FDA grants approval to Alzheimer's drug that slows progress of disease

Although it cannot reverse the damage caused by the plaques that are the hallmark of Alzheimer’s disease, a promising new drug may slow its progression, studies show.

Earlier this year, the Food and Drug Administration gave its stamp of approval to Leqembi — a medication that reduces the beta amyloid plaque load in the brain. 

“The data was pretty convincing that this drug was doing something for Alzheimer’s,” said ClinCloud Medical Director and Principal Investigator Dr. Esteban Olivera. “We are not saying that Lecanemab (Leqembi) is the ideal drug for Alzheimer’s, but it’s the only drug that we know that has gone through the FDA process.”

Olivera oversees two studies that explore the drug’s impact when introduced during the disease’s earliest stages. 

“It looks like the success of this drug will depend on how early we can start (the patients),” he says.  

By the time Alzheimer’s symptoms present, the beta amyloid plaques have been accumulating for years, meaning the load is already immense. And once the brain cells die, there is no way to reverse the damage.  

That said, for those who began intervention early, there is hope. 

“In the patients that I have, I didn’t see a significant deterioration during the study,” Oliveras said. “I saw them keeping especially the activities of daily living… That decline in ability to do activities of daily living was reduced by 37%.” 

His double-blind study began in 2019, and participants were recently offered an open label extension. 

As for side effects, Oliveras observed minor dizziness and nausea. 

“It seems like patients go through a process of adaptability and symptoms start to go away and they are able to tolerate the drug well,” he said. 

Sometimes, an increase in blood pressure followed an infusion.

Other side effects included micro hemorrhages and brain swelling edema.

Overall, though, excitement surrounds the medication and the FDA’s recent nod of approval. 

Officials with the National Institute on Aging said of the agency’s blessing: “This occasion — combined with ongoing scientific pursuits and advances in Alzheimer’s and related dementia research — helps mark decades of scientific progress toward effectively treating and preventing these diseases. NIA remains eternally grateful to the research community as well as to the many clinical trial participants who have played significant roles in advancing knowledge, data, and discoveries.”