FDA approves a new Alzheimer’s drug

• An estimated 6.5 million Americans have Alzheimer’s; the FDA has approved a new drug for people in the early stage of the disease, Cleveland Clinic specialists explain.

CLEVELAND – According to the Centers for Disease Control and Prevention (CDC), an estimated 6.5 million Americans have Alzheimer’s disease, which has no cure.

However, researchers are hopeful about a new drug recently approved by the Food and Drug Administration (FDA) for people with early-stage disease.

“When we say Alzheimer’s, it is a broad spectrum, ranging from very early stages to very advanced dementia,” said Dr. Babak Tousi, a geriatric neurologist at Cleveland Clinic.

“At the moment, there are no findings to support using this drug for people with moderate to advanced dementia. It is for people in the very early stages of the disease.”

The drug, called Lecanemab, is designed to reduce beta-amyloid plaque in the brain. Beta-amyloid plaque has been linked to Alzheimer’s disease.

Dr. Tousi explained that the drug does not treat the symptoms of the disease but helps slow its progression.

As for success rates, results from an 18-month clinical trial showed that participants who received the drug had a 27 per cent reduction in beta-amyloid plaque. Dr. Tousi said that percentage may seem small, but he believes it is a good starting point.

“It looks like we have some treatment. We can affect the trajectory of the disease. It’s a small benefit, but it’s still a benefit,” he said. “We can slow it down, and I think it’s one of many to come in the future to target it, so that’s the biggest breakthrough for us.”

Documented side effects of the drug included microbleeds and oedema, which is a build-up of fluid in brain tissue.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical centre that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based on the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States.  

U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 72,500 employees worldwide are more than 5,050 salaried physicians and researchers, and 17,800 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties.  Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 21 hospitals, more than 220 outpatient facilities, and locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England.

In 2021, there were 10.2 million outpatient visits, 304,000 hospital admissions and observations, and 259,000 surgeries across Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries.  

Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

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