 Joining us to discuss your health tonight is Dr. Paul Fishman, neurologist at the University of Maryland Medical Center and professor of neurology at the University of Maryland School of Medicine. Doctor, it's good to see you again. Tell us about this new drug that was just approved by the FDA. Well, thanks Jeff for having me. And it really is exciting to talk about Lacanimab, which is the first drug to have full FDA approval to try to stop the progressive worsening of Alzheimer's disease. And even though its effects are modest, it really is a step toward changing the biology of Alzheimer's disease where there have been many studies before that have never been successful in this. It really is the culmination probably about an idea that's been around for more than 20 years and there have been many studies that have been unsuccessful and gradually this idea that one could give an antibody, a monoclonal antibody and try to remove the toxic abnormal protein that actually Alzheimer noticed 100 years ago but has only been biologically known, biochemically known for about the last 30 or 40 years. And the question is, could you remove that from the brain? And if you could, could you actually improve patients' long-term outcome with Alzheimer's disease? That idea that's been around for a long time looks like it has validity. Doctor, you said the effects are modest. How modest are they? Well, patients who received this drug for about a year and a half compared to those who were infused with placebo did about 30% better than expected. So when we look at several aspects, how they did in day-to-day life, their ability to go about their own business without help, as well as cognitive testing, again, there was about a spread of about 30% difference between after 18 months. So that's small, but that's not in, you know, it's still significant. And the biggest issue, of course, we won't know for years is that will that difference continue or will it expand over the next one, two or three years? Since, sadly, we all know about Alzheimer's disease, a disease that progresses relatively slowly, but with accumulating issues over years. So will that 30% turn into 40% and 50% and can we postpone the disability of Alzheimer's disease? Have people stay in their homes longer? Have people avoid institutionalization like assisted living or nursing homes? And if that is real and expands, as I mentioned, it's kind of the first step toward really turning the clock back on Alzheimer's disease. So if it's not a cure and it's not reversing the decline, it may be slowing it a bit. Does that mean it's most appropriate for a patient who's in the earliest stages of the disease? That's correct. And this was anticipated from earlier studies. And that's the only patients who are really studied at this point. Patients who had conditions we wouldn't even call Alzheimer's disease 10 years ago. They would be called having mild cognitive impairment. They basically can do all their activities of daily living, but they have interference with memory, with word finding, with calculations. That makes some impact on them, as well as patients with traditional early Alzheimer's disease, which may need some assistance, but again, fairly independent. So again, this is for patients very early in the course of Alzheimer's disease. Let me remind our viewers if you have a question about this new medication or Alzheimer's disease in general, give us a call at the number on the screen or send an email to livequestions at mpt.org. Doctor, this is given by infusion, I think. Tell me more about the process, the side effects, that sort of thing. Well, it's complicated to give. As a matter of fact, at the University of Maryland, we spent a good part of last Friday planning all of the things we need to eventually give this drug. So it is given by infusion, and unlike a lot of its partner drugs, it's given by infusion every two weeks. So you have to have an infusion center. They have to be monitored. A fair number of patients could have an infusion reaction, an allergic or like reaction, usually not severe. But again, patients have to be monitored by a nurse. All patients have to have a special form of brain scan looking for deposits of amyloid. Since in the older days, a lot of times we thought a patient had Alzheimer's, but it really turned out to be another form of dementia. And it's only patients who actually have Alzheimer's disease who have amyloid deposition. There's no point getting a drug, taking a drug to remove amyloid if you don't have that. So patients will need a special form of nuclear medicine scan that really needs to be read by an expert to say, definitively, there's amyloid here, that this is a patient who's a good candidate. They have to have cognitive testing to really measure, are they in the early stages of Alzheimer's disease or not too advanced that they would still qualify? And also to measure, is their cognition worsening during the course of this or being stable? They also need to be monitored for the most significant side effect of this class of medications, which can cause, in particular, some degree of brain swelling, and even at some point, some degree of small brain bleeding. And again, a sophisticated, well-trained radiologist has to look at MRI scans both beforehand and during the treatment process to make sure that there aren't risk factors, like a small amount of bleeding into the brain to begin with, because patients with Alzheimer's disease can have small brain hemorrhages. You would never want to give that type of patient this type of treatment. And to monitor it, if patients develop brain swelling or brain hemorrhages, they need to be withdrawn from the medication. So the monitoring process is intense. Let's take a phone call from Frederick County. This is Peter. Peter, thanks for the call. Go ahead. Yeah, with all the side effects, wouldn't it just be worthwhile to key in on the early, early Alzheimer person, 50 years old, and it's shown that they do have Alzheimer's disease because of, you know, they had a PET scan of, you know, to show that it definitely was Alzheimer's and not another type of dementia. That person has many, many years instead of that 80-year-old who may have multiple medical problems and the side effects, you have to look at the risk versus the benefit. Peter, thank you very much for the phone call. Dr, on that point is one of the things you would look at in a younger potential patient, whether there's family history. Well, particularly with early onset, family history is a bit of predictor, particularly with those early onset. And there are a few genes that have been identified, but there are two aspects to those questions. One, there are side effects, but in general, they're mild. It is actually very few of the patients had to be taken off the drug because of the side effects. And that's because the patients were well monitored. And through previous studies, they know that this particular dose usually did not have significant side effects. The most common one was basically just a headache that would go away. And it's actually very difficult and sometimes not particularly practical with current technology to identify patients before they have any symptoms. Jeff's right that if they have a strong family history and then identified with risk factors, those patients can be done. But these PET scans, the idea of doing them throughout the population, they cost between $3,000 and $5,000. Should everyone at age 50 have a PET scan? That's an experimental question. And the question is if you went to these very early patients, would they do any better? Would you prevent, would the outcome be any different than the group that they're using now? And that's a scientific question that isn't yet resolved. And the cost of the PET scan gets to an email from a viewer who wants to know what's the cost per month of the drug and is it going to be covered by insurance? I think it is covered by Medicare. Medicare has agreed to cover it and that's the advantage of traditional, not any special form of approval. Medicare will cover the drug. It's between $20,000 and $25,000 a year. But then you have these added costs of the PET scan of multiple MRIs, the cost of the infusion. But again, in general, that's going to be covered by Medicare. Medicare traditionally had not covered the PET scans because they said, why bother? There's no change in treatment whether or not you have a positive or negative PET scan. That's an experimental question. But now that PET scans are tied to a FDA approved treatment, Medicare is seriously considering of reversing that position. So even in the future, the PET scans may be covered as well. There was news recently that Maryland, in particular Baltimore City, Prince George's County are hot spots for the incidence of Alzheimer's disease. Is that the case? And what would explain that? Well, the study you're talking about is an interesting study. No patients in the state of Maryland were examined in this study. This was taking a profile that they developed from studies of patients in Chicago and applying it to census demographic information throughout the country. So none of the patients outside of Chicago were ever examined. And what they found, which are things that are expected. If you have a lot of the very old, so they looked at everybody over age 65, but if your population has lots of people in the 80s or over 85 or over 90, you're going to have a lot of Alzheimer's disease. African Americans sadly do have a fairly high prevalence. And that's because they also carry risk factors for vascular disease, such as diabetes and hypertension. And the general rule of thumb is that all bad things that affect the brain are additive. So if you have both traditional Alzheimer's pathology, along with blood vessel changes, you're more likely to have clinically detectable Alzheimer's disease. So those are some of the factors that they use to come up with this figure. Yes, we're the leaders, but there are plenty of other places that are closed. We were 12.9%, then the Bronx, where I'm actually from was 12.8%. So there are a lot of hotspots in the country where, again, age, prevalence of hypertension, diabetes, uh, educational level, and also socioeconomic status. They're all risk factors for not so great health care and also not so great brain health and prevalence of Alzheimer's disease. Let's get one more phone call from Montgomery County. This is Joe. Joe, thank you for calling. Go ahead. Hi. Yes, I wondered if PET scans have the same problem with MRIs with people with metal implants? Thanks very much. No, they have a totally different basis. So metal has no, uh, they're, they're an injection of a radioactive isotope and they're looking for its binding within the brain. So it does, it's not, it doesn't have any of the principles of MRI, although there are now fancy studies that can do both at once. You, um, you mentioned the, uh, the incidence of diabetes, hypertension. If, if somebody wants to lower their odds today, would keeping blood pressure and blood sugar under control be a good starting point? And, and how's it compared maybe to this new drug? Well, it all depends on when you start. If you start at a relatively young age, it is a very powerful risk reduction factor. So all the things that are heart healthy are basically brain healthy as well, which means physical activity, keeping the diabetes under control, keeping your weight under control, uh, control of hypertension. Those things and those have been studying intensively over decades. And if you do that over 10, 20 years, uh, that even outweighs the power of, uh, many of the genetic factors. Uh, but the question is the longer you wait, the more these vascular changes accumulate, uh, the harder they are to reverse. So they're always, uh, important to control, but you're better off controlling them as, as early as possible. If, uh, somebody watching, uh, thinks they may be a patient or maybe a candidate for this wants to learn more, maybe a family member, um, is this going to be at tertiary care big hospitals like Maryland? Uh, very likely. Just as I mentioned, uh, not every center is even capable. They're called positron emission tomography. So they, uh, so positron doesn't last very long. So you have to have the capability to do pet scans. You have to have the experience to interpret them. And the monitoring of the MRI, uh, even in Maryland, I'm afraid we're going to have to leave it there. Dr. Paul Fishman of the University of Maryland Medical Center. Thank you very much. Thanks for having me. Your health segments are a co-production of Maryland public television and the University of Maryland medical system.