Clinical trial for Lewy body dementia, part 2

*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 everyone back to the answer for elders radio network, also heard, by the way, on all of your favorite podcast platforms as well as this station. And we are so excited again to be talking about something we haven’t talked about a lot in our sixth year, believe it or not, on being on air, and so I’m excited to bring in a new topic that I know about as much as a you know, ahead of a pin on. So I’m learning about it and we are here with Dr Daniel Burdock from the Evergreen Health Medical Center, who is a clinical research physician that specializes in brain activity. I guess is better term about that that that’s amazing, and we are here talking about Louis Body Dementia, and so, Dr Burdock, we talked a little bit about why participated in a trial and what is involved, but I would like in this segment to talk a little bit about the actual trial itself. What is all is involved in that ture. So I think the first thing to say is that, as I mentioned earlier, participating in a clinical trial, I would really view it as as a donation of time. So in the kind of global effort to develop better treatments for Parkinson’s disease and the mention with Louis bodies, we need both donations of money and donatian donations of time, right. And in participating in a trial you’re giving your time to the do that effort to develop better treatment. So it can be a an involved process to be an a clinical trial. You know, in the case of the shape trial that we were talking about here with the Fira, it’s a six to eight months process, over which time the participants would have nine to ten visits, so roughly one visit every four to six weeks, okay, and they’d be coming into our site in purpland they’re depending on where people are coming from, there could be a little bit of travel time involved. And then when they’re here with us, because we spend because we’re so interested in establishing safety and efficacy, we go through a lot of evaluations, spend a lot of time with our patients and so each visit, you know, can be anywhere from a couple to several hours. So it really does, like I say, really is a valuable donation when people give their time to these well and and attended to your own progress of you know, of health things are working. I know, especially for older adults, one of the things that’s so difficult at times is that doctors don’t spend enough time with them, you know, to explain things fully. I know that when you’re in a trial like this you’re going to get a wealth of knowledge and a wealth of attention to your symptoms, what’s going on, how it’s progressing. But also, I’m I’m positive, I just I’m making an assumption, you’re going to be doing a lot of explaining about what’s happening to that individual. Is that correct? Yes, that’s definitely true. You know, one of the reasons I do these trials that I still at my time between seeing patients in regular clinic and then doing these clinical trials. And one of the things I like about the trials is that I do get to spend more time with people and really ask more detailed questions, and here they’re more detailed explanations and certainly really gets an opportunity to get to know people and their experience with Parkinson’s disease or dimensional Louis bodies in much greater detail and I think you know, generally the feedback that we’ve gotten from patients who’s gone through these trials has reflected that, that it’s been a real positive experience because they feel really connected. You know, they’re matched up with a research coordinator who becomes their navigator through the trial. I love that rect access to them on phone or email and it’s I think, quite honestly, and though I wish it were easier in the clinic side, I think it really is a better experience for communicating with our staff on the research side. Well, it is because, especially today, you know, you call a doctor’s office, you’re lucky to get a call back because they’re so jammed with everything. On the clinical trial side, you probably have a question that’s immediately accessible to get an answer. It’s a very different dynamic because you’re on a different you know, it’s not the patient flow, it’s it’s actual research, and that’s you want to have those questions come in. You want to have that interaction. I’m assuming it’s that the object objective is different, is it not? Yeah, I mean certainly we want to hear how our clinic patients are doing and absolutely cern want to get them, but but no, you’re absolutely right that on the research side there’s just a different a different means of communication and it’s who there. It’s faster and people really do feel more connected to the clinic when they when they are in the trial. Got It. Got It. So when somebody signs up in a trial, obviously you’re evaluating a drug or per se, and maybe more than one, depending on what kind of treatment it is. So what happens if you have like multiple treatment groups? How does it work and how do you measure it? Yeah, that’s a great question and of course it depends on the trial. But in this case of the shape trial that we’re talking about, there are several different methods of measurements. So and I guess you could divide them into safety and efficacy. So on the safety side we would do things like form a basic physical exam and neurological exam at the beginning and multiple visits and at the end we’d be checking labs. With many of the visits, so blood draw like you would get after your, say, annual visit or something like that, checking all the basic labs. We would be getting kg on multiple visits to make sure that there are no changes in the heart rhythm. So that’s the safety side. On the efficacy side, again, multiple ways of measuring effectiveness. We have a number of scales, so basically standardized questionnaires that review many, many, many symptoms and Parkinson’s and demention with Louis Buddies in very objective and concrete ways. And so we have those very standardized questions at the beginning, at the visits, throughout the course of the trial and at the end, and then we can compare beginning an end. Now, in the case of the shape trial, we’re actually using a very interesting way of assessing efficacy and that’s an Eeg, called an event related potential. That’s measured by an Eg an EG is where we’re measuring the brainways. Basically we put Scalpe electros on, so it’s noninvasive. It’s similar to an Ekg for the heart. We just put kind of sticky electrodes on the head and actually in this case there’s a cap or a yeah, calf was electrodes in it. You just put on and measure the the brainways, and that is another way of a testing the both beginning throughout the trial, then at the end and then the fundamental point, and this gets to another question about that people have about participating in clinical trials. Fundamental point is that you probably know, it’s difficult to say for any one individual, well, what does this change from the beginning to the end really meet? Is this what they would have had any way had they not been in the trial, or is this better? Or is it likely, but is it worse? So it’s really hard to say that with any one individual. The point of the trial is to gather a whole group of people together. Right. This is why volunteers are so important to put out plug in, because we need a lot of people to really make this a sessions. If, by comparing the changes in different groups, we can see whether the high dose medication had more effect than the lowdose medication and with a lodose medication had more of an effect than the placebo, the sugar still sugar injection. So that that’s the fundamental answer is, how do we really tell if it’s effective by comparing a group that got the medication to a group that didn’t get the medication? And that is the shame. Obviously part of it is is that if you have it in test groups like that, there is going to be probably one group that gets what’s called a placebo correct? What does that lean as a placebo? Yeah, so, so in the case of this of the shape trail, there are three different groups. There’s a high dose, the lowdose and then a placey group, Placebo Group, and you have a one and three chance of getting into any one of those groups. It’s also I know, the physician doesn’t know, the patient doesn’t know, study coordinator doesn’t know who’s getting what. It’s completely blinded, is the term. You know. What does it mean to get to placebo? Well, it just like any other group. It means you’re contributing your time to answering a really important question that will improve the treatment in the future, and having that placebo group is essential to really understanding of medication works. If that’s the case, does that mean that they don’t get any care at all? Is it? What happens at that point? Well, you get exactly the same care. You’re just you’re getting a medication that’s not an active medication. Okay, we’re still doing you’re on other forms of medication to Yees. So you’d be on the same medication that you are on at the begin you can continue those medications right. Anything that onto coming in you can continue going through. Yeah, so, yeah, that’s the important, the important remember well, and the other thing I mentioned was along the line. Sorry, go ahead of tryout second but in the case of the shape trial there’s what we call an open label extension afterwards, and so that’s where you finished the six to eight months of the placebo controlled period and at the end of that you have the option, it’s optional, but you have the option of continuing into a phase of the trial that where you know you’re getting an active drug. Everybody gets the active drug at the end. So if you choose, can go into that portion of the trial and know that you’re getting the actual drug. He would have, Yees, see what its effect on you. Yes, well, and you know that’s important because obviously, in just seeing the whole picture and how things come together, you know it’s understanding when you go in what’s going to happen, and I think that’s really important and I think in our next segment, Dr Burdick, I would love to talk a little bit about now, while you’re in the trial, you know what is it involved, what what are what’s kind of what kind of successes? If you seen in other types of clinical trials of this sort and certainly talk a little bit about treatment and how it progresses. So Anyway, Dr Burdick on. I’m we’re going to be back very soon 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