PORTLAND, Ore. — A potentially groundbreaking clinical trial that can slow or stop the earliest brain changes due to Alzheimer's disease in people is happening right now at Oregon Health & Science University in Portland.
“It’s the only way that breakthroughs can be made in Alzheimer’s prevention,’ OHSU Associate Professor of Neurology Aimee Pierce M.D. said.
OHSU is at the frontlines of a new drug trial aimed at preventing Alzheimer’s disease and they’re looking for more people to sign up to be a research volunteer.
The AHEAD Study is an international clinical trial that looks at the treatment of a drug called Lecanemab to delay memory decline in people up to 20 years before the symptoms of Alzheimer’s disease appear.
Barbara Klausman makes her way from Vancouver to Portland every two weeks to participate as a volunteer in the study.
“I have Alzheimer’s in my family. My mother, I went through that with her, and it just made me realize what an awful disease it is and hope for a cure,” she said. “I’m hoping that my daughters, who are in their 50s will never have to worry about it. That’s my ultimate goal.”
Each visit she gets an infusion, but she doesn’t know if she’s getting the drug or a placebo.
“That is the gold standard for research is to do placebo-controlled double-blind study in order to determine if the study drug works,” said Pierce, who's also a researcher in the AHEAD Study.
“We hope, and we’re testing in this study, if we can identify these changes in the brain before there are any symptoms and intervene — we’ll find a way to prevent Alzheimer’s disease from even developing in older adults,” Pierce said.
The study enrolls healthy 55 to 80-year-old adults who are thought to be at increased risk for brain changes and memory loss associated with Alzheimer’s disease.
Lecanemab may slow or remove the buildup of a protein known as amyloid that forms plaques in the brain. Researchers believe that build-up may play a key role in the development of Alzheimer’s disease symptoms like memory loss and problem thinking.
“We know that amyloid plaque can develop many, many years before symptoms. Sometimes ten or 15 years before symptoms,” Pierce said.
The AHEAD Study tests the drug Lecanemab in people with evidence of the amyloid build-up in their brain, but who do not show symptoms of Alzheimer’s disease.
“It’s [Lecanemab] an antibody against amyloid fibrils and these are abnormal proteins, which are accumulating in the brain,” Pierce said. “And the study drug binds to those and activates your own immune system to clear the amyloid fibrils from the brain.”
Pierce is hopeful about this study and the potential of the drug.
Earlier this month, the FDA granted accelerated approval to Lecanemab for people already in the early stages of Alzheimer’s disease.
Through the AHEAD study, discovering a treatment that targets brain changes early means doctors may be able to one day prevent memory loss.
“It’s incredibly meaningful and exciting,” Pierce said.
The work being done in the study and the scientific progress it could make, wouldn’t be possible without volunteers like Kalusman.
“It is time-consuming. There’s no doubt about that, but I’m retired, and I have the time. So, I just felt I needed to do it,” Klausman said.
She’ll receive these infusions for four years in total. A commitment that she hopes leads to the approval of a drug that helps prevent Alzheimer’s.
“I hope that there will not be any Alzheimer’s in the future,” she said, “That it will be caught in time and that nobody will have to suffer from it, either the person or their families.”
For more information on the AHEAD Study or to sign up to become a research volunteer, click here.
For more clinical trials going on right now at OHSU, click here.
All clinical trials at OHSU: https://www.ohsu.edu/health/clinical-trials