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A new drug approved this month by the U.S. Food and Drug Administration intended to slow cognitive decline in Alzheimer’s patients has garnered mixed reactions from local Alzheimer’s researchers.
The drug, which will go by the brand name Aduhelm, was approved via the FDA’s Emergency Use Authorization track on June 7 — the first Alzheimer’s medication to be approved by the agency since 2003. Biogen, the drug’s maker, has said it will charge $56,000 a year per patient.
“I know if this was one of my close family members, I wouldn’t advise taking it — not just because of cost, but mainly because of the risk-benefit ratio,” said George Perry, a University of Texas at San Antonio neurobiology professor who studies Alzheimer’s disease.
Biogen claims Aduhelm works by decreasing the amount of amyloid plaque in the brain of an Alzheimer’s patient, which in turn may slow the patient’s cognitive decline.
But it’s still not proven that amyloid plaque in the brain is causing Alzheimer’s symptoms, Perry said. Amyloid plaque is a protein in the brain normally processed by the body. In Alzheimer’s patients, buildup of the plaque can stop brain cells from working properly. While it is certainly correlated with Alzheimer’s, getting rid of amyloid plaque does not guarantee increased cognitive function, said Perry.
With no new drug in almost 20 years to show for millions of dollars in research, the FDA likely felt pressured to approve something, he said, adding that he’ll be watching see the results as the drug enters the market for more people.
“There’s no cure from any of this,” Perry said. “There is a chance of a change in decline … I think every family has to decide for [it]self whether that has value right now.”
Several other potentially game-changing Alzheimer’s therapies are currently being studied and tested in San Antonio.
Dr. Sudha Seshadri, the director of the Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases, is divided on how to feel about the new drug. While she thinks its approval on the Emergency Use Authorization track is significant since it means the FDA recognizes Alzheimer’s as a major deadly disease, she feels more research on Aduhelm is needed.
The drug has been shown to have some potential major side effects, such as brain swelling, dizziness, and in some extreme cases brain hemorrhaging, which makes Sheshadri wonder if the benefit worth the risk. She isn’t sure it is.
“We do recommend that [researchers] continue to monitor what happens when you give it to people,” she said. “If at some point after approval, it’s found that it does work, then they can give it a full approval. Through this [Emergency Use Authorization] track, they still have the ability to take back the approval.”
As part of its emergency approval, the FDA ordered Biogen to study whether the drug actually slows cognitive decline. If it doesn’t, the FDA could withdraw its approval.
Sheshadri said she hopes a sufficient number of Hispanic patients will be part of the follow-up studies. As of 2019, Alzheimer’s was the fifth leading cause of death in San Antonio and the sixth leading cause of death in Texas.
Because Hispanics are 50% more likely to develop Alzheimer’s than non-Latino whites, Alzheimer’s poses a unique threat to San Antonio, which according to the latest U.S. Census Bureau data is almost 65% Hispanic.
“We know that … Hispanic populations are more likely to get Alzheimer’s and be diagnosed later,” said Lisa Ayres, vice president of development for the San Antonio and South Texas Chapter of the Alzheimer’s Association. “Alzheimer’s is devastating in San Antonio, so any progress is good progress.”
The Alzheimer’s Association “welcomes and celebrates the FDA approval” of Aduhelm, Ayres said. Ayres added the association hopes this first Emergency Use Authorization drug approval for Alzheimer’s by the FDA will quickly lead to the approval of other related drugs as well, including those being tested in San Antonio.
“We hope that this will encourage the scientific community to continue their research and continue to develop treatments for Alzheimer’s, as well as for other dementias,” she said.
To support these efforts locally, the Alzheimer’s Association chapter financially supports research at several San Antonio institutions through grants, including at the Biggs Institute, Trinity University, and the University of Texas at San Antonio.
The Biggs Institute has eight clinical trials underway studying Alzheimer’s, Parkinson’s disease, and dementia treatments, Seshadri said.
“Broadly, [our] goal is to understand the biology of not just Alzheimer’s but what is called ‘related dementia,'” she said. “[We want] to particularly focus on understanding it in Hispanics.”
The institute is studying some promising Alzheimer’s treatments originally developed to treat something else, Seshadri said.
One, rapamycin, has shown beneficial effects on rats in animal studies, Sheshadri said. Now in clinical trials at the Biggs Institute, the drug approved to prevent organ transplant rejection is being tested to see if it also slows the rate of decline for patients with Alzheimer’s.
Another trial will test 3TC, an FDA-approved drug used commonly for HIV and hepatitis B patients. Research shows that 3TC could slow Alzheimer’s progression in patients diagnosed early by targeting certain viral components.
The institute also is studying lecanemab, another amyloid-targeting drug that could slow the rate of decline for patients.
The institute will get the chance to “carefully monitor the response” of patients in the area who are taking Aduhelm, Sheshadri said. She encouraged anyone locally taking the drug, especially those of Hispanic descent, to participate in the post-phase study.
“We will follow up to see how effective the drug is seen to be in the real world, what is the incidence of side effects in the real world,” she said.
