When the news came out last month that an experimental Alzheimer’s therapy succeeded in a clinical trial, it provided a rare boost of hope for the millions facing the condition. A select group of patients felt something more: lucky.
In interviews, people who participated in the trial and their caregivers described a gratitude at somehow winding up in a study where the drug actually worked, against a backdrop of repeated failures to develop effective Alzheimer’s medications. They in effect got early access to a treatment that will only become available to others months from now, should regulators approve the medication.
“Being able to be in the front of the line for what may be a major change for everyone who has my problem,” was how one participant, 80-year-old John “Jack” Driscoll, described it.
“Cautiously optimistic, and cautiously ecstatic,” was how Paul, whose wife Linda was in the trial, said he felt when he heard the news. There was caution because he had read about past purported successes in Alzheimer’s going bust, but excitement because if the results held up, it would mean more time with Linda. (Paul and Linda, who live in the St. Louis area, asked that their last name be withheld to protect their privacy.)
The announcement from companies Eisai and Biogen that the therapy, lecanemab, slowed the progression of Alzheimer’s over 18 months versus placebo was also a long time coming for trial participants, some of whom started the eligibility and enrollment process more than two years ago.
But they still faced some questions, namely — had they been receiving lecanemab or placebo? Patients have not yet been informed which arm they were in, they said.
The study, called CLARITY-AD, remains blinded for participants and investigators, an Eisai spokesperson confirmed. However, after patients completed the study phase, they were able to move into an extension of the study in which everyone has been receiving lecanemab.
The participants who spoke with STAT were also clear-eyed about what it meant when the clinical trial indicated lecanemab “works.” The medication is by no means a cure for Alzheimer’s, and can’t reverse cognitive losses. Rather, lecanemab put a drag on the progression of the disease, the companies said. Experts are debating whether such a statistical difference — a 27% reduction in the rate of cognitive decline — will translate into any meaningful or noticeable real-world change, a crucial point given that therapies like lecanemab come with the risk of side effects including brain swelling and bleeding.
But patients and their families said that even if lecanemab can’t stave off further decline, if it can delay it for even just a little bit, that would provide real benefits — more time to be themselves, and to spend time as themselves with loved ones, and to be independent. Several participants described how dealing with an Alzheimer’s diagnosis and the accompanying cognitive issues was not how they and their spouses anticipated spending their long-awaited retirements.
“You feel like you’ve been robbed,” said Jerry Fair, 66, who was diagnosed with Alzheimer’s just before his 63rd birthday. Fair’s wife of 45 years, Deb, described going through something resembling a mourning process when they found out Jerry had Alzheimer’s. The Fairs, who live in Dover, Ohio, have three children, five grandchildren, two cats, and a dog.
“You always think you’re going to have some time at the end of your working days when you can do things together that you want to do,” Deb said. “And then you see that that may not happen.”
Deb still works part time, and Jerry, who spent his career working at a food processing plant, likes that he is independent enough that he can help out around the house by taking care of the laundry, for instance. Jerry, who enrolled in the trial through the Cleveland Clinic, knew he might very well end up on placebo, but he still saw the value in helping other patients by participating in a research study.
“I feel bad for my wife Deb to have to witness the slow decline and demise of someone she loves, and that’s hard to take,” Fair said. “For me, that’s harder to take than what I actually have. I know that even with today’s medicines and stuff, it’s helping, but there is going to be decline and things like that. I’m not being stoic or anything, but that’s acceptable because this is the early stages of a new drug. Like I said, I did it first and foremost for Deb, and secondly, if I could be a part of something bigger than myself to help someone else, I want to do it.”
Driscoll, who retired as an aviation consultant after a career working for the city of Los Angeles and LA’s airport agency, said it was around the time he enrolled in the trial at UCLA that he saw he was, as he put it, “faltering a little bit more.”
“Names would be lost,” he said. “I’d look at my phone and of course I’ve got a gazillion names on there and I would very often forget who those people were.”
With lecanemab, Driscoll said, he’s hoping that he’ll have more time when he can read and write, and to be with his wife, children, and grandchildren.
Paul, whose wife Linda participated in the trial at Washington University School of Medicine, likened his role helping Linda to how someone with poor vision needs eyeglasses. Linda still does lots of daily activities and chores independently, but sometimes she leans on Paul. When, over the phone, Linda couldn’t remember when she was initially diagnosed with mild cognitive impairment, Paul provided the answer. “That was an eyeglass moment,” he said.
Linda, 71, said she obviously hopes lecanemab can give her more time with her family when she still is aware of what is going on. But she also said that she tries to avoid the anger she sees some people in her Alzheimer’s support group have at their diagnoses. She understands that feeling, of course, but she’s also tried to live her life as it comes, as she’s done since well before she started having memory troubles, and in whatever shape that takes.
There’s another group of patients wondering what the results from the Clarity trial might already mean for them. Another study, called Ahead, is testing lecanemab in people who are not exhibiting any signs of Alzheimer’s, yet have the telltale plaques of amyloid protein building up in their brains. If lecanemab is truly effective, it’s going to have the biggest benefits when used as early as possible, experts believe.
Curt Casteel, 69, is one of the participants in the Ahead trial. To know you’re considered at risk for developing Alzheimer’s but to not have any symptoms is a strange thing, he said.
“It does make you pause and it makes you a bit paranoid,” said Casteel, a retired U.S. marshal who lives with his wife Kathy in Columbia, Mo. “You start watching. If I grope for a word now, it’s like, is this the beginning, or is this normal?”
Casteel, who doesn’t know whether he’s receiving lecanemab or placebo in his study, knows that there’s not going to be a cure for Alzheimer’s any time soon. But looking at lecanemab’s performance in the Clarity trial, he can’t help but want for something more. “It’s a good thing, you just wish it was better,” he said of the results.
He also wonders, if he is receiving lecanemab, whether it’s prolonging how much time he has before he potentially starts experiencing symptoms.
“If it means a few more weeks, a few more months, at the human level, that’s going to be significant,” he said.
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