U-M Alzheimer's prevention study looking for more participants
Cathy Shafran: This is 89 one WEMU FM. I'm Cathy Shafran. And today we're looking at the latest on a new Alzheimer's drug. The U.S. Food and Drug Administration this month granted accelerated approval for an Alzheimer's disease drug. The studies for the drug showed some promising biological effects of removal of the brain's amyloid buildup that occurs in the disease. It is called a promising breakthrough. But not all in the field are pinning all their hopes on this drug. It is called Lecanemab. Dr. Judy Heidebrink is a neurologist and clinical core lead of the Michigan Alzheimer's Disease Center at University of Michigan Health. She's looking at this drug with caution, noting that it's no way a cure and also carries some serious side effects. Dr. Heidebrink, thanks so much for joining us.
Dr. Judy Heidebrink: Thank you for inviting me.
Cathy Shafran: Okay. So, I'm assuming that you work with Alzheimer's patients at various stages of the disease. Are there any of your patients for whom you'd recommend the drug?
Dr. Judy Heidebrink: Well, first, it's important to note that this drug has really been studied in individuals with early symptoms of Alzheimer's disease. So individuals who are either experiencing some memory changes but still independent in daily activities or just showing some mild or difficulties with their early symptomatic stage. So we wouldn't consider anyone with more advanced symptoms because it hasn't been studied in that population.
Cathy Shafran: Mm hmm. How do you treat patients currently with Alzheimer's symptoms?
Dr. Judy Heidebrink: Yes, I currently treat patients with Alzheimer's across the spectrum of symptom severity.
Cathy Shafran: And now that it has been granted accelerated approval is it's a drug that you would consider using for them.
Dr. Judy Heidebrink: I will absolutely have a discussion with individuals who I think are eligible, and that would be individuals who really match the type of persons in whom the drug has been studied. Obviously, we need to wait to hear more about whether it's going to be offered at the University of Michigan. It goes through a review process because it's not a simple drug that you pick up at your pharmacy. It is an intravenous medication infused every two weeks. So we need to make sure the infrastructure is in place to be able to offer it safely. And we're also waiting on further review by insurer insurers in particular.
Cathy Shafran: For the layperson, can you explain how it's intended to work and what impact it's supposed to have?
Dr. Judy Heidebrink: Sure. Looking at a map is an antibody against the amyloid protein that builds up abnormally in the brain when someone has Alzheimer's disease. So it's given as an infusion gets into the brain, binds to that amyloid that's building up, allows the brain's immune mechanisms to remove the amyloid. That effect is very clear, and that's the effect by which the FDA approved the drug because of its biological effect, its ability to remove that brain amyloid in individuals in the early symptomatic stage of Alzheimer's. The question has always been, does that help individuals as it does it help their symptoms as they're experiencing the progressive decline of this this terrible disease? And although the clinical data wasn't reviewed extensively by the FDA, there has been a large publication showing that individuals who received the treatment, a biweekly infusion compared to those receiving the placebo, experienced less decline. So not a cure didn't halt progression, but less decline over the eight months of the trial.
Cathy Shafran: So, at what stage in the disease would you need to catch somebody to make this a useful drug?
Dr. Judy Heidebrink: Yeah, for the information we have right now would be individuals who are either noticing changes in their memory and have documented lower than expected scores on memory or other thinking tests for their age, but are still either functioning independently with compensatory strategies or just needed some mild assistance. So we would consider this a mild dementia stage or an earlier stage called mild cognitive impairment. So, that would be the symptomatic stage. But we also need to know that individuals with those types of symptoms have amyloid building up in the brain. So in this study, individuals underwent what was called biomarker characterization, typically a brain scan that specifically looks for the amyloid buildup. Right now, those scans are technically available. The tracers are out there, but they aren't covered by insurance companies. So we'll have to know if this drug becomes available. Will those scans also be covered by insurers?
Cathy Shafran: Now, if somebody is listening and they feel that they have a loved one who is exhibiting these preliminary symptoms of Alzheimer's, and they say to themselves, perhaps I want to get involved, I would like to have my loved one be able to at least try to to minimize the effects as early as possible. What would I do?
Dr. Judy Heidebrink: I think the starting point would be recommending that this person and their family speak with their physician to help understand first, do they have what appears to be early symptoms of Alzheimer's disease? Not all memory loss. As we age is due to Alzheimer's disease, there can be many other causes that would need two completely different types of treatments or intervention. So the initial point, regardless of considering this particular therapy, would be to get a better understanding of what the underlying cause is, what stage they might be at, so the appropriate therapies can be recommended.
Cathy Shafran: And, at that point, is it available anywhere in the state of Michigan currently?
Dr. Judy Heidebrink: I believe that it is in the process of being manufactured since the FDA approval was quite recent and I haven't heard yet whether institutions that have a review process similar to ours have weighed in yet about whether it will be offered. So, we'll have to stay tuned.
Cathy Shafran: Okay. In Washtenaw County, at this point, it hasn't been authorized. Is that correct?
Dr. Judy Heidebrink: Correct. It's going through the review process at the University of Michigan.
Cathy Shafran: I know you you also have some reservations about the drug as well. Is that correct?
Dr. Judy Heidebrink: That's correct. We do know there are side effects with this drug. The most common side effect actually was what's called an infusion reaction. This typically happened with the very first time an individual received the infusion of looking a MAB and to be similar to almost like a flu like reaction with shaking or chills or aches. It was about a quarter of individuals experienced some level of infusion reaction. But typically, this was mild and either didn't occur with subsequent infusions or could be treated with simple over-the-counter types of premedications like acetaminophen, for example. So, that was the most common side effect. But a more serious, though less common side effect was either swelling or bleeding within the brain, which appears to be a consequence of the antibody helping to remove the amyloid. In a percentage of individuals, they can experience either swelling or bleeding, often does not have any associated symptoms, but can be detected by careful monitoring through brain scans like MRI scans and depending on the severity, that drug may need to be halted temporarily or in some cases permanently. So, that's something that every individual should hear about the risks of that and understand the safety monitoring that's needed to look for that.
Cathy Shafran: When you look at that data that shows the side effects, some serious side effects, and does it stop you from being encouraged to use it in the future?
Dr. Judy Heidebrink: Well, it makes me cautious. And I think we have to, as with any treatment, balance, risks and benefits. But we do know when they looked at the clinical measures and evaluated overall, how is this person doing that takes into account both the potential benefits and if they were experiencing side effects? So, on balance, it looks like individuals receiving this drug experienced less decline and that's taking those side effects into account.
Cathy Shafran: And so, at this stage, I'll repeat the question that we started with. If you have a patient that presents with early stage of forgetfulness, they have been tested and determined that it is in fact Alzheimer's. What do you recommend at this point?
Dr. Judy Heidebrink: Yeah, and in fact, that's exactly the person that I would have a careful discussion with what we've just talked about, what the expected benefit is, what the expected risk, whether there's anything about their situation that modify, whether there's likely a greater risk or lesser chance of benefit, and so that we can come to make the best decision possible. I don't think everyone is going to make the same decision in the same circumstances in terms of just the logistics coming in for infusions every two weeks versus people say, I'd like to do anything. The chance of maintaining my independence longer is worth any of those logistical burdens.
Cathy Shafran: When you look at it, though, do you see this is the beginning of a future solution?
Dr. Judy Heidebrink: Absolutely. I would say this is not a miracle, but clearly a breakthrough that we really are entering the avenue of what we call disease, modifying therapy therapies that really directly target the underlying pathology, the buildup of those plaques and tangles, and change the trajectory of someone's course who's experiencing this disease.
Cathy Shafran: And so, if somebody were to ask you can actually prevent symptoms of Alzheimer's, you would reply.
Dr. Judy Heidebrink: I would say, that's an excellent question, because what I've been talking about so far is, again, the information we have from individuals who are already experiencing early symptoms. But one question would be if this treatment slows things down, could you give it to someone at risk and prevent the emergence of Alzheimer's symptoms in someone who might be at risk based on their age, genetic factors or family history? And that actually is exactly the question that is being addressed in an ongoing study using this very same compound as a prevention for Alzheimer's symptoms. So, that's called the AHEAD study. And we are one of the participating sites at the University of Michigan. So, I can't answer that question yet. But give us a few years because these are long studies. People don't develop symptoms overnight, but hopefully we'll know whether it could be used as a prevention therapy as well.
Cathy Shafran: So, it's a hope, but not the cure.
Dr. Judy Heidebrink: Exactly.
Cathy Shafran: We have been speaking with Dr. Judy Heidebrink, a neurologist and clinical co-leader of the Michigan Alzheimer's Disease Center at the University of Michigan Health, commenting on the newly granted Alzheimer disease drug, Lecanemab. I'm Cathy Shafran. This is 89 one WEMU from Ypsilanti.
This is alink to UM Alzheimer's research and studies.
This is a linkto the AHEAD study on Alzheimer's prevention.
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