Lecanemab (Leqembi®) and donanemab (Kisunla®) are two new FDA-approved drugs, administered intravenously, that can slow cognitive decline in people diagnosed with early-stage Alzheimer’s. While not a cure, they can slow the progression of the disease and are available at the Stony Brook Center of Excellence for Alzheimer’s Disease, one of only 10 such centers in New York State and the only one on Long Island.
Learn how these infusion drugs work, and how to find out if you or a loved one qualify for treatment, while also learning about other services, resources and more that Stony Brook Medicine has to offer to help Long Island’s aging population.
The Experts
What You’ll Hear in This Episode
- 00:00 Opening and Introductions
- 1:52 Therapies for patients with Alzheimer’s disease – Lecanemab and Donanemab
- 3:19 Assessment at Stony Brook
- 4:00 What does plaque do to the brain?
- 5:00 Medications
- 6:55 Signs and when to get a cognitive assessment
- 7:30 Early Stage Alzheimer’s
- 8:55 Aging population and the increase in patients diagnosed with Alzheimer’s
- 10:00 The value of an academic medical center
- 12:40 Treatment criteria
- 13:25 Prevalence in men v. women and genetic predisposition
- 14:30 The Stony Brook Center for Healthy Aging (CHA)
- 16:08 Therapies administered at Stony Brook
- 17:45 Results, feedback and outlook
- 18:35 Advancements in therapies for Alzheimer’s disease
- 20:40 Clinical trials
- 21:25 How to be assessed and treated at Stony Brook
- 24:18 The future of treatment for Alzheimer’s disease
- 25:28 Closing Remarks
Full Transcript
00:00 Opening and Introductions
Announcer
Welcome to Healthcast, where leaders and experts from Stony Brook Medicine come together to discuss a range of topics from leadership and strategic planning to patient care and the inner workings of a successful health care system.
Timothy Brown
Welcome to Healthcast, where we have some exciting news on the fight against Alzheimer’s. We’re proud to be the first or one of the first on Long Island to offer new FDA-approved infusion treatments that’s giving hope to patients and families.
This innovative therapy targets the underlying biology of the disease, not just the symptoms. And it’s part of our growing commitment to advanced compassionate brain health care. It’s another way Stony Brook is leading the way, close to home.
Now, I’ve got two experts joining me today. And Jolene, you drew the short straw – you had to sit next to me. So we’re going to start with you. If you’ll just introduce yourself to our audience and tell us a little bit about what you do here at Stony Brook.
Jolene Knight, NP
Good morning. My name’s Jolene Knight. I’m one of the nurse practitioners in the Center of Excellence of Alzheimer’s Disease. So my role is to evaluate patients, see if they have any Alzheimer’s disease dementia, and treat them appropriately.
Nikhil Palekar, MD
Hi. Good morning. And it’s great to be here. My name is Nikhil Palekar and I’m the director of the Center of Excellence for Alzheimer’s Disease at Stony Brook Medicine and also the director of the Alzheimer’s Disease Clinical Trials Program.
1:52 Therapies for Patients with Alzheimer’s disease – Lecanemab and Donanemab
Timothy Brown
Well, I want to say, first off, what you do is so important. And I think that any family that ever experienced the devastation of Alzheimer’s with a loved one, I think will certainly appreciate what we’re going to talk about today. It’s an incredibly cruel disease. But we do have some good news. And, you know, I was reading the intro just a moment ago, as we all heard, and we are either the first or one of the first to offer these two therapies here on Long Island.
And can you tell us a little bit about what those therapies are?
Nikhil Palekar, MD
Yeah, absolutely. So these therapies target amyloid plaque that starts to build up in the brains of patients with Alzheimer’s disease. It’s one of the key pathological features of Alzheimer’s. And in July of 2023, the FDA approved the first medication Lecanemab to target directly the amyloid plaques.
So it’s almost like a sci-fi story. The medication is given through the way in. It goes into the brain. It binds to these plaques and clears them completely out of the brain within 6 to 12 months. And that medication is called the Lecanemab and we were the first on Long Island to be able to infuse our patients with that treatment.
The next year, which was July of 2024, the second medication was approved and that was called Donanemab. And we’re also infusing medication as well. And so we are providing both these options to the community on Long Island.
Timothy Brown
Now does the second medication have a similar impact as the first?
Nikhil Palekar, MD
It does. Both medications work in the same way. They both target the amyloid plaques and help in clearing of the plaques. And in terms of the benefits or the effectiveness, the medications help to slow the progression down. They do not stop the disease, unfortunately, or reverse symptoms, but they do help to slow it down. Lecanemab slows the progression down on average by about 27 percent, whereas Donanemab slowed it down on average to about 29 percent over 18 months.
3:19 Assessment at Stony Brook
Timothy Brown
So, Jolene, tell us about your role in this whole situation and with the department. What do you do and how do you help patients?
Jolene Knight, NP
So I evaluate new patients to start with. They come in complaining of maybe some minor forgetfulness, repeating themselves or sometimes advanced dementia. And I do a cognitive assessment. I get medical history, background, family history, and then I start to run some tests, look for any organic causes by doing blood work, checking Vitamin B12 levels, vitamin D and the inflammation in the body.
And I also do an MRI of the brain. So I’m looking for any atrophy or some shrinkage or any areas that might cause their symptoms to begin. And then I go from there.
4:00 What Does Plaque Do to the Brain?
Timothy Brown
And so, Dr. Palekar was talking about the plaque. So what exactly does that, and either one of you can answer this question, but what does the plaque do to the brain?
Nikhil Palekar, MD
So the plaque starts to gradually form about 15 to 20 years before the onset of symptoms. So this is already developing in the brains of patients long before they actually present to the clinic with even the earliest signs of memory loss, for example. And what the plaque does is it accumulates in the brain and it starts to disrupt brain functioning.
It starts to disrupt the neurons or the brain cells from communicating with each other, which is essential for tasks such as retaining information, processing information, planning and organization, and attention. All of these very important cognitive tasks that we do every single day are done through a whole network of connections between various parts of the brain, and that gets disrupted due to the build up of these amyloid plaques.
5:00 Medications
Timothy Brown
And Jolene, when you do that initial assessment with people you mentioned, these are people that can be in a very early stage and some are further along. Is it a similar treatment that the patients would go through?
Jolene Knight, NP
So yes and no. Lecanemab and Donanemab are only approved for mild cognitive impairment or early onset Alzheimer’s disease. So if they’re advanced, we do have two other options of medications that we use. So it really depends on how advanced they are and what stage they are in of their disease.
Nikhil Palekar, MD
I would like to jump in on that and add to what Jolene just mentioned, this is really important for our audience to know, is that these medications are only approved for patients in the very early stages of the disease.
So as Jolene mentioned, patients who have mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s.
And why is this important? Because this is a progressive illness. And if you don’t get diagnosed early and are in the early stage, you won’t be able to receive these treatments. That’s only approved by the FDA for early stage Alzheimer’s.
Timothy Brown
Interesting. And what kind of differences do you see in patients once they start taking the medication?
Nikhil Palekar, MD
So typically, we don’t see any major changes initially. And we do follow up with some cognitive and functional evaluations at about six months and then once a year. But anecdotally, I’ve already started to hear our patients and families reporting like, wow, my dad is so much more communicative or he seems he’s less forgetful or seems like he’s functioning much better.
And these are just anecdotal reports, but they obviously are amazing to hear. And the families are, you know, very delighted to see some positive changes.
6:55 Signs and When to Get a Cognitive Assessment
Timothy Brown
I would imagine there’d be a lot of people that will be watching this and they’ll probably think, how do I know if either I have it or a family member has it, if we’re in very early stages?
Is there something that people need to look for and can they come in if they think that there is an issue and get an assessment? How does that work?
Jolene Knight, NP
So we have a mild cognitive impairment clinic now. So if you’re even noticing small changes, it’s always good to have the cognitive assessment done.
So maybe we’re repeating a little bit more. We’re misplacing our keys and are really forgetting where they are. You know, sometimes we might mispronounce a name or have difficulty getting our words out. That’s always a good idea to come and get checked out.
7:30 Early Stage Alzheimer’s
Timothy Brown
Yeah. And you mentioned early stage Alzheimer’s. What exactly does that mean? Because I think when we think of Alzheimer’s, we think of people that have fairly significant impairment. But early stage, maybe not so much.
Nikhil Palekar, MD
That’s true. And typically in early stage, patients have very mild symptoms, such as mild memory problems. They might forget, you know, the recent events or have a hard time remembering some recent conversations. But they’re functioning is relatively intact. They’re able to function at work pretty well. They’re able to function at home and that pretty much falls under the mild stage.
We, of course, have very sophisticated neurocognitive assessments that we do that also help us to categorize patients between the mild and moderate or severe stage of the disease. And so we use both information from the patients and caregivers and our own neurocognitive assessments to assess the stage of the disease.
8:55 Aging Population and the Increase in Patients Diagnosed with Alzheimer’s
Timothy Brown
You know, our population is aging and in particular here on Long Island, we’re seeing a lot of the demographics show that the population on Long Island is aging.
So is that, I’m assuming but I don’t want to make an assumption here, but is that causing more of an issue with this group? Because most folks with Alzheimer’s tend to be older. So are you seeing more patients because of that?
Jolene Knight, NP
Yes, I believe so. We have had an increase in the amount of patients who are diagnosed with Alzheimer’s disease.
Nikhil Palekar, MD
And Long Island actually happens to be in New York State, the second largest area of population with 65 and older, the first being New York City. And New York State overall has the second highest proportion with Alzheimer’s in the country.
Timothy Brown
Oh wow. I did not realize that.
Nikhil Palekar, MD
So, yeah, and as you said, the population is aging and the population, especially in the age group of 65 and older, is rapidly aging and is going to double in the next 20 years. So we’re looking at, unfortunately, a lot more patients who are going to show signs of memory problems or other cognitive issues and potentially have a diagnosis of Alzheimer’s disease.
10:00 The Value of an Academic Medical Center
Timothy Brown
You know, I think that, again, to me that’s so important because this is what I think sets Stony Brook apart from most health systems and health care providers. We are an academic medical center and we are also really good at working together across the various areas of the institution. And, you know, this is such important work. And the collaboration to me is just so gratifying to see.
Nikhil Palekar, MD
Yeah. And it’s a lot of collaboration. I mean, to set up these infusions is no easy task. It took us about 2 to 4 months to get all the players together because you have the clinicians on board who are going to be prescribing the medication, the experts in the field. Then you need to work with the infusion center, which is our MART center and they have been absolutely fantastic. And you need to work with the pharmacy to procure the medication. You need to work with the neuroradiologists to do the MRI’s that are needed for these treatments. And so there’s a whole team effort through various different departments and divisions that have to come together to make this happen.
Timothy Brown
Well, and again, I think that’s kind of the beauty here and the strength. At a place like this, we have such talented people like the two of you. We can take care of the really basic things, but also the very, very complex things too. And you don’t have to go someplace else. And it just makes it so much easier.
Nikhil Palekar, MD
So my goal when these medications were going to come out was to create a hub at Stony Brook for patients on Long Island, because we know this disease is extremely hard on the patients and the families. And to add another barrier of having to travel to the city to receive the treatments, which are every two weeks or every four weeks, was for me just not realistic.
And so I spoke with our hospital leadership who are extremely supportive of this work, and we were able to establish the first centers out here, right here at Stony Brook.
12:40 Treatment Criteria
Timothy Brown
You know, we were talking a little bit before the program started, and I told you my mother had Alzheimer’s and eventually died of Alzheimer’s.
And first of all, it’s a horribly cruel disease. I can’t really think of too much worse. But just to get her to appointments and things like that, particularly when we were in the more significant stages of it, was really difficult. And so what a tremendous bonus that is for people to be able to get this kind of treatment here on Long Island.
I just think, again, hats off to you guys are doing great work. What criteria do you use when you’re determining, you know, whether or not an individual might actually really benefit from these treatments? Are you looking for a specific patient? Is there something that you really can point towards?
Jolene Knight, NP
So, of course, they have to either be in the very early advanced, early stages of dementia or mild cognitive impairment.
So we have to do cognitive assessments like the mental state exam and they have to obviously score within the mild stage. We have to look at past medical history to make sure that they would be an okay candidate for this, and make sure there’s no past strokes, they’re not on blood thinners. So we do have to put a lot of work into making sure we’re safely and effectively giving this medication.
13:25 Prevalence in Men v. Women and Genetic Predisposition
Timothy Brown
Do you see more men or women that benefit from this?
Nikhil Palekar, MD
So typically what we’ve seen is that the disease seems to be more prevalent in women. We don’t know exactly why. One theory is because women live longer than men and we know that the rates of Alzheimer’s increase with age. But it’s not just that – there’s more to it than just that.
But yes, typically we do see more women. And I think overall in our infusion program, there are more women than men receiving the treatment.
Timothy Brown
Is there a hereditary component as well?
Nikhil Palekar, MD
There is. So there is a gene called the APOE4 gene, and it’s called the apolipoprotein and it comes in three forms. So there’s E2, E3 and E4.
If you have the E4/E4 variant, that increases your risk of developing Alzheimer’s by ten fold compared to if you don’t have E4/E4. So it’s a risk gene. It doesn’t mean you’ll definitely get Alzheimer’s, but it increases your risk substantially to develop Alzheimer’s. And we test for that E4/E4 genotype in our clinic.
14:30 The Stony Brook Center for Healthy Aging (CHA)
Timothy Brown
You know, we were talking about collaboration just a few months ago, and I think something that we can be really proud of here at Stony Brook is the Center for Healthy Aging, because, again, we’re on Long Island, as you mentioned, the second most quickly, I don’t know I’m not saying this right, but the area that has the second probably highest aging population.
Talk about the Center for Healthy Aging, if you will, and what happens there and why that’s so important.
Nikhil Palekar, MD
So the Center for Healthy Aging is absolutely fantastic. And I’ve been involved in the Center for the Aging right from its inception as one of the committee members looking at how the Center of Aging could help move the needle in terms of research and ultimately finding better treatments for patients who are in the aging process.
And this involves all kinds of aging related disorders beyond Alzheimer’s. So I think it’s been a tremendous effort. And I think the Center for Healthy Aging has already made a huge impact in their ability to fund researchers from Stony Brook who are working on very critical and important basic science research, as well as clinical research on various aging related issues, including dementia and Alzheimer’s.
16:08 Therapies Administered at Stony Brook
Timothy Brown
And again, I think it just shows kind of the power of an institution like this because it goes from the research to care. And that’s obviously what we want to see. And that’s so important. And all of these wonderful advances that are being made to help people as they age and improve quality of life and health. So that’s again, I think, really important.
How many people have benefited from this here at Stony Brook?
Nikhil Palekar, MD
So we have a number, but the number keeps, you know, going up every week. So that’s a good thing, right? So at this moment, I would say on average we have close to about 27 or 28 patients and about 25 of them are on Lecanemab, which was the first medication approved for this treatment.
And we have about three or four on Donanemab, and we add about 1 patient a week or so. So roughly about 4 to 5 patients a month are starting their treatments.
Timothy Brown
You talked a little bit about the process earlier. Is it a fairly quick treatment? It’s an infusion every 2 to 4 weeks, is that right? Does it take a long time?
Nikhil Palekar, MD
Yeah, so it does take a bit of time, so Lecanemab is every two weeks and it takes about an hour to infuse the medication through the IV drip and the entire chair time at the infusion center is about two, two and a half hours.
Donanemab is an infusion that’s given every four weeks. So about once a month roughly, and that takes about an hour and a half total chair time. And currently, these treatments based on the clinical trials, are available for patients for at least 18 months, if not longer.
17:45 Results, Feedback and Outlook
Timothy Brown
Great. Jolene, Dr. Palekar spoke a little bit earlier about, you know, just the reaction from patients, families. What kind of things do you see and how does this change people’s lives?
Jolene Knight, NP
So one of the things that I see that’s really rewarding is hope. There’s hope now. In the past, it was kind of like, this is a terrible disease. There’s no way, nowhere to go. So now that these treatments are coming out, they’re still hopeful and they are seeing some improvements. So they’re really happy.
They’re seeing a little bit less short term memory loss. Their parents are functioning a little bit better. So it’s really, really exciting for the family of the patient for us to treat them.
18:35 Advancements in Therapies for Alzheimer’s Disease
Timothy Brown
And, you know, I think part of the excitement is this, like you said, it does show hope. And so there’s other work that’s being done, too. And it’s a really positive thing.
And I don’t know, Dr. Palekar, you may be able to comment on this, but it seemed like there was a time when, you know, years ago there wasn’t a lot of hope. But there have been advances recently like this.
Nikhil Palekar, MD
Absolutely. So just to go back in history a little bit, the last medication that was approved for this condition was in 2003 and which was Memantine or Namenda.
And we had about 20 years of failures. And roughly from the time we start a phase one clinical trial to the medication being FDA approved, it takes anywhere between 14 to 16 years. So it’s a long process of clinical trials and research that has to take place for a medication to reach a level that the FDA feels comfortable stating that it’s beneficial to the patient.
So this is a lot of hope and excitement. I mean, this is still just the tip of the iceberg, though, because there’s so much interesting stuff coming up down the road. We are looking at new treatments that target amyloid proteins and in the pill form. In fact, we are starting two clinical trials at Stony Brook in June that will be testing two different medications by pill, taking orally that also target the amyloid protein.
There’s also research going on in terms of tau protein. That’s another protein that starts to accumulate in the brain and form tangles. And there are anti tau treatments that are currently being researched.
And then the third really important aspect of this illness is inflammation, neuroinflammation or brain inflammation, which we know often drives a lot of the progression of the disease. And there are also treatments looking at decreasing inflammation. In fact, we just completed a study last year with a new molecule that was focused on targeting inflammation in the brain.
So there’s lots of excitement, lots of hope. This is really amazing for patients and families.
20:40 Clinical Trials
Timothy Brown
You’re making my job pretty easy because you talked about clinical trials and I was just going to ask about clinical trials.
And again, I think that’s one of the strengths of an academic medical center because the actual research is being done here behind the walls of these buildings. And and so patients have, to some degree, the opportunity to access those clinical trials when appropriate.
Nikhil Palekar, MD
Well, absolutely. And again, that was another reason why I wanted to build a clinical trials program.
So our patients and community of Long Island don’t have to travel to the city to participate in these trials because these trials can be pretty cumbersome. I mean, you need to come in once a week sometimes to get assessments done, pretty frequent visits. And so now at Stony Brook, we are the center for the clinical trials right here on Long Island.
21:25 How to be Assessed and Treated at Stony Brook
Timothy Brown
That is just so awesome. I know people are going to be watching this and they’re going to be seeing this and they’ll say, gosh, how can I get my loved one involved with this? Do I need to talk to my doctor and try to get a referral? Do I try to get in a clinical trial?
What do people need to do to be part of this?
Jolene Knight, NP
So they can go on our website, the Center of Excellence of Alzheimer’s Disease, and our numbers are on there and they could just call and ask for an appointment.
We have neurologists referring to us. We have primary care referring to us. So really just going on the website, getting the number, looking at the information and calling, and then they get a call back and we schedule them.
Nikhil Palekar, MD
And I would add to what Jolene said is also that I think it’s important to talk to their primary care doctors if they have experienced any mild memory lapses or any issues that are different than their baseline.
Yes, as we age and as the brain ages, there are certain things that do change. Like, for example, you might not remember the name of a book that you just read or a name of a restaurant when you’re in a conversation with a friend.
But it pops back maybe in a few hours or the next day or late at night. That’s part of normal aging. But if you’re forgetting things on a regular basis and repeating yourself over and over or having difficulty concentrating and that is a change from your normal baseline, you should definitely speak to the primary care doctors.
And now more and more of our primary care physicians are aware of these new treatments and new options for patients, and they would help the patient to get referred to one of the specialty programs like us at Stony Brook.
Timothy Brown
Perfect. So final question. I understand that you’re trying to get infusion therapies for this specifically in the MART. Is that correct?
Nikhil Palekar, MD
We are, the infusions are at the MART, yes.
Timothy Brown
Excellent. And for those of you who don’t know what the MART is, probably most of the people who are watching don’t. That’s the big part of the main hospital here. So, again, convenience. I mean, that’s going to be such a positive thing for people who are living here.
Nikhil Palekar, MD
It really is. And there was a specific reason why we wanted the infusions to be at the MART, because the MART infusion center has all the expertise and they’ve been doing infusions for years. And it’s a beautiful facility. The staff is incredibly amazing. Every single patient who has gone to the mart for these infusions comes back and tells us how amazing the staff is and how well-cared for they are.
So I’m so thrilled that we’re doing it on the MART and they are the experts. They have been infusing all kinds of different drugs, chemotherapy agents, other biologics for years, and they know how to do this, how to take care of patients and how to safely administer these treatments.
24:18 The Future of Treatment for Alzheimer’s Disease
Timothy Brown
Okay, I lied. That wasn’t the last question. So I’m going to ask each of you one more question. What do you see for the future and what do you hope for in the future? Jolene, let’s start with you.
Jolene Knight, NP
So I’m hoping for more research to come out and better treatment options. Maybe you know, something a little bit easier for them, for example, like a pill form of the medication and just more support for the families.
Timothy Brown
Doctor Palekar?
Nikhil Palekar, MD
Yeah, I mean, I think there is so much to look forward to. We have newer treatments that are coming out and hopefully they will translate into better outcomes. So as I had mentioned earlier on, these medications remove the amyloid plaques completely or almost completely.
But they slow the symptoms down or the progression down by about, on average, 27 to 29 percent. But now if we add an anti-tau agent and a medication that decreases inflammation, we might see a slowing of progression maybe 50, 60 percent, which would be amazing.
What does that mean? That means a patient can stay in the early stage for so many years and be able to function and engage with their families or continue to work for so much longer. And that’s the beauty of what we are trying to hope for in the future.
25:28 Closing Remarks
Timothy Brown
This is very inspiring. You guys have been great. I mean, this is really good. And again, you know, for people who have gone through this or have a family member that’s gone through this, it does give hope and it really gives time back to those families, too. So that’s exciting. It’s just wonderful work. The Center for Healthy Aging is a fantastic institution here and it’s really, really exciting to see this.
So thank you so much for being on the program. That’s it for today’s episode of Healthcast. Thanks for tuning in. If you found this episode helpful, and I would think you probably did, share it with a friend and please be sure you subscribe for more health tips that keep you educated and empowered. Until next time, stay informed and stay healthy.
Announcer
Stony Brook Medicine is Long Island’s premier academic medical center. We transform lives through scientific discovery, education and care, and we bring together innovative research, advanced education and extraordinary health care expertise to set the standard for how healthy communities thrive. For more information, visit Stony Brook Medicine or follow us on social media.
*DISCLAIMER: The information provided in this podcast is for educational and informational purposes only and is not intended as a substitute for professional medical advice, diagnosis or treatment. If you think you may have a medical emergency, call your doctor or emergency services immediately.
