Charter Research is recruiting for a new Phase 3 Alzheimer’s trial for Eli Lilly’s new anti-amyloid drug remternetug.
Charter Research recently became the first center to start screening patients for a Phase 3 clinical trial of a new Alzheimer’s drug called remternetug. Drugmaker Eli Lilly says it’s part of the next generation of anti-amyloids. Results from the trial, called TRAILRUNNER-ALZ-1, will shed light on whether that’s the case.
There are a couple treatments for Alzheimer’s on the market right now — but the vast majority of them are only designed to help people manage symptoms, like memory loss. They don’t address the disease’s root cause, which means they can’t reverse it, stop it, or even slow it down as it moves through the brain.
Remternetug is an experimental Alzheimer’s drug by Eli Lilly, addresses Alzheimer’s differently. It’s an antibody protein designed to target toxic amyloid plaques, linked to the onset of Alzheimer’s disease. The drug is designed to attach to a specific region of the toxic amyloid protein, attracting other immune cells that can clear the plaques.
Right now, Charter Research is currently recruiting patients for the Phase 3 trial of the drug, looking for participants with early symptoms of Alzheimer’s who also have amyloid plaques in their brains.
So, why are these amyloid plaques so key? Well, many researchers believe that clearing them from the brain could prevent further cognitive decline — and even halt the progression of the disease.
Sound familiar? Remternetug isn’t the first to try it. This plaque-busting approach is what Biogen’s anti-amyloid treatment Aduhelm, approved by the FDA last year, is designed to do as well. Some patients who took Aduhelm during the clinical trials reported that the periodic infusions of the drug seemed to provide relief from their symptoms — while brain scans showed the drug cleared the amyloid plaques from their brains.
However, the fundamentals of this approach, and amyloid’s role in Alzheimer’s, are still being studied, and when it comes to Aduhelm specifically, there is still a great deal of controversy over whether the drug is broadly effective or not. Consequently, the FDA required that the clinical trials continue, even after the drug hit the market. Currently, the drug is pricey and tough to find for anyone not involved in that ongoing trial. More recently, another drug developed by Roche called crenezumab failed to prevent cognitive decline in people with an early-onset form of Alzheimer’s. The Alzheimer’s community, however, isn’t ready to give up on the decades of research that point to amyloid proteins as a key player in Alzheimer’s. Eli Lilly hopes remternetug’s differences from its two predecessors will pave the way for its success.
One of the unique aspects of the trial is how the drug will be delivered. Trial participants will be randomized across two groups, where one will receive intravenous infusions, while the other group will receive injections just under the skin. This will give researchers new insight into whether one delivery method or another is more effective.
According to the team at Charter, the study will take two years and 22 visits to the clinic, during which trial participants will receive the drug or placebo to test whether the drug can promote the clearance of amyloid plaques in the brain.
Kisha Kaffenberger who works at the Lady Lake Charter facility 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:
Lady Lake / The Villages: 352-775-1000
Winter Park / Orlando: 407-337-1000
“The easiest way to get involved with the study is to schedule a memory screen,” Kaffenberger said. “They will be asked to provide the coordinators with a list of medications and medical history.”
This process can take two to three hours and subsequent visits will take between one and a half and two hours. Most of the people screened so far have qualified while the staff work to find those participants that don’t qualify another clinical trial for which they may be better suited.
To learn about clinical trials of new medications that aim to modify the pathology of Alzheimer's disease, call Charter Research at 407-337-1000 (Orlando) or 352-775-1000 (The Villages).