Eli Lilly is in the final stages of testing its experimental anti-amyloid drug, donanemab. Charter Research will soon begin enrolling participants for testing if different doses of the drug can reduce the side effects.

Charter will be screening participants for the Phase 3 clinical trial of Eli Lilly’s drug donanemab. The trial will help determine the optimal dose for reducing the risk of amyloid-related imaging abnormality edemas (ARIA-E), a common side effect of anti-amyloid drugs. The study will take 1.5 years.

Donanemab was designed to remove toxic beta-amyloid plaques from the brain, which may prevent further damage and progression of Alzheimer’s disease. This mechanism is similar to Leqembi and Aduhelm, the only two FDA-approved anti-amyloid drugs for Alzheimer’s.

Based on data from previous trials, donanemab is effective in lowering the levels of beta-amyloid plaques in the brain. This forthcoming trial will help determine whether a lower dose of the drug would reduce the rates of adverse effects.

What to expect from the trial screening process

According to Alessandra Cuevas, a clinical research coordinator at Charter Research, Charter is currently recruiting participants aged 60 to 85 years of age who have experienced a slow progression of cognitive decline for at least six months and are willing to take a PET scan to confirm whether they have amyloid plaques in the brain. Individuals who have previously received anti-amyloid drugs are not eligible.

The screening process takes a total of 49 days, involving various health assessments, cognitive and physical assessments, and brain imaging.

What to expect from the donanemab trial

The trial will take about 1.5 years to complete involving a year of donanemab treatment. Depending on the dose that volunteers receive, they may be required to visit between one to two times per month. In addition, an extra visit will be required at the end of the study to measure the levels of beta-amyloid plaques at 78 weeks. Since this study is testing dosing, all participants will receive the active drug for up to 1.5 years.

What to know about anti-amyloid, antibody-based Alzheimer’s treatments like Donanemab

Today, nearly all existing treatments for Alzheimer’s are designed to help people manage symptoms, like memory loss — but they can’t cure Alzheimer’s, or prevent the disease from progressing.

Following Aduhelm, a new anti-amyloid drug by the same drugmakers, called Leqembi, has also received accelerated approval. Trial data showed that Leqembi slowed cognitive decline over the course of 18 months. Eli Lilly’s other anti-amyloid drug remternetug is also starting Phase 3 trials soon.

Ready to learn more?

Alessandra Cuevas at Charter Research in The Villages has been enrolling and screening potential trial participants. The principal investigator for the trial is Dr. Jeffrey A. Norton. You can call one of the two Charter locations to set up screening for trial eligibility:

  • The Villages: 352-441-2000
  • Orlando: 407-337-3000