Sentara neurology team participates in clinical trial leading to FDA drug approval for early Alzheimer’s disease

Daniel Cohen, M.D., clinical chief of neurology at Sentara Health, said he’s participated in many clinical trials throughout his 13 years at the health system, but this is the first time the neurology team has been involved in a clinical trial that has shown enough promise to lead to approval by The Food and Drug Administration (FDA).

The Trailblazer clinical trial began in 2020 and studies the safety and effectiveness of donanemab in patients with early Alzheimer’s disease. Sentara is one of just 275 locations in the world to be enrolled in the study.

Alzheimer’s disease is the most common cause of dementia. It is an irreversible, progressive brain disorder that slowly erodes memory and thinking skills. According to the Alzheimer's Association, nearly seven million Americans are living with Alzheimer’s, and it kills more people than breast cancer and prostate cancer combined.

The recently approved drug, donanemab, was shown to slow the progression of Alzheimer’s when given in early stages of the disease. It carries safety risks including swelling and bleeding in the brain, so potential patients undergo comprehensive safety screenings to ensure the medication is appropriate for their use.

With the approval of this drug, there will soon be two prescription drug choices for people suffering from early Alzheimer’s disease. Lecanemab is a similar drug that was approved just last year.

“Until recently, our treatment options for Alzheimer's disease treated symptoms of the illness, but we did not have treatments to slow down the disease process itself,” said Dr. Daniel Cohen. “Donanemab and lecanemab target a specific aspect of the biology of Alzheimer’s disease, that is removing abnormal amyloid protein deposits in the brain, slowing the process and reducing the amount someone may decline over the next several years.”

“This study was extremely involved, for both the hospital and the participants,” said Kate Mitchell, RN, clinical research educator at Sentara. “Our participants and their family members came for monthly visits for three years.   Some visits took 3-5 days and included multiple sets of brain imaging, EKG, labs, hours of neurocognitive testing, and finally infusion. The participants and their families showed incredible commitment, attending visits consistently despite everything else going on in their lives.”

“The teams were amazing,” Mitchell added. “Sentara Research, Sentara Medical Group neurology, PET, MRI, Pharmacy, Infusion Center, and more worked together to make this happen. It takes intensive coordination between departments to make certain everything is completed correctly and on time.”

The drug is intended for people who have noticeable memory loss or problems with other thinking skills that are clearly abnormal for their age but who are still functionally independent or require minimal daily assistance.

“When there is clinical suspicion, we now have several tests, which we refer to as biomarkers, that can give us much more confidence as to whether or not those cognitive changes are due to Alzheimer’s disease,” Dr. Cohen said. “Because the current treatments only work early in the disease process when it is still mild, it’s so important for patients to have annual primary care visits and to share all concerns or health changes with their care teams.”

The Sentara neurology team is working to share education on the growing treatment opportunities for Alzheimer’s disease with Sentara Medical Group providers and other community healthcare partners.

Participating in this clinical trial was coordinated through the Sentara Health Research Center. Sentara is currently enrolled in more than 150 active clinical trials to advance health care through the communities we serve.