LY3002813 is an investigational immunotherapy for Alzheimer’s disease being developed by Eli Lilly. It is an antibody designed to stimulate the patient’s immune system to attack and destroy proteins in the brain that are believed to cause the neurodegeneration seen in Alzheimer’s.

How LY3002813  works

The symptoms of Alzheimer’s disease are caused by the loss of connections between, and death of, brain cells. What causes these cells to die is not fully understood, but researchers think it may be the accumulation of certain proteins in the brain. One of these proteins is beta-amyloid. It can form clumps called “plaques” which may trigger inflammation, disrupt brain cell communication, and lead to cell death.

LY3002813 is a type of antibody. Antibodies are a type of protein, made by the immune system, that bind to an antigen, a foreign substance or disease-causing agent in the body. Sometimes antibodies can neutralize the antigen simply by binding to it. In other cases, this binding attracts other immune system cells that destroy the antigen.

Researchers designed LY3002813 to bind to a form of beta-amyloid protein that already has aggregated into plaques. A study using mice showed that LY3002813 stimulated the immune system to attack beta-amyloid plaques and clear them from the brain. It appeared LY3002813 was able to clear plaques without causing microhemorrhages, or bleeding, in the brain.

LY3002813 in clinical trials

A small Phase 1 clinical trial (NCT01837641) examined the safety, tolerability, and pharmacodynamics (how the body absorbs and processes the treatment) of LY3002813 in 100 patients with mild Alzheimer’s and healthy volunteers. The study was completed in 2016, but the results have not been published.

A larger Phase 1 clinical trial of LY3002813 (NCT02624778) is currently recruiting about 150 participants with mild-to-moderate Alzheimer’s disease who are 50 or older. Participants will receive either a placebo, a single, or multiple doses of LY3002813. Blood samples will be taken from participants to monitor their levels of LY3002813, as well as their immune system’s response to it. Participants also will undergo PET scans to allow researchers to visualize and monitor beta-amyloid plaques in their brains. The three-part study will continue for up to 72 weeks.

There also is a Phase 2 clinical trial (NCT03367403) of LY3002813 that is recruiting participants with early-stage Alzheimer’s disease in the U.S. and Canada. This trial will evaluate the safety, tolerability, and effectiveness of LY3002813 alone and in combination with LY3202626, a treatment that inhibits the production of beta-amyloid. Some participants will receive a placebo. Participants must be 60 to 85 years old with mild Alzheimer’s. Over the 18-month duration of the study, their cognitive function will be monitored using a variety of assessments and researchers will use PET and MRI scans to monitor beta-amyloid plaques and brain health.

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