Bill Sasse: An Insider’s Account of the Alzheimer’s Solanezumab Drug Trial

The method of discovering new remedies for Alzheimer’s illness is one in every of trial and error — and each “failed” trial generates invaluable new knowledge to assist researchers and drug builders perceive what works, what doesn’t, and why. One such trial was solanezumab, which in March of 2023 finally did not hit its benchmarks in slowing cognitive decline, and the trial was discontinued. Nonetheless, with a number of contributors and years of analysis, there are nonetheless some insights to be gained on the scientific trial course of and the way monoclonal antibody medication, or MAB medication, are developed. 

Invoice Sasse, whose father died of Alzheimer’s, had the distinctive expertise of collaborating on this scientific trial with out having any signs of cognitive decline. A military veteran, retired enterprise proprietor, grandparent, and a local of Columbus, Indiana, he joined the trial after being impressed by a documentary about Glen Campbell selling the trial, asking himself, “Why not, me?”

Along with his spouse as his trial associate, he participated within the solanezumab trial for eight years earlier than it was introduced that the scientific trial had failed. He has participated in panels with Eli Lilly on his expertise with the trial. 

Sasse joins Being Affected person Founder Deborah Kan to debate his expertise with the trial and recommendation for folks fascinated about collaborating in Alzheimer’s analysis. Learn or watch the total dialog beneath. 

Being Affected person: How did you discover out concerning the trial, and which one had been you in?

Invoice Sasse: I came upon concerning the trial by watching the TV particular that Eli Lilly sponsored in 2015. It was all concerning the journey of Glen Campbell. He had been identified with Alzheimer’s, and so they had agreed to do one ultimate tour. He and his household agreed to let the progress of the illness be documented all through this tour. 

It was initially deliberate for under 15 dates, however then it was so well-liked, they performed for about 120. On the finish, there was a solicitation for a drug trial of Eli Lilly’s new Alzheimer’s experimental drug, solanezumab. 

I had some historical past in my household of dementia and Alzheimer’s, my prolonged household, and extra intently with my father and my grandmother. I had by no means actually thought of being in a drug trial, however after watching this, I believed possibly I ought to pursue it. I couldn’t give you any good causes to not, so I did. 

“I had by no means actually thought of being in a drug trial, however after watching this, I believed possibly I ought to pursue it. I couldn’t give you any good causes to not, so I did. “

Being Affected person: Had you been identified, or had been you experiencing cognitive difficulties?

Sasse: I hadn’t. I wasn’t conscious of any cognitive issues, and I didn’t know something about my private scenario. I simply knew that I had some within the household. I suppose that thought was at all times type of lingering again there that I could also be confronted with that sometime myself.

Being Affected person: What number of relations had been identified at that time with Alzheimer’s?

Sasse: Nicely, I don’t know. My grandmother was one in every of 10 youngsters, and I do know a number of of these siblings suffered from dementia. Whether or not it was referred to as Alzheimer’s again then, I don’t know. [With] my grandmother, they referred to as that “hardening of the arteries.” My father was identified in 1992, and his signs had been no totally different than my grandmother’s and several other of these others. 

These had been all 40 or 50 years in the past, with the siblings, and so I believe in the event that they had been round as we speak, they in all probability name it Alzheimer’s, however at any charge, I knew that my father was identified. Alzheimer’s tends to run in some households greater than others, so I used to be somewhat involved about it. I didn’t fear about it, I didn’t dwell on it, but it surely was at all times type of again there.

“Alzheimer’s tends to run in some households greater than others, so I used to be somewhat involved about it.”

Being Affected person: With monoclonal antibody therapies they make use of our immune programs to assault the plaque beta-amyloid plaque. I’m assuming at the moment, you didn’t know in case you really even had plaques with the intention to go on these therapies. Is that proper?

Sasse: I didn’t. I utilized to volunteer to be screened, and that’s the place they decided there have been a number of standards for getting [into] the examine itself, and needed to be over 65. You needed to haven’t any signs or analysis and went by an entire collection of exams, cognitive exams, blood exams, CAT scans, [and] MRIs, however the ultimate take a look at was a PET scan, the place they really decided in case you had this elevated degree of amyloid protein in your mind. Elevated meant that some plaques had begun to kind and that was the primary time that I really did that— I had plaque forming in my mind.

Being Affected person: Do you thoughts if I requested how outdated you had been at that time?

Sasse: I used to be 69. The standards was that you just needed to be a minimum of 65, and I used to be 69 and retired. 

Being Affected person: I imply, that’s fairly courageous of you, Invoice. As a result of lots of people are afraid to grasp that there could also be that Hallmark. Inform me somewhat bit about the way you came upon and what that was like. 

Sasse: Nicely, after the PET scan, I believe this entailed about six visits to the Indiana College Neuroscience Middle in Indianapolis. On the ultimate go to, after the PET scan, I met with the lead physician and his nurse. They stated, “Sure, you probably did have the amyloid plaque in your mind,” and had been a suitable candidate for the trial.

That didn’t shock me anyway, based mostly on my household historical past. I suppose I’d have been stunned if I didn’t have any. However at any charge, I didn’t actually spend a whole lot of time occupied with it didn’t weigh on me closely or something. I simply stated, “Sure, we have to do that.” 

“I simply stated, “Sure, we have to do that.”’

Being Affected person: Lots of people have an interest within the trial expertise. So, after you discovered you had been accepted, what occurs subsequent?

Sasse: Nicely, then you definitely begin a routine of month-to-month infusions. There was some flexibility in that schedule to accommodate any journey schedules that we’d have. However, anytime between three weeks and 6 weeks, this stuff can be scheduled and, finally, 12 per 12 months. 

So, you begin out initially each 4 months. I’d have a collection of cognitive exams to find out if there had been any psychological decline. You realize what these exams are like, figuring out shapes and repeating issues, tales, shapes, and so forth, counting backward by threes from 100. Between these exams, and that was all a part of it, each month, I’d get an infusion, and each three or 4 months, I’d have this collection of exams. 

I’d have an MRI in all probability each different 12 months. I had a pair [of] PET scans in the course of the seven years I used to be in that. However that’s type of how that originally, there was an infusion that truly took an hour to do, after which there was a one-hour ready interval to see if there have been any unwanted side effects. However, after about two years or so, our nurse got here in and stated, “Yeah, I’ve a shock as we speak, there’s no extra ready intervals.” So, that was an enormous deal. It minimize our time and a half. 

My spouse was my examine associate; she went with me and each 4 to 6 months, once we would meet with the docs, they’d meet together with her first and get her opinion of my situation. Then they’d ask her about some present occasions that we had finished. Then I’d meet with the physician, and he would give me a collection of cognitive exams after which ask me the identical query about present occasions and see if my model agreed with hers. It at all times did, in order that was good. 

I noticed that physician in all probability twice a 12 months, after which each 4 months, it was only a collection with the executive assistant for exams and so forth. And this was all finished in Indianapolis on the IU Well being Neuroscience Middle.

Being Affected person: Did you expertise any indicators of reminiscence loss earlier than this trial?

Sasse: None. 

Being Affected person: We’re getting a query from the viewers from somebody whose spouse was additionally within the solanezumab trial. His spouse did have some reminiscence loss signs and skilled enhancements whereas on the drug in the course of the trial. He’s questioning in case you additionally skilled enhancements to your reminiscence. What was it like for you? Did you discover any adjustments?

Sasse: I felt completely nothing. All through and now after, after 60 or 66 visits to Indianapolis for infusions. For all contributors, this was occurring in 4 nations world wide, so there have been 1,100 of us whole volunteers within the examine. However after go to 66, it grew to become what they name “open-label,” and everyone received the drug, whether or not or not they’d been getting the placebo with a drug earlier than. It was a double-blind examine.

Being Affected person: Did you discover out in case you had been on the placebo or not?

Sasse: I didn’t, by no means did, and I received’t study that. However, there was by no means any impact. I believe. After it modified to open-label, I believe my spouse anticipated my ears to show inexperienced or one thing, however they didn’t. There was no change. I felt nothing all through the examine. 

To reply the [audience] query, I believe in all probability the one technique to know for somebody like me can be with a PET scan, as a result of solanezumab was designed to halt the development of plaque within the mind. So, if there was no development, I suppose you’ll deem that success. 

Being Affected person: Did they provide you a PET scan afterward or let you know the outcomes of the PET scans? 

Sasse: No, they didn’t. That will be in all probability my one criticism of the trial. I’d have preferred to have identified all through the [study]. I do know that they did that scan two or 3 times in the course of the course of these seven years. I’d have preferred to have identified if there was any bodily change in my mind, which the PET scan would have revealed.

“I’d have preferred to have identified if there was any bodily change in my mind, which the PET scan would have revealed.”

Being Affected person: Did you attempt to ask for PET scan outcomes on the finish of the trial? 

Sasse: I requested on the time, however I’ve not requested since, and I don’t understand how a lot data they get on the take a look at website so far as the outcomes. 

Being Affected person: Yeah, I do suppose it’s put right into a central depository someplace. Nonetheless, that’s vital to know, proper? Should you’re on this drug, you may have the suitable to know whether or not or not it labored or not by way of taking away the biomarker. 

Sasse: Nicely, I’d have preferred to know that too. That didn’t occur. 

Being Affected person: How way back now was it that you just accomplished the trial?

Sasse: The trial was terminated final March 2023.

Being Affected person: Are you aware why it was terminated?

Sasse: All I do know is what they stated, and so they stated their major and secondary endpoints weren’t met. So, I don’t know if there was some profit gained by some folks or not. 

I do know that the people who had been on the take a look at website the place I went, which was only one website, there have been solely six of us at that website, out of 1100— however they had been optimistic that it was going to achieve success. I believe the folks at Lilly had been cautiously optimistic. That’s what I used to be informed, in order that’s all I do know.

Then when it’s introduced that it’s a failure, that’s simply type of the top of all the things.

“Then when it’s introduced that it’s a failure, that’s simply type of the top of all the things.”

Being Affected person: Since then, there have been two FDA-approved monoclonal antibody medication: aducanumab, branded Aduhelm, and lecanemab, which is below the model identify Leqembi. Have you ever talked to your physician about these medication? As a result of, in precept they work the identical manner, by way of monoclonal antibody therapies.

Sasse: No, I’ve not talked to the docs about that. I do know that Lilly is anticipating donanemab to be accredited, and I used to be informed that they could be popping out with a trial on a donanemab-type drug for folks like me that haven’t any analysis or signs.

Being Affected person: So, you don’t really feel any signs as we speak such as you. You are feeling such as you’re wholesome and nonetheless the identical, proper? How outdated are you?

Sasse: I’m 77.

Being Affected person: That’s nice. Are you aware when you’ve got a genetic hyperlink? Did you ever get genetic testing?

Sasse: I’ve not finished that, until that was finished as a part of the examine that I wasn’t informed. I don’t suppose it was. That will be the one case, and I’m fairly positive that I’ve not had that.

Being Affected person: Trying again in your complete expertise, what are some issues that folks ought to know who could also be contemplating going into trials?

Sasse: Nicely, I suppose my recommendation can be to do your personal analysis. I believe lots of people’s very first response is, “Oh, don’t try this. There’s unwanted side effects.” They’re afraid of what they don’t know. Most of these unwanted side effects have been mitigated earlier than the drug trial ever comes out. There are some issues, however know what you’re coping with earlier than you say “No.” The ultimate determination is yours, after all.

“I believe lots of people’s very first response is, “Oh, don’t try this. There’s unwanted side effects.” They’re afraid of what they don’t know.”

Being Affected person: Did you may have any unwanted side effects when you had been going by the trial?

Sasse: None in any respect, from begin to end. 

Being Affected person: So, you’ll have your infusion, and then you definitely’d have to remain there in order that they may actually see the way you’re doing for an hour or so, and then you definitely’d stroll away feeling completely fantastic? 

Sasse: Completely fantastic. Sure, and after the primary couple of years, I didn’t even keep. As quickly because the infusion was over. I used to be out of there. 

Being Affected person: What was the method of infusion like for you? Inform us somewhat bit concerning the course of.

Sasse: Nicely, they’ve an infusion heart on the Neuroscience Middle. It’s very environment friendly. The phlebotomist they’re actually good; they don’t stab round on you looking for their veins. I don’t suppose they ever missed one in every of mine. It’s nicely finished, they’re skilled, and so they verify on you throughout that hour. 

The phlebotomist will are available in and ensure that the machine is working correctly. It’s the everyday hold of the bag, and it’s a drip infusion. It takes an hour. That is referred to as the A4 examine, and when the A4  examine began, it was 400 milliliters. Then afterward, it jumped to 800, after which lastly to 1600 milliliters. All three of them nonetheless took an hour to infuse. 

That’s the everyday needle [at] the top of the artery at your elbow. Aside from the little prick of the needle, which was not a lot, that’s about all you’re feeling.

Being Affected person: How did you discover out concerning the trial within the first place?

Sasse: Nicely, on the finish of that TV present, there was the solicitation, and it referenced the Nationwide Company on Getting older. And there was some contact data there. So, I went to the Nationwide Company on Getting older, and did somewhat digging there on their web site and located the A4 examine of Lily’s. I found that the one take a look at website in Indiana was in Indianapolis, and there was some contact data there. 

In all probability, I watched that present in, I believe it was, June of 2015. In August, or about that point, I began making some inquiries. There have been a few cellphone calls and a few emails earlier than I used to be in a position to make a tough contact with the folks in Indianapolis, however then it was fairly routine after that. 

After I informed them my historical past, they invited me in for the screening course of. That’s the way it went. It was not tough.

“After I informed them my historical past, they invited me in for the screening course of. That’s the way it went. It was not tough.”

Being Affected person:  Do you take note of way of life elements for prevention? 

Sasse: My spouse and I attempt to eat healthily. We’ve finished that for years. We’ve got an enormous backyard within the summertime and all that stuff. We attempt to train. A few years in the past, we received electrical help bikes; we’ve ridden over 3000 miles, so we love doing that. We maintain our minds lively. We learn, play puzzles, and do video games every now and then and attempt to do all of the belongings you’re speculated to do, and we attempt to not be silly on the belongings you’re not speculated to be.

Being Affected person: All proper. Nicely, thanks a lot, Invoice, for sharing your expertise. We get so many questions from individuals who don’t actually know what to make of the MAB trials, so what higher technique to speak about it than with somebody who has had that firsthand expertise? We recognize you actually being open and sharing with us. 

Sasse: Nicely, thanks very a lot for having me, and thanks for all you do for Being Affected person. You’re a blessing to lots of people on the market searching for data.

Katy Koop is a author and theater artist based mostly in Raleigh, NC.