Despite Controversial Approval, Arrival of New Alzheimer’s Disease Drug Brings “Hope” to Louisiana | Healthcare / Hospitals

After the controversial approval earlier this month of the Alzheimer’s drug aducanumab, interest and hope for this expensive treatment is high in Louisiana, a state heavily affected by Alzheimer’s disease. Alzheimer’s.

The United States Food and Drug Administration approved the infusion therapy targeting a protein associated with Alzheimer’s disease on June 7. But the approval came despite an independent committee’s decision not to approve it. After FDA approval, three of the 11 voting members of the FDA panel committee resigned, citing disrespect for the committee’s recommendation and concern over how similar drugs in development will be treated. in the future.

This has left doctors and other caregivers in Louisiana, where about 92,000 residents over the age of 65 have Alzheimer’s disease, trying to weigh for themselves whether the benefits are worth the risk – and the cost. About 204,000 people care for these patients, most of them unpaid family members, according to a 2021 report from the Alzheimer’s Association.

Dr Demetrius Maraganore, chair of the neurology department at Tulane University School of Medicine, said that since the approval “the phone has been ringing hard” with people who have questions about the drug. and if he could help their loved one.

“Until June 7, we really didn’t have any tools in our Alzheimer’s toolkit,” said Maraganore. “We had bandages, medicines that sometimes improved the symptoms a bit. For the first time, we have a toolbox and now it’s open.

But there’s plenty of criticism of the drug, which Biogen, its manufacturing company, expects to ring at $ 56,000 per patient per year before insurance. While supporters say the approval may encourage other drug companies, many of which have abandoned Alzheimer’s research in recent years, to stay in the fight, critics say the risk – and the cost – outweigh the benefits.

The FDA is asking the drug maker to conduct a follow-up study to confirm the benefits for patients.

“The scientific community is concerned, and I am one of them,” said Dr Nicolas Bazan, director of the Center of Excellence in Neuroscience at LSU Health and assistant professor at the Karolinska Institute, a Swedish university of medicine and of research. “It’s very strange for me as a scientist to witness the approval of this. There really are unprecedented irregularities.

Stanley Cohn is one of thousands of caregivers who are trying to figure out whether to continue with the new treatment. His wife was diagnosed three years ago at the age of 62. She was prescribed the usual medications now available for Alzheimer’s disease, which only treat the symptoms rather than the underlying cause of the disease. Cohn can’t be sure they are making a difference.

“When you’re desperate, you hope,” said Cohn, 65, who lives in New Orleans. “This drug gives a little hope. But as of the time of reading, not as hopeful as I thought.

Aducanumab, which will be marketed under the brand name Aduhelm, is intended to slow cognitive decline caused by Alzheimer’s disease, the most common type of dementia. It does this by targeting amyloid, a protein that accumulates and clumps together in plaques in the brains of Alzheimer’s patients that many scientists say causes the disease. It does not reverse the disease and does not cure it.

The drug is administered by a monthly intravenous infusion.

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Both aducanumab clinical trials were only conducted with people in the early stages of the disease whose brains had high levels of amyloid.

In both studies, patients had decreased amyloid levels. In one of the two trials, the drug was also shown to slow cognitive decline. People who received the drug fell 22% slower than those who received the placebo.

But the other trial showed no benefit for the patients. And the FDA’s label for the drug does not take into account the severity of the disease – it simply says “for the treatment of Alzheimer’s disease.”

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That leaves the prescription to the doctor. Some doctors in the area have said they are still trying to figure out what their prescribing requirements might be, keeping in mind that the drug has only been tested on people with a certain degree of independence.

“I think we are looking at the test criteria that have been studied,” said Robert John Sawyer, neuropsychologist at Ochsner Health. Louisiana’s largest health care system is trying to come up with guidelines for who would benefit from the drug. Other factors will involve the discretion of the prescribing physician and emerging evidence as more studies provide additional data.

Maraganore said he would require patients to undergo an MRI within 1 month of starting treatment and a cerebrospinal fluid exam to make sure they actually have more than normal amyloid in the body. brain. Although amyloid plaques are considered a hallmark of Alzheimer’s disease, they do not occur in other types of dementia, such as vascular dementia and frontotemporal dementia. For these patients, the drug could be dangerous.

But there are also risks for people who meet the criteria for the trial. About 40% of patients in both studies experienced swelling or bleeding in the brain after taking aducanumab, although it was described as mostly mild.

“What you need to do is see the risk-benefit ratio,” said Bazan, who works in research full-time and doesn’t see patients in the clinic. “The risk here is huge and the payoff is minimal at best. “

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Bazan falls into a camp of neurologists who believe that an anti-amyloid drug is not enough to stop Alzheimer’s disease. He and others often bring up a spaghetti-like protein called tau and neuroinflammation, also found at high levels in the brains of people with Alzheimer’s disease. He is studying how stopping inflammation very early in the progression of the disease could stop Alzheimer’s attack on the brain.

Due to the uncertainty of the drug’s effectiveness, the FDA also asked Biogen to conduct a Phase 4 trial with real-world participants over nine years. The study will recruit 6,000 people at 200 sites, said Maraganore, including at least one he will lead in the New Orleans area. Biogen did not respond to requests for a list of study sites.

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Aduhelm could be on the shelves in just two weeks, according to Maraganore, who is in contact with Biogen, the drug’s maker. But it will take time to start the official Phase 4 trials – probably two or three months, he estimated.

In the meantime, Maraganore, who sees patients at clinics in Covington and Metairie, will enroll patients in another trial, the International Collaboration for Real-World Evidence in Alzheimer’s Disease, or ICARE-AD, another Phase 4 study. which will provide data for the continued FDA approval of the drug.

“We need more information,” said Maraganore. “I am still in the process of learning more about this treatment and I am still deciding if this treatment is effective and safe, and I want to do it in a carefully monitored clinical trial.”

Ochsner will potentially be involved in the FDA-mandated Phase 4 site and recruit racial and ethnic minorities for the ICARE-AD study, Sawyer said.

Cohn is still in the process of putting together his own research to decide if this is something he will pursue for his wife.

“I ask caregivers who I know see doctors at some of these top institutions, ‘What do you mean from the Mayo Clinic? Well, here’s what I hear from Northwestern, ”said Cohn, who estimated that he and his wife visited 15 of the top clinics in the United States during his illness.

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