On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt) for the treatment of early symptomatic Alzheimer's disease. This groundbreaking development brings new hope to millions affected by this devastating condition.

A Milestone in Alzheimer's Research

Donanemab, developed by Eli Lilly and Company, is an investigational antibody therapy that targets and removes amyloid plaques in the brain, which are believed to contribute to the progression of Alzheimer's disease. The Memory and Aging Program at Butler Hospital played a crucial role as one of the lead sites for the TRAILBLAZER-ALZ Phase 2 trial that led to this approval.

Promising Results

The FDA's decision was based on the results of clinical trials, including the TRAILBLAZER-ALZ 2 Phase 3 study. Key findings include:

• Donanemab slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in participants with early symptomatic Alzheimer's disease.
• The drug reduced participants' risk of progressing to the next clinical stage of disease by up to 39%.
• Donanemab significantly reduced amyloid plaques, with an average reduction of 84% compared to the start of the study after 18 months of treatment.

Innovative Treatment Approach

Donanemab is the first and only amyloid plaque-targeting therapy that uses a limited-duration treatment regimen based on amyloid plaque removal. This approach could result in fewer infusions and lower treatment costs for patients.

"As we celebrate this significant step forward, the Memory and Aging Program remains committed to advancing research and clinical trials that bring us closer to more effective treatments and, ultimately, a cure for Alzheimer's,” said Edward Huey, M.D., director of the Memory and Aging Program. “We are proud to have played a role in the TRAILBLAZER-ALZ study and look forward to continuing our collaboration with leading institutions and pharmaceutical companies to improve the lives of those affected by this disease."

Stephen Salloway, M.D., M.S., Professor of Neurology and Psychiatry at the Alpert Medical School of Brown University and Founder of the Memory and Aging Program, added:

"The FDA approval of donanemab represents a landmark moment in the treatment of Alzheimer's disease. For the first time, we have medications that target and remove a core pathology of Alzheimer's disease and that promote independence and quality of life for patients. We extend our deepest gratitude to the patients, families, and caregivers who participated in the clinical trials, as well as to our dedicated research team. Your contributions have been instrumental in bringing this new treatment option to those who need it most.”

For more information about donanemab or to learn about ongoing clinical trials at the Memory and Aging Program, visit butler.org/memory or call (401) 455-6402.