Joining an Alzheimer’s or Parkinson’s Drug Trial

*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 Theorra Farma and answers for elders radio and welcome back everyone. Two answers for elders radio network with Dr Michael Mega, on behalf of a Thera Farma, talking about Alzheimer’s and Parkinson’s and and dementia trials. And trials are amazing because obviously you’re it to to participate in a clinical trial. You have an opportunity to be at the forefront of treatment. That is fascinating to me and certainly I’m learning a lot through working with a theora and all of the stories that I’m hearing from the different doctors around the world that I’ve had the privilege of interviewing. And we have just spent the last, you know, half an hour with Dr Mega and I am so glad that you’re here with us for this final segment and I am looking forward to learning about the trial that you do tell us a little bit about the clinical trial that’s being offered right now for those that have been diagnosed. Okay, thank you so much to them. It’s a pleasure to share this information that theory Farma has essentially instigated. They have a fascinating molecule that has dual action. It’s called at seventeen and it’s an injectable drug that is given subcutaneously daily to patients that have potentially any kind of type of degenerative brain disease. It’s being utilized in people not only with Alzheimer’s disease in the midstages of the disease, and also with people who have Louis Body disease and Parkinson’s disease. And the reason why it’s given to people with different causes of degenerative brain disorder is because it works as both a activator of the glutaminergic transmitter system, which helps us well in terms of it helps us increase our speed of processing, but it also works downstream in as a nerve growth factor on the hepatosite receptor that’s throughout the brain, the patosite growth factor receptor that’s throughout the brain. That would hopefully increase the connections between cells. So it has an immediate effect that speeds up thinking and processing and it has a more long term effect that increases the connections between brain cells. So if you can imagine those connections being prune by the degenerative process in both people with Alzheimer’s disease, Louis Body disease and Parkinson’s disease. It tries to mitigate that pruning and increase the connections being made. So thus it’s facilitating growth of neurons and their connections in the brain, so easing thus this medication should be beneficial for any type of degenerative brain disease. Make Sense. That’s why it’s being tested in these three different degenerative brain disorders. Yeah, and obviously to participate in this trial either qualifiers that you look for to bring somebody in? What? What are you? What is the ideal candidate to be involved in a trial? Right? Well, for any trial that’s that is having oversight by the FDA to prove efficacy in a degenerator brain disorder like Olzheimer’s, like Parkinson’s, like Louis Body disease, somebody needs to have a study partner. So you know, unfortunately people with diseases like that sometimes they live alone, and so that is that is going to not allow them to take part in a trial unless they have somebody who is can be their partner, that is with them for a minimum of ten hours per week to observe how they function throughout the day. So that’s one of the main requirements. So that would be like a spouse or adult child or you know somebody, yeah, a close friend that comes in every day checks on them, things like that. Okay. So also other requirements are that their stable on their medications, and so that’s key that during the the treatment trial we don’t want to have so many variables that would somehow interfere with the observation of how their function is. All that makes sense. Yeah, so these trial, the trial with a th and seventeen that a theory has developed, has a blinded portion. You can get either low dose, high dose of the medication or no dose, and so thus it has three arms. So there’s a thirty three percent chance during the six months that the blinded portion of the trial last that you would be on no dose. After that, however, you get your the high dose of the medication for sure, sort of as a thank you for going through the Bodom portion. The other requirements are that somebody has memory or thinking problem associated either with Alzheimer’s disease, Parkinson’s disease or Lewis Body disease, and so it’s required that the study partner has observed changes in function that would suggest a person is no longer safe living by themselves. Thus they have dementia. Okay, so study partner required. Having a thinking problem severe enough to cause a dementia required and also request. Fired is the sixmonth blinded portion, where there’s a thirty three percent chance of being on no treatment, but then after that six months a hundred percent chance of getting the treatment. Got It. Got It. So in that kind of trial, obviously you’re getting if you’re in the two thirds group. Obviously, even in the blinded segment, you’re going to have this amazing opportunity to experience probably the most breakthrough and and wonderful opportunities. But it’s also safe and that, I think this is something that people think, you know, are you going to put, you know, shock treatment on me? And I there is something like that. This is stuff that’s already been tested to be safe. Correct. So tell me a little bit about like the testing process when we go through a trial like that. What happens? Well, so AFIRA has our, as you said, already proved safety in humans with this drug. Safety typically is done during phase to testing, and so the biggest side effect of getting this injection daily. Remember it’s a shot. So kings injection daily is some people get itching at the sight of the injection and that can be mitigated with either cold packs or steroid cream or taking an antihistormy, but otherwise we know that the medication is safe for humans. The up the other thing that’s required and can be an inconvenience is the fact that we’re trying to figure out if it helps with thinking. So Pencil and paper testing is done during the six month period to see if the treatment group gets has a greater improvement than the Placebo Group on Pencil and paper testing, as well as on caregiver observations, the Study Partners Observation of daily function, and so those take time and so requires and a visit to the clinic that’s doing the the treatment trials in the patients area and can be a little, you know, annoying to be asked questions it. So that can be an income that it is important, obviously, and and you talked about a visit to the clinic. How often do people go to visit on you if they’re on a trial, and how do you supervise them overall, I mean through that process. So anybody WHO’s involved in a clinical trial is going to get the best observation of their health condition that they’ll ever have, believe me. And so the reason being is because you want to make sure that you understand what’s happening to the person during the trial compared to the placebo group. So for people to come to the trial in my area, as well as other areas, you will get the cell phone number for the physician who’s the private primary investigator for the trial and anytime you go to the hospital for a broken ankle or a toothache, you’re any you stay overnight, you’re supposed to call my cell number. So I tell the FDA in the study sponsor. So you can see that there’s very close observation of your health. The other thing is it’s important understand the the study partner is asked to pay attention to you. So you get very close surveillance by your study partner because the outcome measures are going to be important from what their observations are. You for this particular trial, you will come to clinic about once every two weeks in order to get new medication, but you’re not tested except for about once every two months, and so they’re in the six month period, there are frequent visits to the clinic. Yeah, yeah, and so obviously picking up the medication, obviously that’s a quick in and out. But if someone let’s say, for example, they live an hour away, do you have any programs in that or do they have to make that our drive? Just to be specific? Well, there is, luckily reimbursement for study visits, and so both the partner as well as the the participant will get money to offset the transportation and inconvenience. But you’re not going to make it’s not going to make you rich. No, it no. Obviously well, and it probably does for your gas cost. That’s well, and gas is important these days, let me tell you, especially the cost of gas. So so, obviously to sign up for the program I really want to talk a little bit about by participating in a trial you’re getting the advantage, yes, of innovative technology, but even more importantly, you’re paving the way for cure and I think you know, one of the things that I am really excited about is that I do believe with all of the interviews in an individuals that I have met and where we are with these trials, there will be a cure someday for Alzheimer’s disease. I believe that with in my heart, and I also believe that we’re on the way to, you know, to cure of so many brain related illnesses and certainly, Dr Mega, I am so thrilled that you’ve spent this time with us today to just kind of talk a little bit about. Yes, it’s important, but even more importantly, what you’re doing to to bring medical research forward, and I think that’s the exciting part about, you know, having that legacy of being one of those people that have helped bring, you know, a cure forward, and I think that’s something that’s so important. So, Dr Meggat, thank you so much for being on the show today with us. My pleasure to exam and were those of you that are interested in the trial. I’m going to give two websites out, okay, number one, www ad trialcom. That’s www dot L ift, like Tom AD stands for Alzheimer’s Disease Trialcom, and wwwcot shape trialcom. So please, no, reach out to a Thea, reach out to the study, find out if you might qualify. And we’re so pleased to have Dr Mega with us today and thank you so much to each every one of you and take care of the preceding podcast was provided by a the reformer and answers for elders radio. For more information about the Alzheimer’s clinical trial, go to a thera clinical trialscom