amyloid_pet_example

Q&A: Dementia Expert and Radiologist Share Their IDEAS Study Experience to Date

 

Bright IDEAS spoke with Erik Roberson, MD, PhD, and Jonathan McConathy, MD, PhD, from the University of Alabama at Birmingham about their experiences in the IDEAS-Study. McConathy is an radiologist; Roberson is a neurologist. They address important topics, including:

 

  1. Patient/participant satisfaction
  2. Paperwork
  3. Reimbursement

 

(Bright IDEAS): Please describe your experience so far with the IDEAS Study.
(Roberson): It has been great for us. We have been talking to our patients for years — I can’t tell you how many times [someone says] “I might have Alzheimer’s disease,” and I’ve had to say that we don’t have great ways to look at the pathology inside your brain. Now we have this PET scan, but it is not covered by insurance. It costs upwards of $5,000 if you want to do it. Of course, I don’t say it quite like that, but that is the basic conversation. Honestly, nobody really wants to spend that kind of money. And so we haven’t incorporated it into our clinical practice at all. The IDEAS Study has been a great opportunity to do that.

At this point, I’ve had three patients go all the way through to the post-PET visits. I have probably another three who are about to get their PET scan or who recently got their PET scan.

(Bright IDEAS): Have there been any challenges with identifying your patients to refer to the study? They have to meet the amyloid PET “appropriate use criteria” (AUC) in terms of having the uncertain diagnosis, correct?
(Roberson): They do, yes. Many of the people with mild cognitive impairment (MCI) have fallen into that category. It can be hard to feel confident about the cause or causes of MCI. Sometimes in people with mild dementia, we have a stronger suspicion that Alzheimer’s disease is really what is going on.

The dementia cases I referred to the IDEAS Study all had something kind of unusual about them that raised concerns. One had another neurological disease that made the clinical picture unique. Eventually, the presence of amyloid in the brain suggested that it was really Alzheimer’s disease.

(Bright IDEAS): It doesn’t sound like the AUC has been an obstacle at all.
(Roberson): It is a subset of our practice. We see a lot of patients in our clinics who we think have Alzheimer’s. We’re not referring them to IDEAS because we can’t honestly say that a positive or negative scan will change our management. So the AUC is definitely a factor. It is something that we are aware of and we incorporate into our decision making on who we refer. And it definitely limits the number of people that we refer, but that is what it is intended to do.
(Bright IDEAS): How long have you been registered in the IDEAS Study, and how many patients have you referred?
(McConathy): We were officially up and going in May 2016 and started scanning either late May or early June.
(Roberson): I believe I have personally referred six patients to the study.
(McConathy): We’ve done around 20 imaging studies total, so far.
(Bright IDEAS): How have you found participation in the study? How has it been to engage your people, and to conduct and report on the PET scans?
(McConathy): From an imaging point of view, it has been relatively easy. There was definitely some modest set-up — the PET readers need to sign an informed consent because data is collected on their reads. So the physicians involved have to be enrolled in the trial.
(Roberson): I think this is probably the first time that we as physicians have signed the consent form to be in the research study. We are in an unusual role — both roles, really; the investigator in the trial and a research subject of the trial. It is unlike most of the trials that we do in that it is right at the interface between clinical practice and research. It is a research study that is almost completely incorporated into clinical practice.
(Bright IDEAS): Has there been anything that surprised you about participating in the IDEAS Study?
(Roberson): Not having done a lot of amyloid imaging on my patients before, and so not having really gone through that process of rigorously explaining to the patient about what an amyloid scan means. Pointing out that a negative scan means you don’t have a burden of plaques in your brain, which basically means you don’t have Alzheimer’s disease. A positive scan means you do have plaques in your brain, but doesn’t necessarily mean it is Alzheimer’s. Going through that thinking and explanation with the patient, and seeing how information really gets impacted into clinical practice.

My initial scans were positive. When I get one that comes back negative, it will be interesting to see how that counseling session goes. It has been very interesting to experience this information flowing into and becoming part of the exam room discussion, rather than speculation based on a structural image and some cognitive tests.

(Bright IDEAS): After sharing the amyloid PET scan results, do you find that patients and family members learn more about the disease? Do they appreciate having the information?
(Roberson): One of the most valued things we provide in the memory disorders clinic is education about Alzheimer’s disease and dementia. The patients certainly benefit from the drug management we provide. But the education — knowing what is going on and knowing a little bit about why it is happening … Some of the greatest satisfaction I get is from sitting down, taking the time to explain the situation to patients and their families.
(Bright IDEAS): Can you talk about how the amyloid PET scan results have been received?
(Roberson): It varies a bit. I haven’t yet had any super dramatic reactions. Many of these families are used to dealing with uncertainty. Often family members have been symptomatic for years and yet no one has been able to say, “This is what it is.” They get, “It could be this; it is probably this.” Not that a positive amyloid scan completely answers that question, but it does say, “Yes, you have amyloid in your brain.” It helps facilitate some acceptance that Alzheimer’s is the problem. There is clearly an appreciation that the answer to the question is becoming clearer. There is more definitive information on the table that amyloid plaques are in the brain. And the patients and families, in general, are very appreciative of being able to get that information.

Here’s an example:
A patient who was becoming symptomatic and didn’t have a definite diagnosis was responsible for caring for another loved one in the family. We’re looking for prognostic information, because we had to make a decision about whether the symptoms were likely to be stable and they can perhaps continue to provide care, or whether they are more likely to continue progressing, and the family needs to start thinking of alternate arrangements for the person they were caring for.

(Bright IDEAS): What do the amyloid PET scan results give you as part of your decision making process as you make your diagnosis?
(Roberson): The negative scans carry more weight in that they are essentially incompatible with a diagnosis of Alzheimer’s disease. The positive scan is less definitive about the diagnosis because of the possibility that the amyloid there is still in a preclinical stage and is not the cause of the cognitive symptoms. This is information that we simply have not had before.Up until now, we have been kind of flying blind about molecular changes in the brain. This is the first time we have been able to effectively incorporate that kind of information into day-to-day clinical decision making and the conversations we are having with individual patients.
(Bright IDEAS): Dr. McConathy, is there anything you want to add?
(McConathy): From the imaging side, having a clinical tool in the radiology and nuclear medicine community gives us a different conversation to have between our group and the memory specialists here. It is no longer just a research tool; it is not something off on the horizon — it is something we are using. It has stimulated interesting conversation around neuroimaging in general, which has been positive.To actually operationalize clinical amyloid PET is going to be informative. Gaining clinical experience with the technology will inform the referring physicians and the imagers by providing real-world experience and information about how this impacts real patients in real time.

When therapies that slow or stop the progression of Alzheimer’s disease become available, it’s going to really change the landscape of amyloid PET — particularly if knowing amyloid status is key to using the therapeutics. By establishing a baseline of clinical experience, centers will be more ready to participate in using amyloid imaging in that context.

Around 80 percent of cases are easy. But those 20 percent that are not clear cut are challenging. Having some experience through the IDEAS Study is helpful for the readers. When therapeutic decisions are being made, the readers will be much more confident. Also, the neurologists and memory specialists will be more familiar with using amyloid PET in general, and with how to handle ambiguous cases.

(Bright IDEAS): What would you say to those imagers and dementia experts who have heard of the IDEAS Study but are reluctant to get engaged?
(Roberson): We had a little bit of an issue early on. There was a patient without supplemental insurance who had a substantial $800 or $900 co-pay for the scan, and they were surprised by the size of the charge. Since then, we’ve tightened up the way that we explain this to people up front. We emphasize in the consent process that this is part of clinical care, and that the usual co-pays will apply, as opposed to talking about it as purely a research study. We give them printed material explaining the costs and work with them to help determine how much their co-pays will be. And we have the PET center go over the costs again when they make their appointments.As far as recruiting more physicians, I would think that people who are truly dementia specialists are pretty interested in having this information available and providing a resource for their patients.

Filling out the forms is not burdensome at all. We have a research coordinator who helps us with that, who gets consent from the patients and usually does the case registration forms. I usually do the pre-PET and post-PET forms online. But last week, a patient got there after 5:00 and the coordinator was gone, so I had to do it all myself. It wasn’t bad at all.

(McConathy): On the imaging side, once you get up and going, it’s very little burden. You need to be able to log in to the website, complete a very brief questionnaire about the study, and upload your written report once completed. But amyloid PET is very straightforward. Any center that does FDG PET for oncology can easily adapt their practice and workflow to do amyloid PET. I think it’s even easier on the PET side.
(Bright IDEAS): Based on your experience so far, what would you tell a peer about the benefits of participating in the IDEAS Study?
(Roberson): First, it enables our patients to receive a service that they otherwise can’t have or can’t afford. It provides useful information to them. Second, this is the future. Having molecular imaging and incorporating information about a patient’s specific biological variables — amyloid status, tau status or genetic information — into practice decisions is the way to the future. It is good to get in on the ground floor.

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