal antibody 10 mg/kg Intravenous

Indications