This segment focuses on misconceptions of clinical trials and who qualifies for the Lewy body dementia clinical trial. Dr. Daniel Burdick, a physician’s investigator at Evergreen Hospital Medical Center in Kirkland, Washington, covers these topics with Suzanne Newman.
Regarding misconceptions, Dr. Burdick says he’s often asked about placebos. He explains that people have an expectation that the the reason to go into a clinical trial is because it will benefit them. And of course they hope it will, but they don’t know that it will for sure. When people hear there’s a chance of getting a placebo, they think maybe it’s not worth participating in the trial. That’s a misconception, because the only way we can know if a treatment is safe and effective is by comparing a group of patients who take it with a group of patients who don’t. Even if a person participates in a trial and gets the placebo for the double blind period, they are still contributing to something that will make their own future better.
Another misconception is their stage of progression. Some people feel they’d go into a clinical trial only if there’s no other chance, no other hope. That might have been the case in oncology trials in some other era, but it’s not the case in neurology trials, and not for the shape trial and other trials in Parkinson’s dementia and Dementia with Lewy Bodies. They’re looking for people who meet the eligibility requirements, but who have maybe not advanced that far in the disease, at a moderate stage of the disease. Some trials for Parkinson’s are looking for people in early stages of the disease. Regardless of your stage in a disease, you can find a clinical trial to participate in.
Some people may wonder if a drug in a drug trial is safe. By the time a drug is being tested in patients with the target disease, which is called a phase-2 trial, it has already gone through initial safety trials with animals and a phase 1 trial in healthy people who have volunteered to make sure the drug is safe.
Who is eligible to participate in the shape trial? Candidates are 40-85 years old and have been diagnosed with Parkinson’s disease dementia or Dementia with Lewy Bodies. There are other criteria. There’s no cost to participate, and actually you get a small stipend for each visit.
Many patients being assessed at the Evergreen site have a primary care doctor outside of the Evergreen system, and they communicate with the primary care physician, ask for medical records as part of the screening process, and if any medical concerns come up, they communicate very closely with the primary care doctor for followup.
Participating in a clinical trial is the best quality of care anybody can have, because of the intense attention, you’re much more involved, monitored more closely, you’re far more equipped to recognize progression of the illness than an average person would notice.
The shape trial studies a specific treatment for Lewy body dementia. It’s being studied in Florida, Georgia, Michigan, Oregon, Pennsylvania and Washington, To learn more and sign up for this trial, go to https://shapetrial.com/. If you’re in the Seattle area, you can also sign up at Evergreen Hospital Medical Center in Kirkland. Courtesy of Athira Pharma.
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*The following is the output of transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors.
The following podcast is provided by a Thera Farma and answers for elders radio, and welcome back everyone to the answers for elders radio network, also on your favorite podcast channel. And we are here again talking about Louis Body Dementia Clinical Trials, and certainly I am learning so much about this process and I hope you listeners that are still with us are doing so also. And we’re privileged to have Dr Daniel Burnock burdock from the Evergreen Hospital Medical Center in Kirkland, Washington. and Dr Burdick, thank you for sharing your knowledge with us this hour and you know I’m learning a lot about this. This is amazing. Thank you. Yeah, now, thank you for having me in, thanks for giving me the opportunity to share these things. Well, it’s important work, for sure, and so, Dr Burdock, we’ve been talking about this amazing clinical trial and you know I’m going to I know we’re closing up and we always want to close on a positive note, but I know that there’s going to be probably people that have listened to all this and they’re going like, you know, this might be too good to be true. I’m not sure all of those things so first, if want, I want to just go through an address the misconceptions people have sometimes to clinical trials. Would you kind of share some of the things people ask you about those things? Absolutely. One topic that I get asked a lot about, and I’ve mentioned this earlier, but one topic is the question of the Placebo. HMM. I think people have, if it’s a misconception, for say, but they have an expectation that the reason to go into a clinical trial is because it will benefit them. And of course we hope it will. We hope it will, but we don’t know that for sure. Sure, and so when they hear that there’s a chance for having a placebo, they say, well, then it’s not really worth it. And and that’s the misconception, because it definitely is worth it. As I mentioned earlier, the only way we can really know if a treatment is safe and effective is by comparing a group of patients to take it a group of patients who’s don’t. And really what we’re all wanting is to drive better treatments for the future. Sure, so even if a person participates in a trial gets the placebo for that double blind period, they’re still contributing to something that’s going to make their own future better. So for that six months you may or may not get something that’s beneficial, but it helps for the future after those six months. Sure that’s it really. I can’t desize enough the importance of that placebo arm. Yeah, so that’s the one misconception. I think another misconception might be stage of disease. So some people feel like they’re that you’d go into a clinical trial only if there’s like no other chance, no other hope. Right, yes, and you know where that might have been the case in oncology trials some other some other era. That’s definitely not the case with neurology trials. Really not the case for the shape trial or for other trials in Mental Dowi bodies or Parkinson’s disease. We’re really looking for patients to meet the eligibility criteria but have maybe not completely advanced disease or, you know, a moderate stage of disease. There are other trials in Parkinson’s, for instance, that are looking for very early Parkinson’s patients to try to make a different in the course of the disease. So regardless of your stage of disease, you can find a clinical trial to participate in. Right. So, yeah, well, and I think the other things. What? What’s that? Go ahead, but those are those are the two misconceptions I I would call out. Yeah, I think the other one just basically is, you know, I’m beyond help, another words feeling this depression side of it, like it’s not worth it or it’s not going to make my life but any better anyway, or that feeling of, you know, it’s just it’s not worth the time kind of thing. And I think that’s the thing where a lot of people think, oh, that’s nice, but kind of a thing. And I and and then the other side that I always hear is is I don’t want to be a Guinea pig, quote unquote. What I really want to emphasize is that any drug that you’re going to give somebody is safe, is it not? Well, yeah, so that’s actually a couple of really important points there. So number one, by the time we’re testing a drug in patients with the target disease like park it has already gone through least, of course, animal studies and then a phase one trial, which is usually conducted in healthy individuals. And so those are the page those are the individuals, healthy patients healthy people who who have volunteered to just try this brand new drug and make sure that it safe. By the time we’re getting to this shape trial, which is a phase to study, it’s already gone through the the initial safety trials I mentioned. Of course we’re monitoring individual safety during the course of the trial very carefully. That’s that’s really important. But we do have a experience with a number of other people who have already used this drug. Hm. So I think that’s important. Yeah, I think that’s a really important point to make. Thank you. Well, you know, and I think that’s the important thing. And so, you know, I want everyone to know that you are worth it, and I also want to know, like, who is your ideal person if you were going to find somebody up for a trial? You know what, who’s the kind of person that fits for this trial? Yeah, absolutely. So for the shape trial we’re looking for people who are between the ages of forty and eighty five. So it’s pretty pretty broad range for yeah, ideally well, high definition diagnosed with Parkinson’s disease, dementia or dementia with Louis bodies. And, to be honest, we’re willing to do an assessment to see if there’s dementia. So if you’ve noticed that you’ve been diagnosed with parkinsons disease and and have noticed some of these cognitive symptoms we were talking about earlier, couple remembering, couple understanding trouble with planning or executing sequential steps, we can have you come in and do an assessment and see if it’s something that would be to be interesting for you and you know, at every least maybe not come in, I guess, right away, but but our research coordinators could talk to you on the phone and get a little bit more history and go through the other the other eligibility criteria that it’s qualified. Yeah, and as far is is there a cost to participate in this, suddy, oh no, thanks for that question. Absolutely not. There’s there’s no no cost for any of the visits. Everything within the clinical trial itself is paid for. In fact, there’s a small stipend for each visit. So He’s getting a small yes, so they actually get their gas paid for, the parking costs or anything like that. Is that correct? Yeah, that’s it’s free parking here to I’ll throw that out. But yes, covering the gas costs or something like that. Yeah, yeah, yeah, and and you obviously you say people come from you know, they drive a little white ways away. It probably is a good idea to live pretty much in the you know, greater puget sound area, correct, just to make sure that you’ve got where your your net is basically. Well, yeah, certainly for our study site, I mean we have patients coming from far north has actually as far north is Blane, come from Bellingham, some from other side of the cascades. So but certainly within maybe a two to three hour drive. Okay, most common. Sure, sure, yeah, but I will say to a should point out that, as you mentioned earlier, the shape trial does have sites elsewhere in the country and so you’re interested listening to this somewhere else, by all means go to the shape trialcom website and find a site that you could use to participate. Absolutely and that’s you know, and for those of the you that are listening to us on podcasts or on Youtube, certainly check the website and see if it is in your area. And and you know, I just want to talk briefly, just to close out, is talking about quality of care. I think one of the things that we touched on it earlier, but I really want to bring it home to the fact of participating in a clinical trial, in my estimation, is probably the best quality of care anybody can have because of the extra attention. You’re much more involved in you know all that, you’re monitored more closely. You’re certainly equipped to recognize progression of an illness that they may not you know, that may not be noticed by an average individual and things like that. Obviously we want to make sure that every single thing, that the people that are involved in the clinical trials have the highest standard of care and certainly working with Evergreen Hospital, is the case now in the last question that I want to ask is, what if somebody has a different primary care doctor, let’s say, and you know that’s outside of Evergreen Hospital? What how does that affect that relationship? Do you have interaction with their primary care physician or that person that they’re working with? How does that work? Well, sure, and actually we have a many patients who are not within the evergreen health system. So we’d write them patients from throughout and yes, we will communicate with primary care doctors, though we do ask for medical records from them, in fact, as part of the screening process and and actually when there are any medical concerns that come up through our safety valuation, we communicate very closely with the primary care doctors off range for follow up if some abnormal lab comes up, for instance. But yeah, I mean, just to your point, I think the attention that’s paid during a front of a trial is is is intense. We’re really communicating closely with these patients and and really, frankly, building a bond. I think everybody who participates in a clinical trial feels much more of a connection. Yeah, to the people. Hey, I I guess saw my doctor every you know, couple months, every six weeks. I you know, that’d be I’d be pretty amazing. They know a lot more about me than they do every like my once a year visit. Right, that’s absolutely true. That is correct. So so, Dr How do we reach you and how do we get involved in the trial? Why don’t you give us the website again? Website again, so it’s www dot shape trialcom and for the evergreen health website at Evergreen healthcom flash research. Or you can call four to five eight ninety nine, five, three eight five. I am so honored that you were with us this hour, Dr Burdick. It’s been a just a pleasure and an honor to visit with you and I hope that those of you that are listening out there pay attention to your loved one if they have Parkinson’s disease or anything associated with that. If you have questions, please pick up the phone and call. And certainly I want to thank extra special thanks to a their a farmer, who brings us these amazing conversations from the top doctors across the country and the world, and we are just really honored that you spent the time in your busy schedule, Sir, to be with us today. So thank you very much the pleasure. Thank you to them and to each and every one of you. Please know that you’re loved and you have a family that loves you. So I hope each and every one of you out there remembers one thing as I sign off. Be Good to each other. Take care. Till next week. The preceding podcast was provided by a Thera farmer and answers for elders radio. For more information about the Alzheimer’s clinical trial, go to a thera clinical trialscom
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Founder and CEO of Answers for Elders, Inc., Suzanne Newman proclaims often, “Caring for my mom was the hardest thing I ever have done, but it was also my greatest privilege.” Following a career of over 25 years in sales, media, and marketing management, Suzanne Newman found herself on a 6-year journey caring for her mother. Her trials and tribulations as a family caregiver inspired an impassioned life mission outside of the corporate world to revolutionize the journey that so many other American families also find themselves on. In 2009, she became the founder and CEO of Answers for Elders, Inc., subsequently hosting hundreds of radio segments and podcasts, as well as authoring her first book. Suzanne and Answers for Elders, Inc. have spent 14 years, and counting, committed to helping families and seniors along their caregiving journeys by providing education, resources, and support. Each week on the Answers for Elders podcast, Suzanne is joined by vetted professional experts in over 65 categories including Health & Wellness, Life Changes, Living Options, Money, Law, and more. Suzanne lives in Edmonds, Washington with her husband, Keith, and their two doodle dogs, Whidbey and Skagit.
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