Dr. Richard Marshall, PA, progressive medical researcher in Port Orange, Florida, talks about how the new use of the RetiSpec system and how it can lead to diagnosing Alzheimer’s early. Marshall discusses from the topics of what the RetiSpec is and what it looks for, as well as discussing the patients John and Sylvia Whitley.
Interview conducted by Ivanhoe Broadcast News in June 2022.
In terms of diagnosing Alzheimer’s, what does a patient have to go through?
MARSHALL: Well, to truly make a definitive diagnosis of Alzheimer’s, they need to either undergo an amyloid PET scan or a lumbar puncture. Both of those things, the lumbar puncture is uncomfortable, to say the least. The old phrase for a lumbar puncture is a spinal tap. It can be painful. It’s not done everywhere. PET scans are very good as far as making the diagnosis, as good as doing biopsy of the brain tissue, which we don’t do on living people. But they’re very expensive; upwards of $10,000. Medicare doesn’t pay for it. Insurances don’t pay for it. A radio tracer is used to attach to the amyloid plaque that may have built up in the patient’s brain, and that is only produced in certain places around the country. Not every imaging center can do these PET scans. Not every radiologist can read or interpret them. They’re very expensive. And for some places they’re not easy to get. It’s not a readily available way to diagnose this.
Why is diagnosing Alzheimer’s early so important?
MARSHALL: Well, with any disease state, the sooner we can address it and do things to mitigate it, the better results you’re going to have, the better you can potentially slow, stop. We’re not quite at the point of reversing it yet, but there’s a lot of drugs and studies right now that are having very favorable results. As those come to market, the sooner we can make a diagnosis and a definitive diagnosis that the memory problems are truly the Alzheimer’s type, you can get them on a proper treatment.
Can you tell me a little bit about the RetiSpec and what you’re looking at here?
MARSHALL: So the RetiSpec system is part of a larger trial called the Bio-Hermes trial, which is put together by the Global Alzheimer’s Platform. And essentially what it is, it’s a study where we take subjects who may be maybe having problems with their memory, for sure are having problems with their memory or are totally cognitively normal, and we do a litany of memory tests, blood tests that are looking at various blood biomarkers. And the RetiSpec scan, in an effort to find people that have markers that perhaps will correlate with a PET scan that they then get done as part of the study, as well. So by having a large group of people, we’re trying to find what blood test or blood levels will predict who has the PET scan that is positive for amyloid. Thus, we would have a much easier way to detect accurately and earlier people that have the amyloid plaque on a PET scan.
Can you describe how the machine works?
MARSHALL: Sure. So the RetiSpec is a special multispectral camera that images the retina with many, many different wavelengths of light. Then they have artificial intelligence that reviews those images and can see the buildup of the amyloid plaque on the retina. So it’s essentially like taking a picture of a window into the brain.
How accurate is this?
MARSHALL: Thus far, from the data that I have from RetiSpec, they’re in the 90 plus percentile at predicting people with a positive PET scan.
How early can these pictures tell a clinician whether or not someone is at risk?
MARSHALL: Well, we know that people start developing the amyloid plaque in the brain 10 to 20 years, upwards of 10 to 20 years before they start having problems. And we know this from numerous prevention studies we’ve done over the years, where we have normal people that get PET scans, that we see the amyloid plaque and then they’re followed. So that’s kind of not a theory anymore. So we know it’s up to decades before they start having problems.
And are there medications then somebody who is at early or at high risk or when clinicians start to see these deposits, are there medications, does that help at that point?
MARSHALL: Currently, there is only one FDA-approved medication that removes amyloid plaque. It is not approved for prevention. CMS, which controls what Medicare pays for, has made it very difficult to get that medication approved. So there’s no treatment right now or prevention medication. The FDA-approved meds such as Aricept or Namenda don’t do anything to prevent the physiologic changes. All they do is boost the neurotransmitter in the brain. So, it may boost people’s function and ability for a variable amount of time for a variable amount.
Can you talk to me a little bit about what this is like from the patients end?
MARSHALL: Well, so as part of the Hermes trial, they come in, they’ll do about an hour and a half, two hours of some various memory testing. And then we dilate their eyes and then they sit across from the person that’s doing the exam. And it’s very much like getting a regular full eye exam at the ophthalmologist. They take about 15 to 20 pictures of the eye. Most of the scans are completed in 15 to 20 minutes.
So no pain, no discomfort?
MARSHALL: There’s no pain. There’s no discomfort.
What are the next steps? I know you’re still recruiting, but how will this work from this point on?
MARSHALL: So as we finish filling the study, they will statistically analyze the results. You know, and RetiSpec, the company that is doing the eye exam, they will have their predictive on whose PET scans are positive. And then the statisticians will then go back and they will decide how accurate. So with that data, they plan on going to get approval with the FDA, hopefully within the next year for a new medical device.
Can you speak to me a little bit about John?
MARSHALL: Yeah. Mr. Whitley and his wife came to us. They both had feelings that they might be having some memory problems. They had been seen at another facility a few years prior. Both of them, actually, incidentally, had had lumbar punctures. His was negative at that time, but they still felt that there was something going on. So we brought them in for the study and he qualified and went through the whole process and did have a positive amyloid PET scan. Currently, now he’s on one of our treatment studies, which is good because his level of function is still very good compared to most people. So the big thing is the sooner you can start treatment on people before the disease starts really ravaging the brain, I liken it to stopping a snowball before it starts getting rolling down the mountain.
Does Mrs. Whitley also have – is she also at risk?
MARSHALL: Actually, when she did her testing, she did too good to go on to the study. So.
Is there anything I didn’t ask you that you would want to make sure that people know?
MARSHALL: Well, I think just in general, and particularly with this, you know, to be able to have this technology available at any office or any ophthalmologist’s office, to be able to really help clue in people that they may be at risk to develop this, you know, the amyloid plaque and then down the road Alzheimer’s, would be great. Something like 50 million people across the world have it. It’s supposed to go up to something like 190 million in the next 15 years. And with any disease, no different than how we’ve treated and affected heart attacks by using statins to prevent heart attacks, getting on a treatment, developing a treatment, being part of a clinical study, I think makes a huge difference. You know, in the course, in the potential course of the disease for people. So having that quick, easy way to get an image and evaluate your risk, I think is just wonderful.
Is this testing or because it’s a clinical trial?
MARSHALL: Well, because it’s part of a clinical trial, it’s not. Once they get FDA approval to be used as a medical device, then that would be the next step.
Is to get it to the point where it can be approved.
MARSHALL: And then insurance companies pay for it. Medicare. You know, and that is one benefit of being in a clinical trial, is people get all this testing, all this information, you know, at no cost. And a large part for people that are concerned about their memory, they can get these different tests to help them get more information where there’s no way that they can get them without being on a trial.
END OF INTERVIEW
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