Second Drug Now Approved for Treating Alzheimer's Patients

Treatment options for patients with Alzheimer’s disease just took a big leap forward with the approval of a second drug, donanemab, that helps patients with early symptomatic Alzheimer’s disease maintain function and quality of life.

The U.S. Food and Drug Administration (FDA) granted full regulatory approval for donanemab, which can treat mild cognitive impairment and the mild dementia stage of Alzheimer’s disease. Last year, the FDA gave approval for lecanemab, a monoclonal antibody that targets beta-amyloid, a type of protein in the brain thought to be one of the underlying causes of Alzheimer’s disease.

Peter Gliebus, M.D., neurologist and director of cognitive and behavioral neurology for Marcus Neuroscience Institute at Boca Raton Regional Hospital, part of Baptist Health

“Although there is no cure for Alzheimer’s disease as of yet, donanemab is a disease-modifying therapy that has been shown to change trajectory or the progression of the disease,” says neurologist Peter Gliebus, M.D., director of cognitive and behavioral neurology for Marcus Neuroscience Institute at Boca Raton Regional Hospital, part of Baptist Health.

The antibodies in donanemab are administered monthly via infusion. “When infused, the antibodies reach the brain and attach to abnormal proteins that accumulate during the disease process,” Dr. Gliebus says. “This gives the body a signal to clear the abnormal proteins and studies have shown that it does this very effectively.

What exactly is Alzheimer’s disease?

Alzheimer’s is a degenerative brain disease and the most common form of dementia, according to the Alzheimer’s Association. Roughly 6.7 million U.S. adults ages 65 and older have Alzheimer’s and an estimated 55 million people worldwide are living with the disease and other forms of dementia.

Dr. Gliebus says that patients with early-stage Alzheimer’s may have problems with short-term memory. “Some patients have an inability to remember what they did yesterday or to remember things on a day-to-day basis. Some early-stage patients also have mild language impairment,” he says.

Possible side effects of Donanemab

Because donanemab is an infusion medication, Dr. Gliebus says there is a possibility of infusion-related reaction during the treatment or immediately after. “These can range from very mild headache or gastrointestinal discomfort to fairly severe respiratory or cardiovascular problems. That’s why infusions are always administered under medical supervision.”

Also, because the antibodies in donanemab attach to abnormal protein in the brain, the treatment can cause reactions that include slight swelling or small bleeds in the brain. “We have protocols on how to monitor the effectiveness of this medication and the possible development of side effects,” Dr. Gliebus assures.

More treatment options, more time

“This is real progress. Today’s approval allows people more options and greater opportunity to have more time,” says Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “Having multiple treatment options is the kind of advancement we’ve all been waiting for — all of us who have been touched, even blindsided, by this difficult and devastating disease.”

Dr. Gliebus says the new drug “puts us one step closer to finding a cure” and will accelerate further research. “We’re definitely moving in the right direction,” he says. “It gives patients extra months or even a year or so to maintain their function, independence and quality of life.”