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Clinical trial for Lewy body dementia, part 3


This segment focuses on what doctors test in the Lewy body dementia clinical trial, as well as the importance of the study participant’s care partner. Dr. Daniel Burdick, a physician’s investigator at Evergreen Hospital Medical Center in Kirkland, Washington, walks Suzanne Newman through these aspects of the clinical trial.

In the shape trial, doctors are looking at elements of safety and efficacy. Safety issues include studying bloodwork, physical exams, and checking things like changes in mood. The efficacy of the medication is studied by assessing the participant’s cognition: the person’s ability to remember, recall, fluidly use words, retain their focus and comprehension, and plan and follow events. They’ll be asked to recall words and draw figures, and these are compared from the beginning to the end of the trial. Doctors also measure brain waves with EEG to get more objective data than they can from asking questions.


By the nature of the disease, many participants in a dementia drug trial are at a point where they’re not able to assess some of their own symptoms. One of the more frustrating aspects of these diseases is that the disease itself affects the person’s ability to reflect and recognize their symptoms and limitations. One person says they can do this just fine, while it’s obvious to someone else that they really can’t. It drives the need to develop these treatments, to hopefully slow down the progression and avoid that stage.

It is a requirement of the trial — and also important for a patient’s care and safety — that they have a care partner who participates with them in the trial, someone who is a regular participant in the patient’s care. It could be a spouse, or another family member, a private caregiver, as long as it’s someone who’s with them most of the time and can observe their changes over time. And they come with them to the medical center visits.

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 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 podcast is provided by a Themera Farma and answers for elders radio and welcome back everyone to answer for elders radio network. And we are here courtesy of a theory of Farma and we are here with Dr Daniel Burdock from the Evergreen Hospital Medical Center. and Dr Burdock and I have been talking about Louis Body Dementia and specifically the shape trial that is going on it Evergreen Medical Center right now. And I apologize in our last segment we did not get the website. So, Dr Burdock, I would love for you to share. How do people reach your trial? You are so two websites to go to. WWW shape trial as hpe as sorry, shape trialcom, or the Evergreen Health website is www dot evergreen healthcom. Flash Research. Fabulous, fabulous and certainly we know, you know, we’re so proud to have evergreen hospital because they really do an amazing the whole medical center of all the things that they do and just for the community overall, and this is certainly one that we’re really excited to learn about. And so you know, we talked in our last segment, Dr Burdick, about you know what is it mean to be a part of a trial? And I think one of the things that we talked a little bit about with Louie to body dementia is up until now there has it been a great prognosis. Obviously there’s you know, once that happens it’s just at decline, whether it’s slow, whether it’s medium. You know, everybody’s different. It seems like I know a traditional dementias and all Alzheimer’s. The younger you are tends to be that you get diagnosed, the faster progresses, which is kind of sad. And but is that the same, by the way, for Louis Body Dementia? Actually, with the Louis Boddy did he older age of on said usually is a faster progression. Okay, so that’s different or yeah, yeah, okay, well then that’s good to know. See, like I said, I know about it much on it is ahead of a pin right. So so obviously, if you’re involved in a trial and you’re learning and you know you’re getting involved in you have this wonderful advocate that you work with and a physician and you you know you’re doing this trial over the months as as a physician that is conducting the study. I guess. What are the what we call the endpoints or what are you looking for to, you know, the progression of the trial that knows that you’re finding success? I guess that’s my question. Sure. Yeah, so I talk about this generally a little bit earlier. will go into more detail now. So it’s twofold safety and efficacy, as I mentioned earlier. The safety side, that’s kind of what we discussed earlier, I guess. But the safety issues are, you know, checking labs, physical exam changes, Ekg, a couple of scales around changes in mood, etc. So those are the basic safety assessments that we can do. The efficacy to find out if it’s effective or not, is a little bit more and more detailed. The the main assessments is around cognition. So we talk about cognition and Dimensional Louie bodies and Parkinson’s disease dementia. We’re thinking about person’s ability to remember, to recall, to speak fluently, to come up with the words they want. You maintain focus, attention, to comprehend explanations, the plan and and follow sequence of events kind of things. So all these higher order cognitive process what we’re primarily interested in and we assess those with both with questions around symptoms and both what we can assess and what the caregiver can observe. And then also we ask for we ask the participants to basically perform very specific cognitive tasks. So we’ll ask them to remember words and how many can they recall after a certain amount of time, or to draw figures and how well can they draw complicated figures? So these sorts of cognitive games, I like to think of them. Right. So we look at how well they can do those tasks at the beginning and then how well they can do those tasks at the end, and the rating system that’s a way to score those assessments and we can can kind of compare beginning to end. Then I mentioned earlier to one of the other ways that we’re assessing effectiveness in this trial is by measuring the brainways using an EG which is that I think is a very interesting approach. It’s a little bit newer way of doing it and can give us more more objective data rather than just asking questions, I guess, more objective data about the brains response to the medication. Yeah, and I know if if somebody has Parkinson’s disease, one of the things is the just the ability to move our just to we you know, general like take a step a lot of times. You know, I’ve talked to other Parkinson’s experts and they talked about the music is a big motivator to help somebody get into a rhythm of us, something like that, you know, in the treatment of Parkinson’s. So I’m wondering how that affects somebody that’s has those kind of symptoms moving into being diagnosed with Louis Body dimension. Is there a affiliation with movement at that point that changes? Well, yeah, so. Well, so, if it’s Parkinson’s disease, dementia, those sorts of problems have been present for usually many years, at least a year right with dimension, with Louis bodies. It’s possible that you may have dementia without those motor symptoms, but they usually developed very quickly afterwards it. And so, like I say, it’s difficulty with mobility and dexterity, maybe with tremor, though the tremors less common and mentional Louie bodies and it is with Parkinson’s. HMM. So yeah, those those sorts of symptoms are definitely present and we do assess those as part of the trial. Well, so we’re we’re again asking about symptoms of mobility difficulty, to there any difficulty, and then we also have a rating system for evaluating those movements on the physical exam portion. So right, that is a part of the effectiveness tents. Right, and so, and you mentioned something earlier about having a caregiver. So do they have a care partner with them that participates in the trial with them? Is that what works, or is it just any but I mean is are they an official partner in the trial or or not? Yes, that’s actually an excellent question and thanks for bringing that up. With with with trial for dementia, many patients, by the nature of the disease, or at a point where they’re not able to assess some of their own symptoms, and so it is a requirement of the trial and also really important for their care and safety that they have a care partner who’s a regular participant in their care and this could be a spouse or another family member, or it could be a private caregiver, as long as somebody who’s with them, you know, most of the time and can observe their changes in their symptoms over time. Sure, and they would be coming with them through the to the visits for the child. Yes, and obviously you know. I know that that’s really key in the fact that that person is there every day and they’re seeing probably situations that the actual participant doesn’t even notice. You know, I know with my mom, she had vascular dementia, but I know with dementia there’s certain things. I knew my mom, you know, I could tell that. You know, I could tell she’s getting a uti because her dementia would get more pronounced. You know, different things like that, because I was clued in and I think you know a lot of our listeners we may have, you know, they may have a loved one that says well, you know, this could be an important thing if any kind of clinical trial, and I think the really cool thing about doing these trials is really having somebody that’s with you that’s can really help to hone in on, you know, the progress with you and as is your advocate in this process and just from a clinical standpoint. One of the more frustrating aspects of these diseases for both patients and their care partners, family members, spouses, is that the disease itself affects a person’s ability to reflect and recognize their symptoms, their own limitations, which can be very frustrating for both people because, you know, one person says I can do this just fine and then it’s obvious to somebody else that they really can’t, and that creates a lot of tens and you know, it’s that sort of thing that really drives the need to develop these trevements so we can hopefully slow down the progression and avoid that stage. HMM. Well, and I think, I think that, you know, what we’re talking about here is really important and and you know, I want to go into our last segment as let’s talk about misconceptions about trials and then really let’s talk a little bit more about, you know, how you can get involved in it a little bit more and a and just really who you’re looking for. You know, who fits the criteria for a trial. And in the meantime, Dr Burdick, how do we reach you? Yeah, sure, so mentioned beginning of this segment the best place of the website, the shape trialcom, and also at Evergreen healthcom slash research, and I’ll throw in the phone number this time too, if they want to reach our research department. It’s fo five eight ninety nine five three eight five and they can ask about the shape trial. Well, I’m excited to get in a little bit more into this and and just to remind every one of our listeners that you know and working with the theory Farma. They work with in conjunction with the University of Washington Medical Center as well as the Evergreen Hospital Medical Center, and they also have doctors throughout the world that are conducting similar trial. So if you’re in another city, reach out and look on the website to this shape trialcom and see if you are in the you know, if there’s a clinic near you, because this is an important study, it’s important work and we’re excited to at least be the bridge to make people aware of it. and Dr Burdick, will you stay back with me for one more segments? We finished out our hour. I’d be happy to absolutely you’ll be right back everyone right after this. 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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Originally published May 15, 2022

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