Bill Sasse was a participant in Eli Lilly’s clinical trial of the experimental monoclonal antibody drug solanezumab, which was ultimately discontinued. He joins Being Patient Live Talks to discuss his experience with the clinical trial.
The process of finding new treatments for Alzheimer’s disease is one of trial and error — and every “failed” trial generates invaluable new data to help researchers and drug developers understand what works, what doesn’t, and why. One such trial was solanezumab, which in March of 2023 ultimately failed to hit its benchmarks in slowing cognitive decline, and the trial was discontinued. However, with multiple participants and years of research, there are still some insights to be gained on the clinical trial process and how monoclonal antibody drugs, or MAB drugs, are developed.
Bill Sasse, whose father died of Alzheimer’s, had the unique experience of participating in this clinical trial without having any symptoms of cognitive decline. An army veteran, retired business owner, grandparent, and a native of Columbus, Indiana, he joined the trial after being inspired by a documentary about Glen Campbell promoting the trial, asking himself, “Why not, me?”
With his wife as his trial partner, he participated in the solanezumab trial for eight years before it was announced that the clinical trial had failed. He has participated in panels with Eli Lilly on his experience with the trial.
Sasse joins Being Patient Founder Deborah Kan to discuss his experience with the trial and advice for people interested in participating in Alzheimer’s research. Read or watch the full conversation below.
Being Patient: How did you find out about the trial, and which one were you in?
Bill Sasse: I found out about the trial through watching the TV special that Eli Lilly sponsored in 2015. It was all about the journey of Glen Campbell. He had been diagnosed with Alzheimer’s, and they had agreed to do one final tour. He and his family agreed to let the progress of the disease be documented throughout this tour.
It was originally planned for only 15 dates, but then it was so popular, they played for about 120. At the end, there was a solicitation for a drug trial of Eli Lilly’s new Alzheimer’s experimental drug, solanezumab.
I had some history in my family of dementia and Alzheimer’s, my extended family, and more closely with my father and my grandmother. I had never really thought about being in a drug trial, but after watching this, I thought maybe I should pursue it. I couldn’t come up with any good reasons not to, so I did.
“I had never really thought about being in a drug trial, but after watching this, I thought maybe I should pursue it. I couldn’t come up with any good reasons not to, so I did. “
Being Patient: Had you been diagnosed, or were you experiencing cognitive difficulties?
Sasse: I hadn’t. I wasn’t aware of any cognitive problems, and I didn’t know anything about my personal situation. I just knew that I had some in the family. I guess that thought was always kind of lingering back there that I may be faced with that someday myself.
Being Patient: How many family members had been diagnosed at that point with Alzheimer’s?
Sasse: Well, I don’t know. My grandmother was one of 10 children, and I know several of those siblings suffered from dementia. Whether it was called Alzheimer’s back then, I don’t know. [With] my grandmother, they called that “hardening of the arteries.” My father was diagnosed in 1992, and his symptoms were no different than my grandmother’s and several of those others.
Those were all 40 or 50 years ago, with the siblings, and so I think if they were around today, they probably call it Alzheimer’s, but at any rate, I knew that my father was diagnosed. Alzheimer’s tends to run in some families more than others, so I was a little concerned about it. I didn’t worry about it, I didn’t dwell on it, but it was always kind of back there.
“Alzheimer’s tends to run in some families more than others, so I was a little concerned about it.”
Being Patient: With monoclonal antibody therapies they employ our immune systems to attack the plaque beta-amyloid plaque. I’m assuming at that time, you didn’t know if you actually even had plaques in order to go on these therapies. Is that right?
Sasse: I did not. I applied to volunteer to be screened, and that’s where they determined there were several criteria for getting [into] the study itself, and had to be over 65. You had to have no symptoms or diagnosis and went through a whole series of tests, cognitive tests, blood tests, CAT scans, [and] MRIs, but the final test was a PET scan, where they actually determined if you had this elevated level of amyloid protein in your brain. Elevated meant that some plaques had begun to form and that was the first time that I actually did that— I had plaque forming in my brain.
Being Patient: Do you mind if I asked how old you were at that point?
Sasse: I was 69. The criteria was that you had to be at least 65, and I was 69 and retired.
Being Patient: I mean, that’s pretty brave of you, Bill. Because a lot of people are afraid to understand that there may be that Hallmark. Tell me a little bit about how you found out and what that was like.
Sasse: Well, after the PET scan, I think this entailed about six visits to the Indiana University Neuroscience Center in Indianapolis. At the final visit, after the PET scan, I met with the lead doctor and his nurse. They said, “Yes, you did have the amyloid plaque in your brain,” and were an acceptable candidate for the trial.
That didn’t surprise me anyway, based on my family history. I guess I would have been surprised if I didn’t have any. But at any rate, I didn’t really spend a lot of time thinking about it didn’t weigh on me heavily or anything. I just said, “Yes, we need to do this.”
“I just said, “Yes, we need to do this.”’
Being Patient: A lot of people are interested in the trial experience. So, after you learned you were accepted, what happens next?
Sasse: Well, then you start a regimen of monthly infusions. There was some flexibility in that schedule to accommodate any travel schedules that we might have. But, anytime between three weeks and six weeks, these things would be scheduled and, ultimately, 12 per year.
So, you start out initially every four months. I would have a series of cognitive tests to determine if there had been any mental decline. You know what those tests are like, identifying shapes and repeating things, stories, shapes, and so forth, counting backward by threes from 100. Between these tests, and that was all part of it, every month, I would get an infusion, and every three or four months, I’d have this series of tests.
I’d have an MRI probably every other year. I had a couple [of] PET scans during the seven years I was in that. But that’s kind of how that initially, there was an infusion that actually took an hour to do, and then there was a one-hour waiting period to see if there were any side effects. But, after about two years or so, our nurse came in and said, “Yeah, I have a surprise today, there’s no more waiting periods.” So, that was a big deal. It cut our time and a half.
My wife was my study partner; she went with me and every four to six months, when we would meet with the doctors, they would meet with her first and get her opinion of my condition. Then they would ask her about some current events that we had done. Then I would meet with the doctor, and he would give me a series of cognitive tests and then ask me the same question about current events and see if my version agreed with hers. It always did, so that was good.
I saw that doctor probably twice a year, and then every four months, it was just a series with the administrative assistant for tests and so forth. And this was all done in Indianapolis at the IU Health Neuroscience Center.
Being Patient: Did you experience any signs of memory loss before this trial?
Being Patient: We’re getting a question from the audience from someone whose wife was also in the solanezumab trial. His wife did have some memory loss symptoms and experienced improvements while on the drug during the trial. He’s wondering if you also experienced improvements to your memory. What was it like for you? Did you notice any changes?
Sasse: I felt absolutely nothing. Throughout and now after, after 60 or 66 visits to Indianapolis for infusions. For all participants, this was going on in four countries around the world, so there were 1,100 of us total volunteers in the study. But after visit 66, it became what they call “open-label,” and everybody got the drug, whether or not they’d been getting the placebo with a drug before. It was a double-blind study.
Sasse: I did not, never did, and I won’t learn that. But, there was never any effect. I think. After it changed to open-label, I think my wife expected my ears to turn green or something, but they didn’t. There was no change. I felt nothing throughout the study.
To answer the [audience] question, I think probably the only way to know for someone like me would be with a PET scan, because solanezumab was designed to halt the progression of plaque in the brain. So, if there was no progression, I guess you would deem that success.
Being Patient: Did they give you a PET scan afterward or tell you the results of the PET scans?
Sasse: No, they did not. That would be probably my one criticism of the trial. I would have liked to have known throughout the [study]. I know that they did that scan two or three times during the course of those seven years. I would have liked to have known if there was any physical change in my brain, which the PET scan would have revealed.
“I would have liked to have known if there was any physical change in my brain, which the PET scan would have revealed.”
Being Patient: Did you try to ask for PET scan results at the end of the trial?
Sasse: I asked at the time, but I have not asked since, and I don’t know how much information they get at the test site as far as the results.
Being Patient: Yeah, I do think it’s put into a central depository somewhere. Still, that’s important to know, right? If you’re on this drug, you have the right to know whether or not it worked or not in terms of taking away the biomarker.
Sasse: Well, I would have liked to know that too. That didn’t happen.
Being Patient: How long ago now was it that you completed the trial?
Sasse: The trial was terminated last March 2023.
Being Patient: Do you know why it was terminated?
Sasse: All I know is what they said, and they said their primary and secondary endpoints were not met. So, I don’t know if there was some benefit gained by some people or not.
I know that the people that were at the test site where I went, which was just one site, there were only six of us at that site, out of 1100— but they were optimistic that it was going to be successful. I think the people at Lilly were cautiously optimistic. That’s what I was told, so that’s all I know.
Then when it’s announced that it’s a failure, that’s just kind of the end of everything.
“Then when it’s announced that it’s a failure, that’s just kind of the end of everything.”
Being Patient: Since then, there have been two FDA-approved monoclonal antibody drugs: aducanumab, branded Aduhelm, and lecanemab, which is under the brand name Leqembi. Have you talked to your doctor about those drugs? Because, in principle they work the same way, in terms of monoclonal antibody therapies.
Sasse: No, I’ve not talked to the doctors about that. I know that Lilly is expecting donanemab to be approved, and I was told that they may be coming out with a trial on a donanemab-type drug for people like me that have no diagnosis or symptoms.
Being Patient: So, you don’t feel any symptoms today like you. You feel like you’re healthy and still the same, right? How old are you?
Sasse: I’m 77.
Being Patient: That’s great. Do you know if you have a genetic link? Did you ever get genetic testing?
Sasse: I have not done that, unless that was done as part of the study that I wasn’t told. I don’t think it was. That would be the only case, and I’m pretty sure that I have not had that.
Being Patient: Looking back on your whole experience, what are some things that people should know who may be considering going into trials?
Sasse: Well, I guess my advice would be to do your own research. I think a lot of people’s very first reaction is, “Oh, don’t do that. There’s side effects.” They’re scared of what they don’t know. Most of those side effects have been mitigated before the drug trial ever comes out. There are some things, but know what you’re dealing with before you say “No.” The final decision is yours, of course.
“I think a lot of people’s very first reaction is, “Oh, don’t do that. There’s side effects.” They’re scared of what they don’t know.”
Being Patient: Did you have any side effects while you were going through the trial?
Sasse: None whatsoever, from start to finish.
Being Patient: So, you would have your infusion, and then you’d have to stay there so that they could really see how you’re doing for an hour or so, and then you’d walk away feeling absolutely fine?
Sasse: Absolutely fine. Yes, and after the first couple of years, I didn’t even stay. As soon as the infusion was over. I was out of there.
Being Patient: What was the process of infusion like for you? Tell us a little bit about the process.
Sasse: Well, they have an infusion center at the Neuroscience Center. It’s very efficient. The phlebotomist they’re really good; they don’t stab around on you trying to find their veins. I don’t think they ever missed one of mine. It’s well done, they’re professional, and they check on you during that hour.
The phlebotomist will come in and make sure that the machine is working properly. It’s the typical hang of the bag, and it’s a drip infusion. It takes an hour. This is called the A4 study, and when the A4 study started, it was 400 milliliters. Then later on, it jumped to 800, and then finally to 1600 milliliters. All three of them still took an hour to infuse.
That’s the typical needle [at] the end of the artery at your elbow. Other than the little prick of the needle, which was not much, that’s about all you feel.
Being Patient: How did you find out about the trial in the first place?
Sasse: Well, at the end of that TV show, there was the solicitation, and it referenced the National Agency on Aging. And there was some contact information there. So, I went to the National Agency on Aging, and did a little digging there on their website and found the A4 study of Lily’s. I discovered that the only test site in Indiana was in Indianapolis, and there was some contact information there.
Probably, I watched that show in, I think it was, June of 2015. In August, or about that time, I started making some inquiries. There were a couple of phone calls and a couple of emails before I was able to make a hard contact with the people in Indianapolis, but then it was pretty routine after that.
After I told them my history, they invited me in for the screening process. That’s how it went. It was not difficult.
“After I told them my history, they invited me in for the screening process. That’s how it went. It was not difficult.”
Being Patient: Do you pay attention to lifestyle factors for prevention?
Sasse: My wife and I try to eat healthily. We’ve done that for years. We have a big garden in the summertime and all that stuff. We try to exercise. A couple of years ago, we got electric assist bikes; we’ve ridden over 3000 miles, so we love doing that. We keep our minds active. We read, play puzzles, and do games from time to time and try to do all the things you’re supposed to do, and we try not to be stupid on the things you’re not supposed to be.
Being Patient: All right. Well, thank you so much, Bill, for sharing your experience. We get so many questions from people who don’t really know what to make of the MAB trials, so what better way to talk about it than with someone who has had that firsthand experience? We appreciate you really being open and sharing with us.
Sasse: Well, thank you very much for having me, and thank you for all you do for Being Patient. You’re a blessing to a lot of people out there seeking information.
Katy Koop is a writer and theater artist based in Raleigh, NC.