Suzanne Newman joins Dr. Cherian Verghese, Principal Researcher at the forefront of Alzheimer’s disease at Keystone Clinical Studies LLC in the Philadelphia area. This segment focuses on types of clinical trials and what’s involved in participating.
In the phase of informed consent, participants and trial partners are appraised on details about the medicine, that it’s voluntary, outlines potential side effects, not charged to insurance, that participants can withdraw at any time, and that they can also talk to the ethics committee at any time. A trial partner spends time with the participant, a family member, friend, or neighbor — conducting the study needs someone who can tell us about how the participant functions at home with their activities of daily living.
There are prevention trials, for people who have beta-amyloid proteins in their brains but show no symptoms, which are to remove the amyloids and counteract them. The most important area of research is for those with mild short-term memory problems, people who repeat the same story, forget mundane everyday things, and rely on a cell phone for reminders. Athira Pharma’s study, for those with mild to moderate Alzheimer’s, is for a drug that’s intended to help regenerate the brain, deal with the damage that’s already being done.
If you know of someone with Alzheimer’s, there’s probably a trial available for them. For those interested in a trial, visit Lift-AD Clinical Trial to learn more. You can learn more about Keystone by calling 610-277-8073 or visiting Keystone Clinical Studies LLC.
View Episode Transcript
*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 Themera Farma and answers for elders radio. And Welcome back everyone, to answers for elders radio. And we are here again with Dr Vgie and he is a clinical researcher in in this wonderful outside, the wonderful city of brotherly love, Philadelphia, Pennsylvania, and I am so honored, Dr Verghese, to spend some time with you because of your amazing background in neurology and research. And you know, I would love to like the a mouse in the corner when, you know, breakthroughs happen, because there’s there, there are things happening every day and at twelve of our listeners. I’m very, very lucky because, through a theory farmer, I’ve had an opportunity to interview some of the top doctors in, you know, not only in this country but in the world, and it’s been very, very exciting for me to take the time and talk about, you know, what is being done and how we’re we’re making progress and we really, really really are, but it’s also takes, you know, the participation of each and every one of you. If you have a connection to someone with Alzheimer’s, and so I want to take Dr Verghee welcome back to the show and certainly I want to talk to you a little bit about clinical trials. You know, we hear about them and people go, oh, that’s interesting, but I don’t want to be a Guinea pig. There’s a lot of different kind of hesitancy of what, you know, what’s expected in me if I enter clinical trial. So, you know, can we back up first before we talk a little bit about the specific trials that we want to talk about today? What is involved in a clinical trial? Sure, so you’re absolutely right. There’s a lot of fear misconceptions about clinical trials. I speak at many senior centers and retirement communities and ask them what is the what’s the first association with clinical trials, and people will quietly say hope, new treatments so on, and I say okay, tell me what’s really in your mind. Then you hear Guinea pig, Guinea pig, Guinea yeah, and with a kind of embarrassed laugh, and I say look, the one difference between a guinea pig and a trial participant is that guinea pigs don’t consent. Right, okay, and having been a physician for close to forty years, I do believe that folks and clinical trials having much better understanding of what the disease is, what the treatments will be, what the options are, then someone going to an average medical encounter right. The first thing, especially with the the experience with people of Color, with the American community, is that they were bad things that happened. Okay, and there is something called the tuskegee syphilis study, which was conducted, I think in the S and S, where poor African American males, mostly from Tuskegee, Alabama, who had syphilis were not treated just to see what the outcome of the diseases and it’s really is a horrendous thing to do because there were treatments then and there was nothing great to be learned. We knew everything we had to know about syphilis in the eighteen hundreds. So that was a bad thing that happened, but you know, if you go back fifty hundred years, lots of bad things happen and society has moved on. We have moved on. We, I believe, have a much more inclusive and participated society. It’s not perfect, but we’ve made a lot of strikes and aqually in the area of research, we have a very strong ethical underpinning to what is called the informed consent process. So anyone who takes part in a clinical trial has to sign, has to be explained, the inform consent form. They and an Alzheimer Studies there. Their family member or study partner also sign that consent form. So basically it is the praising people about their condition, the illness, what this medicine about. is about to tell them that this is experimental medicine, is voluntary. You can change your mind any time what the side effects are of the drug. There’s also a part where, you know, they have the ability to talk to the like an umbudsman like. If they are happy with the way we are treating them, they can talk to the ethics committee. That’s wonderful. And they’re also told that if they have a side effect that needs in outside medical k the sponsor will pay for that. That’s amazing. I’ve seen that happen. You know. We’ve had people with side effects and the sponsor comes in and pays for that and that we are not billing their insurance, they don’t have a copay and they can change your mind at any time. So it’s a very comprehensive document and it’s scarred by an ethics committee or an Irb an institutional view board. And all of this is under the supervision of the Office of Human Research Protection, or HRP, under the FDA. So the line of Regulatory Control and supervision goes all the way up to the federal government. So I do believe that folks who go to clinical trials have, you know, as much information as they need to make up their minds and to withdraw from the study. Right, right. So when you talk about a study partner, you I see you it in on that. What is the role of a steady partner and who is usually that person? It’s someone who spend some time with the patient. Okay, you know, a spouse in adult time, neighbor, it could be a child, who could be a parish nurse who comes and visits them. But look, we are looking at people who have difficulty with their memories, so they may forget to take the medicine, they may forget to report if they have a side effect. So in just the conduct of the study you need someone on the outside. That’s one part, and also the trial partner, someone who’ll tell us about their functioning at home, got activities of daily living, you know, because it’s not enough to help them remember a sequence of words and numbers. They should be able to look after themselves absolutely, and you know, Medicare is particularly concerned about do we have to move them to a nursing home? Yeah, you know. Is this drug able to keep them from losing their self? Care this drug able to keep them independent? And that information, you know, are they able to get a meal? Are they able to be safe? Can they choose your own clothes? Can they wash and keep themselves clean? Can they maybe go to a grocery store? All of this information comes from a primary number or, apart, a trial talk. So the product partner has two roles. One is of giving information on the functioning, the other is to be there as a second pair of eyes and years well, and I think that’s important because I know, like with my mom, she had vascular dimensions. She didn’t have Alzheimer’s, but that the thing. What I found was is that she had a hard time comprehending of like when a doctor would say, on a scale from one to ten, how bad does it hurt? Mom always said it was a for and even though she was in massive page she didn’t have the ability to process. Really, how bad is this? And when, when you’re with somebody a lot and you know them intimately, like I did my mom, I knew exactly how much, you know, she needed, what we needed to talk about, because it again the inability to process, in to vocalize what is really going on. Again, we talked about this in the beginning of the of the show, is the fact that, you know, the reticence of you know, in the hesitancy to speak it up because you don’t even have a you don’t understand what it is that you need, and I think that’s having that partner and not going through it alone is really important. Sure, yeah, and so so you know, these are complicated issues, you know. Yeah, and involved can thing maybe twenty pages. Yeah, and I mean when you give a lot of information, it’s also hard to comprehend. So it’s important to absolutely way who can help them with absolutely decisions. And you know, it’s hard to because families are struggling. I know for for I probably talk to at least one to two families a week who are dealing with, you know, a loved one with Alzheimer’s and they don’t necessarily know how to help. They don’t necessarily know who to call to reach out to. All of those different factors are certainly huge considerations and so, you know, trying to help in the best way possible. It’s I’m hopeful that we can do that. So as far as when is a good time, I’m just going to throw it out there. When is it good time to reach out for help or to acquire about a trial? Early stages, midstages, I mean, where are we at? It’s a very good question. So right now in the field we have studies that span the whole spectrum. So this a theory of studies for people with mild to moderate dementia who already shown that they are having difficulty with self care. They clearly have memory problem, oriented but not not at the nursing home level of care where they need everything done for them. Right. But so this drug is meant to help regenerate the brain, to deal with the damage that’s already been done. Yeah, because. So let me go back. So in the field we have studies that are meant for people who are perfectly normal with no out outward symptoms. These are called prevention trials. Remember, I talked about the one in people who are functioning out there. Yeah, symptoms with the AM alloyd. So this is meant to take cared that I’m alloyd, a counteract, that I’m alloyd in people who have not yet manifested symptoms. The most important area is the people with what is called mild cognitive impairment, who just have short term memory problems. You mentioned, you know, ask question again or repeating yourself, telling the same story again, forgetting money. The things that people forget first are mundane, everyday things, not important things. See, because our brains are minds give more value to emotionally important thing. If I ask you, you know, where did you celebrate your birthday last year, you probably will remember, but if I asked you what you bore last Tuesday, you certainly not remember. No, most likely, exactly exactly. It’s the mundane things that we forget. Yeah, and that can often be confused for a senior moment. Yeah, like I have a lecture that I have entitled senior moment or Alzheimer’s disease. Well, so it’s forgetting things, repeating yourself, needing to use your cell phone. People now use this as a what I call the proopheron brain. Yeah, as soon as they know they have to do something that put it in the cell phone, which would remind you. So that short term memory aspect is taken over by your cell phone. Yeah, okay for functioning, but it delays diagnosis. So for Allse of you that are interested in a trial, go to www dot lift. That’s L if T and there’s a AD which is stands for Alzheimer’s Diseasecom lift adcom, and we’re going to come back this very last segment. What’s available right now? How can you get involved on get your loved one involved and let’s find a cure for this disease. and Dr Geese and I will be right back 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
Listen to More Answers for Elders with Suzanne Newman
Keep an eye out for future Answers for Elders podcasts on the Senior Resource Podcast Network! Thanks for listening, and be sure to keep scrolling for more articles by Suzanne. For more AFE podcasts, visit AnswersforElders.com and subscribe on your favorite platform!
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.
Connect with Suzanne
Visit AFE on the web: https://answersforelders.com/