NEW ALZHEIMER'S DRUG APPROVED!

Charter Research contributes data toward FDA approval of donanemab.

SEE THE STORY

New Medication Approved

Local study participants at Charter Research contribute to Leqembi (lecanemab) approval.

Gordon's Leqembi Story

With a history of dementia in his family, Gordon Van Slyke decided to enroll in the lecanemab study at Charter.

Led by Dr. Norton, the Charter team worked with patients like Gordon for 4 years as part of a global effort to validate the efficacy of this groundbreaking, new drug.

About

It began when Gordon Van Slyke realized he could no longer remember each and every hole on many of the 50 sprawling golf courses in The Villages. This would be an extraordinary feat for most people, but for Gordon—an avid golfer who prides himself on memorizing not only every hole but also the precision of each shot that goes with his game—it was his norm.

“It was the first serious warning sign,” he said. With a strong familial link to the disease—both his mom and sister died of Alzheimer’s while in their sixties—Gordon knew what could happen. He saw his doctor and was soon diagnosed with early stage Alzheimer’s disease.

Then Gordon saw an ad for a clinical trial of a new investigational medication called lecanemab. Dr. Jeffrey Norton at Charter Research in The Villages was overseeing the trial, and the medication might potentially change the course of the disease.

Gordon enrolled in the trial and began visiting Charter Research every two weeks, providing urine and blood samples and receiving an infusion—either of the medication or a placebo (it was a blinded study). Turns out, the medication worked, and Gordon’s participation in the trial helped contribute clinical data that the FDA used to approve lecanemab (now marketed by Eisai as Leqembi).

“I’m happy to have participated. I was all-in, whatever needed to be done, to try anything. We’re thankful that Charter Research is in our life.”

Local volunteers like Gordon are the backbone of clinical research; they’re the people who make a difference in helping to advance medicine. And some of the trial participants like Gordon received lecanemab for years before it was available to the public.

Study participants bring hope to themselves and to the world.

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2023
Swedish biotech company BioArctic develops lecanemab. Lecanemab is designed to remove amyloid beta, a protein that accumulates in the brain during the progression of Alzheimer’s disease.
BioArctic partners with pharmaceutical companies Eisai and Biogen to further develop lecanemab.
First clinical trials of lecanemab begin.
Eisai begins “Clarity AD,” the large Phase 3 study that will ultimately lead to FDA approval of lecanemab.
Eisai announces positive results from ongoing Phase 3 clinical trial of lecanemab. The trial shows that lecanemab is effective in slowing the decline of cognitive function in people with Alzheimer's disease.
FDA grants accelerated approval for lecanemab.
FDA converts lecanemab’s accelerated approval to traditional approval. Medicare announces that it will cover Leqembi (the marketing name for lecanemab) at 80%.

Clinical Trial Sponsor

Studies like this show the necessity for getting tested and—if needed—to begin preserving what you have, through lifestyle changes and medical interventions.

Dr. Norton Medical Director

I have the legacy of family with my kids and grandkids. My genes are part of them, so I owe it to them to help find a cure.

Gordon Van Slyke Clinical Trial Participant

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