New Medication Approved

Innovative trials in collaboration with Charter Research culminate in FDA approval of Kisunla (donanemab).

Disease impacted and desired effect:

Slowing cognitive decline by targeting & removing amyloid plaques.

Sherrie's Donanemab Story

With concerns about her memory loss, Sherrie Boyett enrolled in an Alzheimer's study at Charter Research.

Eighteen months later, Dr. Norton gave Sherrie the good news that she was amyloid plaque free—she no longer needed to receive the study medication.

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Donanemab success. Sherrie and Otto Boyett pose for a picture at the Charter Research offices. — Sherrie & Otto Boyett

About

When Sherrie Boyett received a diagnosis of Alzheimer’s disease, it was a scary time for her and her husband, Otto. “I was very concerned about not remembering names, even the people very close to me who I’d known for years,” she said. “I knew something was wrong.”

Referred to Charter Research by her doctor, Sherrie didn’t know what to expect. She’d never participated in a clinical trial before, but eagerly joined the study. “Charter reassured us and explained everything. Charter has helped us every step of the way,” explained Otto. Sherrie was one of 1,800 people to participate in the Phase 3 study for an investigational drug called donanemab.

18 months later—and two weeks before Christmas 2022—Dr. Jeffrey Norton, Charter’s lead physician on the study, informed Sherrie she was amyloid plaque free. Otto said, “We felt so grateful. This was the best Christmas of our lives! We are both so very thankful, and we couldn’t be happier with the care of Dr. Norton and the wonderful staff.”

At Charter Research, we partner with community members like Sherrie to test new investigational treatments. Our work brings improved medical understandings to the world and sometimes results in new FDA-approved treatments like donanemab (now marketed by Lilly as Kisunla).

You are the key—and the hope—to a healthier future. That’s why we commit to providing you an exceptional experience when you participate in a study.

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Eli Lilly licenses anti-amyloid beta (Aβ) plaque antibodies, developed under the guidance of Dr. David Holtzman, from Washington University.

Lilly begins developing the drug, known as donanemab.

Phase 1 clinical trials begin in the United States & Japan, with a total of 100 enrolled study patients.

Across 61 research facilities in the U.S. & Canada, Phase 2 clinical trials begin.

With 1,800 participants from eight countries in Asia, Europe, and North America, the Phase 3 study begins evaluating the safety and efficacy of donanemab in participants with early symptomatic AD.

Donanemab receives Breakthrough Therapy designation from the US Food & Drug Administration (FDA) to speed development and review.

Lilly presents full Phase 3 results, showing donanemab moderately slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease.

FDA grants traditional approval of donanemab, and Lilly begins marketing it under the name Kisunla.

Clinical Trial Sponsor

Why not get tested for memory loss? We do other things for our health, like wellness exams and blood tests. A memory screen can lead to an intervention that could help you preserve what you have.

Dr. Norton Medical Director, The Villages

The people I worked with were so good, so kind. They'll answer any questions you have, and I still miss a lot of those I worked with in the study. I feel like I've been blessed.

Sherrie Donanemab Study Participant