K2 Med is recruiting for a new Phase 3 trial for Eli Lilly’s new Alzheimer’s drug donanemab.
By: Simon Spichak
K2 is screening possible trial participants for a Phase 3 clinical trial of an Alzheimer’s drug called donanemab. Donanemab is designed to target beta-amyloid plaques which clump in the brain and lead to inflammation that may ultimately drive the progression of Alzheimer’s disease.
Eli Lilly’s trial will test whether periodic infusions of the anti-amyloid drug donanemab could prevent or delay the onset of Alzheimer’s in a population of people at risk of developing the disease. The study will recruit 3,300 participants in total, assigning them to receive either a placebo or the drug infusion monthly for nine months. Researchers will check in with participants over the course of three and a half years to look for signs of the start of cognitive decline.
What to expect from the trial screening process
According to Jennifer West, an investigator at K2, they are currently recruiting individuals between the ages of 65 and 80. To assess the risk of Alzheimer’s, clinical staff will draw blood during the first visit to measure the levels of an Alzheimer’s biomarker protein that can be found in the blood, called pTau-217. Elevated levels of this protein are associated with amyloid plaques and tau pathology in the brain.
What to expect from the trial
An individual might qualify for the trial based on the amount of this protein found in their blood plasma. They’ll receive monthly doses of donanemab, or a placebo, via intravenous infusion for nine months. The researchers will also perform cognitive assessments for the years that follow, via a convenient online platform.
What to know about anti-amyloid antibody-based Alzheimer’s treatments
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. As the prevalence of the disease grows, disease-modifying drugs are a dire need.
Drugmakers are working to fill this gap. One approach is anti-amyloids, which target Alzheimer’s biomarker amyloid plaques in the brain based on the theory that reducing or eliminating these plaques can stop and possibly even reverse disease progression.
Donanemab, along with similar experimental drugs like lecanemab are progressing through the pipeline toward FDA approval. Phase 3 clinical trials are the final step in this process.
Ready to learn more?
The principal investigator for the trial is Dr. Brandon Lenox. Call K2 Med if you’re interested in participating: 407-500-K2K2 (5252).