How Zagotenemab works
Alzheimer’s disease is a neurodegenerative disorder characterized by a slow worsening of memory and cognitive function. The symptoms of the disease are caused by the death of nerve cells in the brain.
Tau is one of two proteins whose build-up in nerve cells is thought to drive the development and progression of Alzheimer’s disease.
Zagotenemab is an antibody designed to bind to and neutralize tau protein tangles, hopefully slowing or stopping the worsening of Alzheimer’s disease.
Zagotenemab in clinical trials
Eli Lilly conducted a study in rats and primates to evaluate zagotenemab’s pharmacokinetics (movement in the body) and specificity for tau protein. The study, published in July 2017 in Alzheimer’s & Dementia, showed that the antibody was able to be processed by both animal species, and that it had an affinity for tau.
Based on these results, Eli Lilly started a Phase 1 clinical trial (NCT02754830) of zagotenemab in 110 Alzheimer’s disease patients and healthy volunteers. Some of the participants had mild cognitive impairment. Others had mild to moderate cases of Alzheimer’s disease. The study’s main goals were to assess the therapy’s safety and tolerability in participants. Researchers administered it as a single dose, either by injection or infusion into a vein. The trial is completed but no results have been released.
Eli Lilly also recruited 24 participants with mild cognitive impairment or Alzheimer’s disease for another Phase 1 trial (NCT03019536). The goal is to assess the safety of repeated doses of zagotenemab given by injection for 25 weeks. A key measure will be the number of participants for whom treatment leads to one or more serious adverse events. Secondary outcomes include evaluating how the body processes the therapy. Recruitment has been completed but the trial is still active with an estimated completion date of June 2020.
Eli Lilly has also begun recruitment in the U.S., Canada, and Japan for a Phase 2 clinical trial (NCT03518073) of zagotenemab in patients with early symptomatic Alzheimer’s disease. The study will recruit an estimated 285 patients to investigate the safety and effectiveness of the treatment. Patients will receive one of two different doses of zagotenemab or a placebo. The researchers will record the patients’ scores on several different cognitive assessment scales in order to compare their mental decline from baseline levels at the beginning of the study. The trial is expected to be completed in October 2021.
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