Local Alzheimer’s patient, doctor react to FDA approval for new drug therapy

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ALBANY, N.Y. (NEWS10) — Gino Bureau’s life hasn’t simply been touched by Alzheimer’s, nearly his whole family has been ravaged.

“I am the youngest of six siblings and it has been tough,” Bureau explains. “Two of my siblings have already died from the disease. They actually died within one month of each other last year and then I have one sister that’s in assisted-living. The other two haven’t yet shown any symptoms, but they are of course scared based on our genetic history.”

That’s why when he started to see the signs in himself, it was all the more terrifying.

“Dates and times are really tough. If I didn’t have a phone, what a helpful tool that is for me,” Bureau says in an interview with NEWS10’s Mikhaela Singleton. “And to clearly, to clearly say what I want to say. Sometimes I’m using the wrong words, and that’s kind of difficult.”

Now, hope is finally on the horizon. The FDA’s contingency approval for the new, early-stage Alzheimer’s treatment, aducanumab, is not only the first approved therapy in almost 20 years — it’s also the only one of its kind designed to slow disease progression.

“Medicines that we’ve had to this point are really symptomatic medicines. They can help to compensate for memory deficit, but they don’t really affect the underlying disease process,” explains Dr. David Hart, who is both a professor of neurology and a practitioner at The Alzheimer’s Center of Albany Medical Center. “Aducanumab helps to slow the changes in the brain, helps to reverse the amyloid accumulation, and really is attacking the disease process itself.”

Amyloid is a protein that can cause plaques when too much is built in the brain and is considered one of the early warning signs of Alzheimer’s, Dr. Hart explains. He says the clinical trials for aducanumab showed promising signs at breaking up some of these proteins; however, controversy remains since one of the two trial groups showed no benefit.

“Maybe the reason that the second trial was not effective is not as many patients were at the high dose for long enough. That is one interpretation of the data. We don’t know that for sure, but we do know the data showed statistical benefit,” Dr. Hart says.

“Keeping in mind, the changes that happen to the brain during Alzheimer’s are happening for several decades before they start showing symptoms, so by the time patients start to exhibit memory loss, finding something that is going to come in at a relatively late date and try to affect this process that has been building and building for years is a tough ask,” he concludes.

While the experts weigh the pros and cons, eligible patients and their families are already desperate to get their hands on aducanumab. Dr. Hart says in the 24 hours since the FDA announcement, several of his patients have either called, sent messages, or brought up the news in their appointments, all asking when they can try the new infusion therapy.

He says, unfortunately, even though aducanumab is approved for those with mild impairment and in the early stages of Alzheimer’s, it won’t hit the market for some time. Health insurers and Medicare haven’t yet set the threshold doctors will have to meet before prescribing aducanumab.

“They may require a patient first get an MRI or provide some other basis of proving that what they’re experiencing is indeed Alzheimer’s and not some other medical event,” Dr. Hart explains.

Still, industry leaders are hopeful this will inspire more interest in Alzheimer’s research.

“This is not the be-all and the end-all in the fight against Alzheimer’s disease,” says Beth Smith-Boivin, the executive director of the Alzheimer’s Association, Northeastern New York. “We hope that it will be the springboard to invigorate researchers, invigorate funding, and just as importantly, invigorate people to participate in clinical trials. We have very low trial participation rates among Alzheimer’s and dementia patients.”

Aducanumab’s progress through the FDA Accelerated Approval Program means drug companies will have to conduct further studies and whether or not to keep it on the market will be determined after Phase 4 confirmatory trials.

Gino Bureau has mild impairment and qualifies to take part in the next round of trials. He says a real cure may not come close to his horizon, but he has hope for his family and their fear of genetic progression.

“I have a granddaughter that’s three years old, and I pray that there will be a cure for her and for my children, if they need it,” he says.

“Families have been waiting so long to see something move the needle in the direction of true hopefulness, and this is it,” says Smith-Boivin.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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