For Georgians living with early stage Alzheimer’s, hope has turned once again to a new drug being touted as a game-changer.
Eli Lilly and Co. recently announced it planned to seek regulatory approval from the U.S. Food and Drug Administration for donanemab, which it says appears to slow the progression of the degenerative disease for people in the early stages.
In 18-month trials, patients who received infusions of donanemab showed 35% less decline in cognitive skills compared to those given a placebo, according to a press release from Lilly.
It’s not the only drug raising hope.
Earlier this year, the FDA appoved lecanemab, a drug co-developed by Biogen and Eisai, a Japanese pharmaceutical company.
According to the Alzheimer’s Association, there are more than 150,000 Georgians 65 and older living with the disease, compared to 6.7 million nationally. Alzheimer’s is the most common of the dementias, diseases that affect memory, thinking and behavior.
Severe, late-stage Alzheimer’s is ultimately fatal. In Georgia, the disease caused 4,221 deaths in 2019, the latest available data.
It can take years for new drugs to make their way through the pipeline.
Meanwhile, people with Alzheimer’s and their families are desperate for the magic bullet that at least slows progression of the disease.
Each time she hears of a new drug, Arthena Caston of Macon says, “Lord, please let this be the one.”
Caston, a grandmother, was diagnosed with Alzheimer’s in March 2016 when she was 51.
Her physician said the disease is progressing slowly and she is still considered early stage. She may forget names and doesn’t venture to places she’s never been to on her own.
She got excited about the controversial drug, aducanumab, marketed as Aduhelm, which was fast-tracked by the FDA, but her former doctor didn’t approve it.
“Now, I’m just hoping,” she said.
While there is hope for these drugs, some remain cautiously optimistic or voice concerns of the need for more research.
These drugs and others recently approved or in the pipeline generally target people with mild cases of the disease. It’s hard to gauge how many people are in the early stage of Alzheimer’s, compared to those with moderate or advanced cases, said Leslie Tripp Holland, a spokeswoman for the Georgia chapter of the Alzheimer’s Association.
It is estimated that every day, about 2,000 people nationwide progress to the point that they would not be candidates for the new drugs any longer, says Holland, whose father had Alzheimer’s.
Dr. Jonathan Liss, a neurologist at the Columbus Memory Center also a member of the board of the Georgia chapter of the Alzheimer’s Association, has run multiple trials, including those for lecenemab and donanemab.
“For younger sufferers of this disease, these new drugs are likely to be part of an eventual collection of medications designed to slow down progression,” he said. “There are numerous promising FDA-approved research trials attempting to slow or cure this disease, from many different vantage points.”
Since most of the people diagnosed with Alzheimer’s disease are elderly, these two new drugs are “potential game-changers,” Liss said.
Experts say these medications may slow disease progression enough to allow people to maintain independence, stay in their home longer and have an opportunity to participate in decisions about their care and finances.
Liss said about 12% of older Americans get an annual cognitive test.
“This is part of the reason why 50% of all sufferers lack a diagnosis, and it will be a major part of the reason why most people will be diagnosed at a stage too late to take advantage of these new medications. “
In 2021, several scientists and FDA advisers resigned over the agency’s approval of Biogen’s controversial and costly drug, Aduhelm, saying there was not enough strong evidence that it helped people suffering from the disease.
And while there is hope for donanemab and other potential drugs, some also want to see additional research.
Among them is Lisa Renzi-Hammond, director of the Institute of Gerontology at the University of Georgia.
While it’s important, she said, to be able to utilize these faster-approval pathways for people who are suffering from the disease now. “It’s also important to continue research on the drugs to protect future patients and allow them to make more informed decisions.”
She’s concerned about side effects, such as brain bleeding and swelling, some of which may not show up until later, as well as cost and accessibility for follow-ups for rural patients.
“Cost is going to be an issue, no matter what,” she said.
Alzheimer’s by the numbers:
Projected increase of people aged 65 and over living with the disease by 2025:
Nationwide: 7.2 million (a 7% increase from 2023)
Georgia: 190,000 (a 26.7% increase from 2023)
- In Georgia: between 2000 and 2019 there was a 241.8% increase in Alzheimer’s deaths.
- Age is the greatest risk factor for Alzheimer’s and other dementias.
- Black Americans are twice as likely than white Americans to develop Alzheimer’s as they age.
- *Hispanic Americans are 1.5 times as likely than whites to develop Alzheimer’s as they age.
Source: Alzheimer’s Association