New Alzheimer's drug in demand, but who should take it?

A new drug for treating Alzheimer's disease gives new hope to those affected and their families.

Donanemab, developed by Eli Lilly and sold under the brand name Kinsula, was approved by the Food and Drug Administration in July to treat patients with early-stage Alzheimer's disease and people with mild cognitive impairment.

In the weeks that followed, USF Health's Memory Disorders Clinic and the Byrd Alzheimer's Center and Research Institute received more than 50 calls from patients and families hoping to obtain a prescription for the drug.

But the drug is not right for every Alzheimer's or dementia patient. Its potential side effects and risks, compared to the limited benefits for people with advanced Alzheimer's disease, mean specialists have to say no to many patients, says Ram Bishnoi, an associate professor at the University of South Florida who practices in the department of psychiatry and health behavior at the Byrd Alzheimer's Institute.

“There are so many phone calls,” he said. “We are already overwhelmed with patients.”

Here is a summary of what Alzheimer's patients need to know about the new drug:

Why is the demand for donanemab so high?

An estimated 6.7 million Americans live with Alzheimer's, which was the fifth leading cause of death among people age 65 and older in 2021, according to the Alzheimer's Association. In Florida, about 580,000 people have been diagnosed with the disease, which costs the state's Medicaid program $3.4 billion a year.

Alzheimer's is caused by the buildup of amyloid proteins that form plaques in the brain. The disease affects functions such as memory and muscle coordination. Although donanemab is not a cure, clinical trials have shown it can significantly slow the progression of the disease. It cannot reverse memory loss or loss of cognitive function.

Who should take the medicine?

According to the FDA, the drug is approved for People with early-stage Alzheimer's disease, which includes mild cognitive impairment, and people with mild dementia who have been shown to have a buildup of amyloid plaques. The drug is not effective in people with moderate or severe Alzheimer's disease. It is also not suitable for people with dementia for other reasons.

How does the medicine work?

Donanemab is a monoclonal anti-amyloid antibody that is given intravenously once a month. The antibodies in the drug bind to amyloid proteins and remove them.

What are the risks?

Side effects of the drug include amyloid-related imaging abnormalities, which typically show up as swelling and small bleeding in the brain. In most cases, these side effects are only detected by magnetic resonance imaging (MRI) and patients are unaware of them. There is also a risk of infusion-related reactions such as flu-like symptoms, including Nausea, vomiting and changes in blood pressure.

Are there other factors that increase the risk?

Yes. People taking blood thinners or anticoagulants are at high risk of side effects that can be fatal. Doctors should exercise “extreme caution” when prescribing the drug in these cases, Bishnoi said.

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People who cannot undergo an MRI, such as those with metal implants, should also not be prescribed the drug because MRIs are used to monitor adverse reactions in the brain, Bishnoi said.