Trial to Test Antibody Drug for Alzheimer’s Prevention

(commonfund.nih.gov)

16 July 2021. Eli Lilly and Company is partnering with an Alzheimer’s disease research center to test a synthetic antibody for preventing the disorder in at-risk individuals. Banner Alzheimer’s Institute in Phoenix and the Indianapolis drug maker are planning a clinical trial to evaluate Eli Lilly’s experimental drug donanemab for preventing cognitive decline in people considered at high risk for developing Alzheimer’s disease.

Alzheimer’s disease is a progressive neurodegenerative condition, the most common form of dementia affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau. Alzheimer’s Disease International says an estimated 50 million people worldwide are living with dementia, a number expected to grow to 152 million by 2050.

Donanemab is a synthetic antibody designed to clear existing amyloid-beta protein plaques, while according to AlzForum most other drugs targeting amyloid-beta aim to prevent further amyloid-beta plaque deposits. Eli Lilly designed donanemab to slow progression of Alzheimer’s disease among people in the early stages of the disease. In January, the company reported that a mid-stage clinical trial shows donanemab slows declines in cognition and day-to-day functioning more than a placebo in participants with early Alzheimer’s disease symptoms. A late-stage trial is enrolling 1,500 participants with early Alzheimer’s disease to assess donanemab against a placebo for slowing cognitive and functional decline.

Prevent progression before symptoms develop

Banner Alzheimer’s Institute and Eli Lilly plan a clinical trial to test donanemab for a somewhat different purpose: as a way to prevent Alzheimer’s disease among participants considered at high risk, but not yet showing symptoms of the disease. Mark Mintun, an Eli Lilly vice president, says in a company statement that the new trial, “will evaluate whether donanemab can prevent clinical progression in patients who have evidence of Alzheimer’s pathology, but don’t yet demonstrate clinical symptoms.”

Banner Institute provides care for patients with Alzheimer’s disease as well as conducting research. One of Banner Institute’s main projects is the Alzheimer’s Prevention Initiative that evaluates treatments designed to prevent the disorder among individuals with genetic markers associated with Alzheimer’s disease. Alzheimer’s Prevention Initiative includes a patient registry with some 359,000 individuals who take part in clinical trials. The project also has a genetic testing service called GeneMatch, where participants send in a cheek swab for genetic testing, and based on the results are assigned to take part in clinical trials testing preventive treatments for Alzheimer’s disease.

In the collaboration with Eli Lilly, Banner Institute will conduct a late-stage clinical trial using GeneMatch, where participants are tested for a specific mutation in the apolipoprotein E or APOE gene known as epsilon 4. The APOE4 variation is associated with a higher risk and earlier age onset of Alzheimer’s disease. Eli Lilly cites data showing a person with two copies of the APOE4 variation are at a risk of developing Alzheimer’s disease up to 12 times higher than other APOE variants, and more likely to have beta-amyloid accumulations. Enrollment in the trial is expected begin later this year.

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• Lilly Gains Neuro Disease Biotech in $1.36B Deal

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