Transcription:

Scott Webb: Welcome to Check-up Chat with Evergreenhealth. I'm Scott Webb. And joining me today to discuss a promising drug treatment study for patients with Parkinson's disease dementia is Dr. Daniel Burdick. He's a physician at Evergreenhealth Booth Gardner Parkinson's Care Center and lead investigator for this Parkinson's Disease Dementia Trial.

Doctor, it's so great to have your time today. As I mentioned in my intro, we're talking about Parkinson's disease with dementia in this randomized placebo controlled double blind study of ATH-1017, that drug treatment in subjects with Parkinson's disease dementia. Let's start here. What is the objective of the study?

Dr. Daniel Burdick: As you say, the study is looking at a new drug for Parkinson's disease dementia, that's ATH-1017. The study specifically is looking to assess the safety and tolerability, so to make sure that it's safe and well-tolerated in patients with Parkinson's disease and then, secondly, to find out if it improves cognition in those patients. By cognition, we mean ability to think, find words, remember, recall things, skills like that.

Scott Webb: Well, it sounds pretty amazing. I'm sure optimism is high, right? And especially within the Parkinson's disease community. So maybe you can talk about why this trial is so important. What makes it so special?

Dr. Daniel Burdick: Yeah, absolutely. And I agree, I think, optimism is high for it. I think two words, disease progression is really what it comes down to. We have a number of treatments for the motor symptoms in Parkinson's disease. That is the difficulty with movement and just walking and dexterity, things like that. And it's important to take those medications to help with the symptoms and the physical disability, but, A, we don't have great treatments for the cognitive symptoms in Parkinson's like I described and, B, we don't have great treatments to help slow down the progression of the disease. So that's a question that I get a lot of times in my clinic visits with patients. You know, what can I do to help slow down my rate of progression? How can my future be as good as possible?

And while there are things, lifestyle modifications, that we can make to help with disease progression, things like making sure you're exercising regularly, socializing, you know, engaging socially with people around you, , learning new things, new activities, having new experiences, those things are helpful for slowing down the rate of progression. But in terms of real medical treatments, we really don't have anything right now that helps slow down the rate of progression. And in this case, in the case of ATH-1017, the whole point of a study is to find out if it will have the intended effect. But the original animal studies with this drug did show that it could improve the health and survival of brain cells, neurons. It helped grow new connections, synapses between brain cells. And so that can help with the symptoms and disease progression, and it reduced inflammation in the brain around these cells. Now, those were in animal models, like I said, and the whole point of a clinical trial in people is to find out if those effects are seen in humans, but that's the reason for the optimism and why it could be so important to the Parkinson's community.

Scott Webb: Yeah. I mean, one of the things I love about doing these is just hearing the optimism, the encouragement. And, you know, there's just things as human beings. I don't need to tell you, but there's just things that, it would be great if we didn't get, right? It would be great if we didn't get cancer or diseases like Parkinson's. But unfortunately, because we are human beings and we do get these things, and as you say, there are things we can do behavior lifestyle-wise, but what we all really want, if we get these things that we couldn't prevent in the first place is to slow it down, to sort of turn back the clock a little bit. My wife has a retinal disease called retinitis pigmentosa, and all I would really want for her is to be able to turn back the clock a little bit. And I'm sure in a way that that's really what the Parkinson's disease community would want, right? Like, "I've got this thing. I don't want it, but can you slow it down?" Can you turn back the clock, doc?

Dr. Daniel Burdick: Right. I mean, that's exactly the question. As I said, we can't slow down the rate of progression other than through these important, but limited behavioral lifestyle changes. The medications that we have, they do help the symptoms. It's important to treat the symptoms. The way I describe it a lot of times is like if you're on the Parkinson's disease mountain coming down the hill, what our medications do right now is kind of get you back up higher on the hill, where the symptoms are less, you have a better view. Things just are a little bit easier, less disability, but what we'd really like, and what we're missing right now is the ability to change the slope of the mountain, right? Make it so it doesn't go downhill so fast. And that's what we're looking for.

Scott Webb: Absolutely. And as I said, I did some research and wanted to try to understand who's eligible to participate. Is there an age range? Is there a minimum, maximum age, you know, that sort of thing?

Dr. Daniel Burdick: So number one, we're looking for patients who have Parkinson's disease and have had some impact on their cognition, that is, you know, ability to recall ability to find words, ability to problem-solve, understand explanations. And they should have some difficulty with those symptoms to at least a degree where it's more difficult to engage in certain activities during the course of a typical day.

Other than that, there are a number of specific eligibility criteria. But with that screening, we'd be happy to talk to people and go through the specific eligibility criteria. You mentioned age, and there is an age range. it's from the age of 40 to 85. So it's a pretty broad range really. But, like I say, with those initial screening variables, if you meet those, we'd be happy to review the other eligibility criteria in detail.

Scott Webb: Yeah. And you can see if somebody had Parkinson's why it's certainly worth reaching out, right? Let's talk about this. I guess I'm wondering what does participation really mean? What does that entail?

Dr. Daniel Burdick: I try to think of clinical trial participation as a donation of time. That's really the biggest thing for patients to think about. To advance Parkinson's disease research to find these new treatments, the Parkinson's community, and by community, I mean, researchers, clinicians, patients, family member, so the whole community wants to advance treatment of Parkinson's disease, and to do that, really we need the basics of life, right? Which is time and money. And so in this case, we're asking for time. Participating in clinical trial does involve more time than you would typically give to regular clinic visits. In this case, the study involves nine to ten visits over the course of about six to eight months. So not highly frequent, but certainly more than you would normally see your doctor. And each visit is also pretty involved. It takes potentially several hours. You know, some visits are a couple of hours. Some of the visits may extend to most of the whole day. So it really does require a time commitment.

In the visits, just to give people a sense of what they might be doing while they're here, first, there are a number of assessments to assess safety of the drug. And these are things you'd probably have done at regular doctor visits, so a physical exam, lab work, EKG, things along those lines. And then there's also a number of assessments to evaluate efficacy, the effect of the medication. And that really just comes down to, again, other portions of the physical exam, going through questionnaires, which could be either interview style with me or one of my research staff members, or maybe just filling out paperwork or online form individually. And then in this study, we're also doing EEGs to assess the effect of the medication on kind of brainwaves that can correlate with those cognitive abilities.

So that's what would be involved in the visits here. It does also involve, of course, administering the medication. And in this case, the medication is administered just like insulin is in diabetes. That is via an injection with a very small needle that just slips right under the skin. And that would be given at home, either self-administered by the participant or by the spouse or other family member, caregiver. And so that would be given every day. And some people have been a little bit nervous about that as they've come into this study, but with a little training, a little practice, everybody who's gone through so far really hasn't had too much trouble with it. They've gotten used to it and just been able to give that shot once a day and move on with the rest of their day.

Scott Webb: What I love about these types of trials, whether it was the COVID or now Parkinson's, this ATH-1017 trial is that folks, of course, want to help themselves, right? Of course, that's understood. But in giving of your time, as you say, you're helping yourself hopefully, because there is optimism, but you're also helping everybody else in the Parkinson's community ultimately if this is successful. So I really love hearing that. It's really encouraging, brought a big smile to my face. And I wish I could talk to you all afternoon and just keep picking your brain. I'm sure listeners would love that as well. But doctor, as we wrap up here, how can someone learn more about this trial?

Dr. Daniel Burdick: Yeah, absolutely. And first, I share that enthusiasm. I mean, it's why I do this part of my job. It really gives me a sense we're making progress and we're getting towards a goal of having better treatments for Parkinson's disease.

For anybody who wants to participate or just find out more about it, they can contact Evergreenhealth Research Department either by phone, that's (425) 899-5385 or of course, they can go online. We have a website specifically for this study, which is at www.evergreenhealth.com/pdd, that's Parkinson's disease dementia, so pdd-clinical-trial, or they can also go onto the main research webpage for the research department here. And that's evergreenhealth.com/research.

Scott Webb: Well, doctor, I really appreciate your time. I love learning from experts. And I'm as optimistic as you are. So thank you so much for your time. You stay well.

Dr. Daniel Burdick: Well, absolutely. I appreciate your time and helping us getting the word out. Thank you.

Scott Webb: And for more information, contact Evergreenhealth Research Services at (425) 899-5385 or visit evergreenhealth.com/pdd-clinical-trial. Please remember to subscribe, rate and review this podcast and all the other Evergreenhealth podcasts. For more health tips and updates, follow us on your social channels.