The FDA has approved a game-changing drug for Alzheimer's disease. What should you know?

In this article: 

  • A Swedish brain health expert shares information about Leqembi, a groundbreaking new drug for the treatment of Alzheimer's disease. 

  • While it is not a cure, the new drug has shown promise in arresting the cognitive decline associated with early-stage Alzheimer's. 

  • Lifestyle changes can help prevent dementia and slow the progression of Alzheimer's disease. 

Alzheimer’s disease affects some 6.5 million Americans. The progressive, irreversible disease robs those affected of cognitive abilities and memory, eventually rendering them unable to carry out simple tasks and activities of daily living. A newly approved drug is giving millions of Americans hope and showing promise in its ability to slow the cognitive decline associated with Alzheimer’s disease.  

On July 6, The U.S. Food and Drug Administration (FDA) fully approved a groundbreaking drug used to treat Alzheimer’s disease. It is the first drug of its kind and has shown a proven ability to modestly slow the cognitive decline associated with Alzheimer’s disease.

The drug, known as lecanemab under its generic name and sold under the brand name Leqembi, received conditional approval from the FDA in January, after showing significant promise in an ability to slow memory decline. Following more trials confirming the results, the FDA announced that it had fully approved the drug. In studies reviewed by the FDA, Leqembi appeared to slow memory and cognitive decline by some 27% over 18 months of treatment.

“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”

To learn more about the drug and how it works, we spoke with Nancy Isenberg, M.D., medical director of the Swedish Center for Healthy Aging, who shared five important things to know about this new drug.  

How does Leqembi work?

Lecanemab is a monoclonal antibody (a protein that helps your immune system target specific proteins for removal) designed to remove amyloid beta, a protein involved in Alzheimer’s disease, from the brain.

Who are the best candidates for this drug?

People with early-stage Alzheimer’s disease and people with mild cognitive impairment due to Alzheimer’s disease. People need to have a firmly established diagnosis of Alzheimer’s disease with evidence of brain accumulation of amyloid with either a lumbar puncture or a specialized brain scan. The drug is not helpful for patients with moderate to advanced Alzheimer’s disease.

What are the risks associated with Leqembi?

The drug can cause bleeding and swelling in the brain that is often mild to moderate and may resolve on its own, which in some cases is serious enough that the FDA required a “black box warning” for the drug given its risk of “serious and life-threatening events.”

People who are on blood thinners or who have microscopic brain bleeds on MRI or who have an Alzheimer’s linked gene mutation called ApoE4 have a greater risk of brain bleeds and swelling.

Is this new drug expensive?

The annual cost of the drug is $26,500, and Medicare will pay for 80% leaving patients with substantial co-payments of over $6000/year. Additional costs include medical visits for the drug infusions, regular brain scans to monitor for swelling or bleeding in the brain. Estimated total cost for Leqembi is about $90,000 a year, leaving patients with significant out of pocket costs estimated at $18,000 per year.

Are there alternative treatments?

There is no cure for Alzheimer’s disease. There are other medications which can help with symptoms. Care partner education and support along with dementia friendly community programs and services are critical components of dementia care. In addition, there are lifestyle medicine approaches which can help prevent dementia and slow disease progression.

Learn more and find a provider

If you have a confirmed diagnosis of either dementia or Alzheimer’s disease, ask your provider to refer you to Swedish’s Center for Healthy Aging, which is located at our Cherry Hill Campus. For more information about services and programs, call 206-320-7200.

With Swedish Virtual Care, you can connect face-to-face with a nurse practitioner who can review your family and health history. To find a provider, try searching our provider directory.

Join our Patient and Family Advisory Council.

Related resources

Tips for Healthy Aging: A Conversation About Dementia with Dr. Nancy Isenberg

Want to stay in your home as you age? Planning and healthy habits can help.

First Hill block party raises brain health awareness

Swedish hosts inaugural Healthy Aging Summit

This information is not intended as a substitute for professional medical care. Always follow your health care professional’s instructions.

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About the Author

From deep brain stimulation to focused ultrasound to pediatric neurology, The Swedish Neuroscience Team is recognized as national experts to help people address a wide array of neurological conditions. Our goal is to provide useful and helpful advice and tips on non-surgical and surgical options to treat any disease of the mind.

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