New Alzheimer’s drug Kisunla has hit the market. Carol Cary is one of fewer than 1,800 people in the world who has already been taking Kisunla, receiving the drug by infusion for over a year as a clinical trial participant. Here’s her account of the experience.
In the past year, the FDA approved two landmark new Alzheimer’s drugs: monoclonal antibodies designed to attack the disease’s underlying pathology, as opposed to just treating its symptoms. Leqembi hit the U.S. market in July of 2023. Almost exactly a year later, the regulatory agency also approved Kisunla (donanemab), Eli Lilly’s Alzheimer’s drug.
Leqembi and Kisunla work slightly differently, but they both target beta-amyloid plaque, an early biomarker of Alzheimer’s that builds up in the brain as the disease progresses.
Kisunla — which, like Leqembi is approved for use in people living with Alzheimer’s in its earliest stages — has not been shown to remove amyloid plaque entirely. But it has been shown to slow cognitive decline by at least a small amount. Carol Cary, 73, is one patient who has experienced this change first hand. She was diagnosed with Alzheimer’s in January of 2023.
“I found myself being forgetful, more so than normal. That was the only symptom I had but I knew it was not normal,” Cary said.
After a visit to her primary doctor, Cary was referred to a neurologist in Richmond, Virginia, not far from her home. After a series of cognitive tests, she received her diagnosis the same day.
Shortly after her diagnosis, Cary began searching for clinical trials that she could enroll in as an early-stage Alzheimer’s patient.
“I started my research because I knew it [Cary’s Alzheimer’s diagnosis] was a bleak scenario. I found the Re:Cognition facility in Fairfax, Virginia and got in touch with them, and then I was accepted into a trial program that they were running,” Cary said. “I’ve been in their program coming up on 18 months.”
“This one [donanemab] showed promise of delaying your deterioration and to me that just looked like a shining star because the others [Alzheimer’s medications] I don’t think are effective. This drug was not available yet, and I was willing to step up and be a guinea pig if need be,” Cary said of her decision to enroll. “I don’t know of anything else I could do. I wasn’t going to sit by and let this happen. I told myself I’m gonna go out there and look for something that at least shows some promise and is within reach.”
A strict requirement to enroll is that every participant must have a study partner in the study. Cary and her husband, Richard, 78, drive two hours each way to Fairfax monthly for Cary to receive an infusion of donanemab.
“My husband is extraordinary,” Cary said. “He knows exactly what I can and can’t do. And occasionally, his patience is tested. But he’s really wonderful.”
Cary and her husband occasionally commute to Fairfax for additional appointments that are required, like MRIs and CT scans.
“I had a couple of those at the very beginning [MRIs and CT scans] and then I had a couple at the one year mark,’” she said.
She has never been told the results of the scans during the trial.
Cary noted she has been extremely happy with the level of care she receives, attentiveness from trial center nurses and physicians, and the organized manner in which per appointments are scheduled by the administrators. “Everybody bends over backwards to check on you and make sure you’re doing okay,” she said.
Beyond this, Cary said Re:Cognition reimburses her for all her travel costs — even providing lunch in the reception room and accommodations at a hotel the night before an early appointment. “We have a really nice evening when we spend the night up there,” she said. “It’s something to look forward to.”
There’s a sense of camaraderie among patients and study partners in the waiting room, and the infusion room, where participants receive their IV drip.
“When you are sitting in the waiting room or in as I call it, the ‘infusion room,’ there’s other people in there at the same time, and you can compare notes,” Cary said. “That has been something we really enjoy, because we’re all kind of in the same boat. Now we know that there are other trials going on, and we are not all getting the same med. You can tell by the hook-up in the infusion room whose is different, but it doesn’t really matter. You’re all in the same boat.”
An Alzheimer’s diagnosis often has a significant impact on an entire family. Family members often step into caregiving roles with little or no prior experience with Alzheimer’s. In the U.S., only about a quarter of dementia caregivers are from outside the circle of family and close friends. The closeness and honesty with which participants and study partners interact has grown to become one of the things Cary and her husband enjoy most about the experience.
“For my husband to be able to interact with the other study partners and for me to interact with the other patients about our experience inside and out of the study has been amazing,” Cary said. “You just don’t get that opportunity anywhere else.”
Aside from receiving regular Kisunla infusions, Cary manages her symptoms through lifestyle changes. She walks every morning with a group of women that live in her retirement community and maintains a fairly healthy diet.
Access to clinical trials is a prohibiting factor for many people, and even once it gained FDA approval Leqembi remains incredibly hard to access. In half of the U.S. counties where Alzheimer’s prevalence is the highest in the nation, there are no Leqembi infusion sites within 10 miles of the geographic county center.
Cary’s first cousin, who is also 73 and recently diagnosed with Alzheimer’s, lives on the coast of North Carolina. Despite her cousin’s interest in participating in a clinical trial, Cary says his location has prohibited him from accessing any.
“I would encourage anybody that I knew who was looking for something like this. My cousin would love to participate. There’s simply nothing he can get to,” said Cary. Some travel internationally to access Alzheimer’s clinical trials in the U.S.. Cary met a couple who flew from England monthly in order to participate in the trial in Fairfax.
While Cary is hopeful Kisunla is slowing the progression of her Alzheimer’s, she knows she can’t be entirely sure. Trial participants are prohibited from seeing the results of MRI or CT scans taken throughout the course of their enrollment.
“I’m getting a tiny bit worse as time goes on, but it’s not going downhill at a rapid pace. I’ve noticed several little changes, and I’m not standing still. I’m not staying the way I was when I started, but it’s really not deteriorating very fast,” said Cary.
Cary’s decision to enroll in the Kisunla trial was met with only encouragement from her family and closest friends.
“I think everybody is just happy that I’m doing something. My kids, friends—I think everybody considers me lucky to be a participant,” Cary said. “I can’t imagine wishing for anything else to tell you the truth. I feel lucky to be there. We’ve made a fun time out of it because we go every month.”
If you or a loved one are interested in enrolling in a clinical trial, talk to a doctor about the potential risks and benefits involved. For more information on clinical trials and to learn more about clinical trials recruiting in the U.S. subscribe to our quarterly Trials Update newsletter.
