New drugs offer hope to Alzheimer's patients, but how accessible are they?

And what about caregivers?

What's the State doing to help them?

That's this week on Nevada Week.

♪♪♪♪♪ -Support for Nevada Week is provided by Senator William H. Hernstadt.

-Welcome to Nevada Week.

I'm Amber Renee Dixon.

Nevada has a rapidly aging population, and as a result, the state has the third fastest growth rate of people living with Alzheimer's.

That's according to the Alzheimer's Association, which estimates that there are 84,000 caregivers in Nevada providing 142 million hours of unpaid care to Alzheimer's patients each year.

What help exists for those caregivers and what treatments are available to slow the brain disorder's progression?

For those answers, Nevada Week visited the Cleveland Clinic Lou Ruvo Center for Brain Health, where we spoke with its Director, Dr. Dylan Wint, as well as Jefferson Kinney, Founding Chair of the Department of Brain Health at UNLV, and Philip Kalsman, Director of the Alzheimer's Association Southern Nevada.

Dr. Wint, I'd like to start with you.

An FDA advisory committee recently voted unanimously to recommend that the FDA approve donanemab.

What does this mean for the Alzheimer's patient or caregiver watching at home?

(Dr. Dylan Wint) It means that the FDA is very likely to give approval to this new drug, which is a disease-modifying drug for Alzheimer disease, to come to the market.

And it really gives us another option.

Right now there's only one disease-modifying drug for Alzheimer disease, lecanemab.

Donanemab is in a similar category.

It's an anti-amyloid antibody, so removes amyloid protein from the brain.

-And real quickly, amyloid protein?

-Amyloid proteins are part of the pathology of Alzheimer disease, meaning they're part of the microscopic process that is toxic to the brain and brain cells.

So having another option of an anti-amyloid antibody just gives us more tools in our chest to be able to fight against Alzheimer disease.

-I want to open this up to everyone.

There is a New York Times article I read in preparation for this interview talking about donanemab.

And it said, quote, Over the last three years, a new class of Alzheimer's drug, the first to treat a root cause of the disease, has set off a roller coaster of hope and disappointment.

Where do you stand on that?

Do you feel like you've been on that roller coaster?

(Jefferson Kinney) So it's been since 2003 that there's been any FDA approvals of treatments.

So adding to the arsenal, adding to what can be used, is tremendous progress, and it's-- these drugs are also a very unique new way of going after the disease.

It's targeting the pathology that actually happens in the disease; whereas, the previous treatments were trying to get at it in a very different way.

So I'd say the last five years especially has been really, really exciting and really promising because the progress is substantially greater than it's been.

-Where does the disappointment fit in, Phil?

(Phil Kalsman) I think for some people it's maybe a drug that they're not eligible for, and their hope is that this drug could be that cure.

And we're not quite there yet.

I think to Dr. Kinney and Dr. Wint's point, as we peer over the horizon, it's bright.

And the investments that have been made in the past are starting to come to fruition.

And more than ever, we're beginning to see some momentum.

And that's encouraging.

Yes, it's true, not everyone is going to benefit from this new drug class, but a lot of people will.

-Let's take lecanemab, for example.

It's been a year since the FDA approved that.

How many people have actually been able to utilize that drug here in Nevada?

-At our facility, about 50 people are on the drug now.

We have other people who are in the pipeline.

There is a process to being deemed eligible for the drug, which includes that the disease has not progressed too far for the drug to not have any benefit for you.

You have to demonstrate the presence of this amyloid protein in the brain.

You can't have any features that might predispose to the leaking of blood vessels, which is the largest or most significant side effect of the drug.

So the process, I think, is one of the disappointments, also, and then the fact that this is mostly for people who are very early on in the process.

That has been a difficulty and a disappointment as well.

-Let's talk about how you prove that you are eligible for this.

-So right now, the demonstration is a PET scan to demonstrate that there is amyloid in the brain and it can be detected.

And it works very effectively, and it's part of the clinical trial process.

And now it's part of the selection process.

-And how accessible is that to the average person?

-It's fairly accessible.

The difficulty is the cost per scan and the rate and number of scans that you can do at any given time.

So one of the things that has emerged as these treatments have now moved into "they can be delivered to patients" is how do we, on a very large scale, identify who is eligible or even identify the disease?

And a clinical interview can do it.

PET scan can do it.

But in both cases, that's difficult to pull off on the scale that is really required.

And this actually represents one of the larger areas of research in this now, which is trying to find more accessible, more rapid ways to detect the disease in blood-based biomarkers.

So from a blood sample, just like when you go to your doctor and they measure your cholesterol, the idea is to identify targets that are indicative of the disease, something that is in your general circulation that can be used to identify Alzheimer's disease and even stage the disease.

-And from what I understand, there has been some pushback to that particular test because let's say you're 45, you get this blood test, you find out that perhaps you may develop Alzheimer's.

But is it for sure that you will, or are you going to go around worrying, Gosh, am I going to have it or not?

-Yeah.

It's a really good question.

So where we are right now is that there are several really promising blood-based targets that are currently being considered for-- you basically have to establish a threshold.

So above a number and below a number is indicative of the disease.

That hasn't been established yet, especially not in the same way that the PET scans have.

But there's a-- there's a sort of alternative side to that, which is, if some of these markers show elevation, you can start talking about risk.

You can start talking about things that can mitigate the risk for the disease.

So it's informative to identify the disease, but it also can be really informative to identify what things could make it less likely, what things could you do to stave it off?

Because there are numerous risk factors for the disease.

So not causal, but if they exist, people are more likely.

And many of them, you can't intervene.

-Phil, Dr. Wint, where do you stand on the blood test?

-We're all for anything that's going to make the diagnosis more accessible for everyone, and we applaud the science that's moving towards that.

-Yeah.

I'm very happy to see the availability, potentially, of blood tests in the near future that increases the ability, for example, to identify who's eligible for treatments.

An amyloid PET scan, as far as I know, there are only two places in this city of 2 1/2 million people that can accomplish those scans.

At our facility, we have to order the tracer that's used for the scan from Phoenix, Arizona.

If they don't get here in time, if there's a delay in traffic, those doses are lost.

So blood tests, of course, are much easier to distribute across a wide number of people, so that will help increase the diversity of people who are being deemed eligible for treatment, as well as enable us to diagnose people who may be at a distance.

-What about insurance costs?

How are they working currently, Phil, in terms of paying for the medication itself, lecanemab, for example?

-Medicare wasn't covering it at all, I don't think at all.

And there was some pushback on that because of the coverage that they're providing for other disease states.

And so they did reverse the decision, and they are now providing coverage for it.

I think where the private commercial insurance is maybe where there's more of a hurdle.

-Yeah.

Commercial insurance is, of course, more variable than Medicare coverage.

My understanding is that Medicare, just the basic Medicare, will cover 80% of the cost of the drug, but the drug is $25,000 a year.

The course of treatment is a year and a half.

So that's still a substantial amount that the patient may be asked to come up with.

And then with the commercial plans, the coverage may be less.

This is excluding the testing that's necessary to even get to the point where the drug is being ordered.

The amyloid PET scan can be from $4,000 to $8,000.

It is now covered by Medicare and by commercial insurers, but, again, the amount of coverage may vary.

As we all know, insurance can say that something is covered, and, yes, it's covered to a certain extent; but we're usually responsible for some proportion of that, and it may be a large amount of money.

-How effective are these two drugs?

How effective have they been shown to be?

I'll start with you.

-For, really, all three of the ones that have come out and read out in terms of their clinical trial, there is a very clear signal of their ability to decrease the amount of amyloid in the brain.

The mechanism of the treatment is a very clever way of engaging immune cells to seek out and find the amyloid protein, right, one of the core features.

And two of these studies showed a remarkable at the highest dose reduction of amyloid in the brain.

The most recent one even showed a clinical benefit.

So it's enormously encouraging to be able to change the trajectory of this protein.

It's worth saying that we're still figuring out exactly what this amyloid protein is doing in the brain.

And Dr. Wint highlighted how it is toxic to neurons; it interferes with how the brain functions.

But there's still a lot we don't know.

So the fact that we can lower the abundance of this toxic protein is remarkable.

The effect it's going to have on patients over short-term, over long-term, we have a lot to learn.

But it looks really promising.

-I was just going to say that on average in the lecanemab studies, participants in those studies went to an amyloid level that would have been negative on the amyloid scan.

So if they had walked into someone's office after getting the treatment and were given an amyloid PET scan, they would be told that they don't have any evidence of amyloid.

It's important, though, to remember amyloid is not the only contributor here.

Some studies have shown that amyloid accounts for about 30% to 35% of the overall cognitive decline and that other factors, lifestyle factors, the other main protein in Alzheimer disease, called tau, that they account for the bigger proportion.

But amyloid is still a very big component.

And clinically in these studies, what we saw was about a 30% slowing of decline.

So this does not stop decline, it does not reverse the problem, it doesn't even cut down the slowing-- or it doesn't even cut down decline by half.

But it is a bigger effect than we've seen with prior drugs, and it's hoped that, because it's a disease-modifying effect, that that difference between someone who's on the drug and someone who isn't will grow larger over time.

-I've been trying to look for my notes to find out.

I think there was a month, a time frame put on it, on how long it slows, like maybe a six months' slowing down of the progression.

Am I-- -Yeah.

Over an 18-month period, we would be looking at a little bit under six months of slowing.

So it's as if you turned back the clock six months at the end of that study.

-Doesn't seem like a lot of time.

-But it brings one more trip to a family reunion.

It's one more opportunity to see the grandkids.

It is quality of life that we're extending, and that's measured by the patient and the patient's family.

I think that's what's important to keep in mind.

It, to Dr. Wint's point, it is not going to stop it.

It's going to mitigate and slow down the progression of it, and that is buying people more memories and more time.

-And we don't know at this point what happens after those 18 months, but it's important to remember that individuals for whom this drug is effective are people who are in the earliest stages of disease.

When we're talking about a disease that's 10 to 15 years in duration, if that 30% benefit holds, then by the time you get out to nine years, you're talking about a three-year turning back of the clock.

12 years, you're talking about four years, and so on.

Now, we don't know whether that 30% will hold, whether people will have to be retreated at some point.

But we should remember that the studies are kind of like a 100-yard dash, and the disease itself is more like a marathon.

-This is the first time that we've ever been able to directly engage the pathology of the disease.

So the amyloid part of the story of Alzheimer's disease is the early phase of it.

This also defines why only some patients are eligible for it.

And as the amyloid builds, you also get into the other pathology.

So we are just at the start of seeing how much the reduction of amyloid beta, the protein, how much the reduction of these drugs changes it over a three-year period, over a five-year period.

Are we going to redose again a few years down the road?

But the other thing this really opens up an opportunity, and this sometimes gets lost in the conversation, there are scores of drugs in clinical trials right now behind these that engage this target and other targets that can be used in combination therapy.

So the fact that we finally have the ability to hit at one of them means now there's opportunities to hit at other targets, and it's just going to progress from here.

-I do want you to repeat the point you made about who these medications can benefit, because there is-- you define how large it is of a population that will not be able to take this simply because of how far they've progressed.

-So the bulk of people with Alzheimer disease that is clinically detectable will not benefit from these drugs.

It's not that we don't want to give the drugs, it's that studies have shown that people who are at moderate or severe stages of disease do not benefit from the drugs.

So moderate, we would roughly say, someone who is having any kind of trouble taking care of their personal space, needing reminders to bathe, help with grooming, assistance with feeding themselves, and so forth.

So we're really looking at people who either are still performing their routine activities of daily living despite the fact that they have a memory problem--so that's mild cognitive impairment--and then people with mild dementia who may be having some trouble with more advanced activities of daily living, paying bills, navigating in the car, the sorts of things that maybe you would need to go-- need to know to go to college, but that you don't really need to know just to sort of exist and take care of yourself.

And then people who are on blood thinners, who need to take blood thinners for other conditions, cannot take these drugs.

People who have severe cerebral vascular disease, so that's damage to the blood vessels in the brain that blocks off blood flow, the second most common cause of cognitive decline and also present in about a third of people with Alzheimer disease.

If you have severe cerebrovascular disease, these drugs are not for you either.

So there is truly a limited population.

But I hope people won't think of that as that there's no hope for them, right?

We've-- this is just an additional tool, and this additional tool is beneficial to some of the people out there, not for all of them.

-For the segment of the population that have advanced past that mild state, what do they need?

What are their needs?

-Quality, comfort, and care.

You know, we do our best at the Alzheimer's Association to help people navigate where they are.

If you've met someone with Alzheimer's, you've met one person with Alzheimer's, because everybody's story is a little bit different.

So they're coming to their healthcare provider and taking care of the pathology of the disease as it progresses, but their caregiver is also in need of support.

And so we help with understanding, you know, the progression of the disease, understanding behavioral modifications that are going to be happening.

We have classes to help people make sure that their finances and their legal estates are in order and all of these things in addition to caregiver support.

We have support groups that help with caregiver stress, recognizing when they need a break.

It's a huge undertaking.

Dr. Wint was saying this is 10, 12, 15 years' worth of work.

And it impacts-- 60% of the caregivers are still working, and so it's a huge undertaking when you're working all day and then coming home and providing caregiver services until 10 or 11 at night.

It's a lot.

-And how is it impacting the economy?

-We know, and when we think about our economy here in Southern Nevada, the thousands of people that work up and down Las Vegas Boulevard, we know that there are a certain percent of people who are passing up promotions because they can't commit to it.

We know there are people who are being disciplined at work because they're calling in with excessive absenteeism because of caregiver obligations.

They're coming in late because of caregiver obligations or having to get someone to an appointment.

It does impact our businesses here more than people think.

And we're working with-- we have a program we're starting to roll out now through Worksite Wellness.

So we can go into some of the larger employee groups and the smaller ones as well, but help them help their employees, help them recognize the folks that need some assistance and what's really going on at home.

But also to Dr. Wint's point earlier, you know, this is not necessarily an older person's disease.

There are people who are very active in their late 40s and 50s who are starting to show signs of mild cognitive impairment and don't necessarily know what's going on and don't necessarily want to talk about it, but it begins to impact their work, right?

And so getting people more comfortable talking about the 10 warning signs, as we call them, what to look for, what might be a need or that, that red flag, maybe it's good idea we go talk to our healthcare provider.

-And the warning signs, are they different than the risk factors?

-There is genetic risk for a gene called APOE, and everyone has two alleles of this.

And if you have one of the, it's called the e4 allele, risk goes up about four times.

And if you have two of the e4 alleles, it goes up about 12 times.

-Can you find out if you have this?

-You can.

-Through a blood test?

-Through a blood test.

In fact-- -Is this something I could go order?

-Yeah.

You could ask your doctor to do it.

Other risk factors, and we have research projects, we and others in a lot of different locations are addressing this in many ways.

So diabetes, type 2 diabetes confers increased risk; cardiovascular issues; there's risks associated with how active you are.

So a lot of the risks can be mitigated, though, through things that people hear all the time, which is good diet, good exercise, things like this.

These are things-- -Social activities.

-Social activities.

-Staying active.

-Will you tell us those signs that people need to be watching out for?

-We get phone calls of people that literally will say, My dad keeps losing his car keys, and last night we found them in the freezer.

That's when we know there's kind of a cognitive disconnect.

That's-- we all lose our car keys.

The other one that's-- that we hear upon occasion is, you know, basic math and finance issues.

Somebody who couldn't add the tip up at dinner, who's, you know, that's so unlike them.

Withdrawal socially is another big one.

Just very familiar tasks that someone was doing and is having trouble now doing.

Getting lost, spatial issues, things like that, that you know something's up.

And again, it could be a UTI.

It could be polypharma.

Maybe they're on a new medication that's causing the cognitive impairment.

Yet again, another reason to go talk to your healthcare provider.

Let's find out.

Let's find out, because it is worth looking into, obviously, and something that maybe can be done earlier rather than later.

-I would add rapid and complete forgetting.

So it appears that the person just doesn't seem to have things stick in their memory.

So what might happen is they might repeat questions that have been answered.

They may repeat stories that they've told within minutes sometimes or within hours, but you get the sense that information is leaving their brain and there's no evidence that they've heard the information before, even though we know it happened.

Forgetting that they've been to a restaurant, Oh, this is a new place, and they were there a month ago.

Forgetting that a conversation occurred, We talked about this.

Nope, we didn't talk about it.

And there's no ringing up the bell, so to speak, when they are given some context and some cues.

It's important to get any changes in cognition checked out, because they're not all going to be Alzheimer disease.

As Mr. Kalsman said, the goal is not really to identify someone as being ill.

The goal is to help someone feel and function as well as possible for as long as possible.

And that may include treating something like Alzheimer disease, but it may also include addressing other problems--vitamin and hormone deficiencies, sleep disturbances are very common--that are causing the brain to operate inefficiently but, in some cases, are fixable.

-Last question, because we're running out of time.

And this is for you, Phil.

What currently exists to help caregivers in the state of Nevada?

What would you like to see happen to services?

-I think one of the-- we have a helpline.

And I hate referring to a helpline, but it's one of those 24/7 opportunities that people can call if they need referrals or assistance finding something or just need to talk to someone.

We have master's level clinician who answer the phone.

It's one of those things, again, at three in the morning, if you're at your wits end and you're not understanding what's going on with your loved one, you can call and get help.

In addition to that, we have local support groups.

We have education opportunities, virtual and online-- or virtual and in person.

And respite, we have through the state of Nevada, we are, we're able to provide respite for families who need to pay for adult day or an overnight service for their loved one because they have something they need to go to.

Maybe they can't take their loved one with them.

-And you said, I think, about $1,000?

-It's $1,000 a year, uh-huh, and it is a little bit that just helps someone.

And it's not emergency aid.

We can't turn it around overnight, but we have a program that people can apply to.

There's no-- you don't have to, you know, be under the poverty level or anything like that.

There's no qualification for it.

It is just a little bit to help people be better caregivers when they need the help the most.

-What do you think you have the best chance of getting through state legislation next session to help caregivers?

-I'm hoping that some legislation that, that we're working, that we're proposing to help caregivers and to help set up more of a navigation program that would just help us as a state, help all of us, help our family members navigate this all a little bit better.

-Gentlemen, thank you so much for your time.

-Thank you.

-And thank you for watching.

For any of the resources discussed, go to our website, vegaspbs.org/nevadaweek.

And I'll see you next week on Nevada Week.

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