Butler Hospital administers world’s first infusion of newly FDA-approved Alzheimer’s drug

Health

PROVIDENCE, R.I. (WPRI) — The world’s first infusion of a recently federally approved Alzheimer’s drug took place Wednesday morning at Butler Hospital, where it was first tested in a clinical trial.

Marc Archambault, 70, of South Kingstown, a research participant at the Memory and Aging Program at Butler diagnosed with early-onset Alzheimer’s disease in 2014, was the first recipient of the first Aduhelm treatment.

“I was hopeful that something like this would happen, but what’s amazing is that it’s happening for me,” Archambault told 12 News during his infusion treatment.

“If it took another few years to do this, maybe it would have been too late for me, so that’s why it’s emotional,” he added.

The drug, aducanumab, which goes by the brand name Aduhelm, was given full approval by the U.S. Food & Drug Administration last week.

The treatment is a monthly intravenous infusion intended to slow cognitive decline in people with mild memory and thinking problems.

Aduhelm is also the first new Alzheimer’s drug in 18 years.

Rhode Island played a big role in getting the Alzheimer’s drug approved, contributing one of the largest number of participants enrolled in clinical studies at both Butler and Rhode Island hospitals.

Dr. Stephen Salloway, director of neurology at Butler’s Memory and Aging Program, said participants “were involved from the beginning.” He estimated around 100 participants were enrolled in the aducanumab trial in Rhode Island since 2013.

Many of those patients remained stable on active treatment “for years,” according to Salloway.

“Today we’re making history,” he said Wednesday. “We’re opening a new era in the treatment of Alzheimer’s disease.”

“This is a turning point, and it’s just the beginning, and it can’t come too soon,” Salloway continued. “Alzheimer’s is the epidemic within the pandemic, and it’s something we have to address.”

12 News spoke to Salloway last October for an award-winning 12 on 12 Digital Original, which revealed how The War on Alzheimer’s is being waged on several fronts. In addition to Salloway, 12 News anchor Mike Montecalvo introduced viewers to people affected by Alzheimer’s in different ways.

At the time, Salloway said researchers were “on the verge of a breakthrough.” With the recent approval of the monthly infusion, Salloway believes it will bring Alzheimer’s patients and their caregivers hope.

Salloway added that the drug targets one of the core components of Alzheimer’s disease, the so-called amyloid plaques that build up early in the disease.

“It gets into the brain at low doses, it binds to the amyloid plaque, which builds up in the brain,” he explained. “It breaks it up and then it helps to clear it.”

Salloway said the main benefit is slowing down memory loss.

“Definitely with a progressive illness like Alzheimer’s, buying time early on in the disease is really important,” he said.

While aducanumab’s approval is a huge win, Salloway said he wants to build on the research.

“We want to develop blood tests that can see if you’re building up plaques in the brain. We’re very close to that. We need people to volunteer for that,” Salloway said. “So, it’s just the beginning of a whole new era.”

The treatment has been debated over the years, and Salloway acknowledges the medicine has had what he calls “a bumpy course.”

The FDA approval is controversial because previous studies have found reducing the amyloid plaque did not necessarily help patients with Alzheimer’s.

Salloway said a small initial trial of the drug was positive, but when the drug went to two larger trials in 2019, Massachusetts drugmaker Biogen halted them after disappointing results suggested the drug would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.

However, the company reversed course months later, after another look at one study showed the drug was effective in higher doses.

“My view is, the totality of the evidence and having had lots of experience with 65 people on it for years, that there’s enough benefit for it to warrant approval, and I think it really will move, accelerate the field forward,” Salloway said.

A Phase 4 trial to confirm the drug’s benefits is expected to last several years, which could result in the FDA approval being revoked. The full approval is only for those considered to have mild cognitive impairment.

The drug has also scrutinized for its cost.

“Cost is definitely an issue,” Dr. Salloway told 12 News, noting that monoclonal antibodies are biologics that tend to be expensive.

“This is our first experience with them in Alzheimer’s, but certainly for cancer, for multiple sclerosis and for others, they’re expensive and used routinely,” Salloway said.

“That is a health economic issue, that’s a personal issue for patients and families,” he continued.

Salloway said they’re waiting to hear about insurance coverage, and he’s hopeful Medicare will provide coverage.

“There certainly will be counseling programs to help people, but this is a major issue, and also making sure that it’s widely available, not just to people with good insurance or the small percentage of people who can pay for it on their own. That is a challenge with any new treatment that is a biologic like this one,” he explained.

Alzheimer’s disease affects more than 6 million Americans, including 24,000 Rhode Islanders 65 years and older, along with 38,000 caregivers.

According to the Rhode Island Chapter of the Alzheimer’s Association, the number of Rhode Islanders living with the disease is expected to increase to 27,000 by the year 2025.

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