My understanding is that research using PET scans with PIB have proven that the compound binds to beta-amyloid plaques (a telltale sign of Alzheimer's disease). Do a Google image search on “PET scan PIB” to see how dramatic the imaging results are for normal vs. AD brains. In the studies, “the brain areas afflicted by Alzheimer's disease-related changes brightly lit up.” In other words, these scans can visually show Alzheimer’s even early in the disease progression. This imaging technique has been researched since 2002, published since at least 2004, and confirmed in multiple studies. In fact PET/PIB is being used in other research to measure the impact of certain drugs in reducing the plaques. I have questions: Why do I have to subject my DH & myself to a trip to a memory disorder clinic, meeting everyone there (becoming part of that “family” – I don’t want to!), having to spell out all of his issues (which BTW he is seemingly unaware of, so it is going to be a battle), waiting for their conclusions, getting a referral for a 2 hour neuro-pysch test, having to go to another facility for that, waiting for those results, and whatever else comes after that? Why can’t the family physician just send us for a PET/PIB scan, just like he sent us for a CAT scan last year? I know how important research is, and when the time comes will encourage my DH to participate, but I feel like we are being sucked into the research world because we have no choice. If we want a diagnosis we have to submit to it all. Who decides when a proven imaging technique can be used by a family physician outside the research arena? Another question: Why do so many still claim an autopsy is the only way to definitively diagnose AD when the scientists have accepted that PET PIB can spot the plauques associated with AD?
Excellent question. I wish I had an answer, because I certainly would like to know. Anyone out there have an answer?
I DO know that the complete cognitive testing is important to find out exactly where and how they are functioning. The blood tests, EEG, and MRI are to rule out strokes, tumors, hydrochephalus, other diseases, and vitamin deficiencies.
It might have something to do with insurance protocols???? Maybe everything else has to be ruled out before the "powers that be" will pick up the tab? I don't know...but it does seem like it would save a lot of time and aggravation.....
I've been advised that the PET/PIB is being used only for research right now and because it's use is associated with research insurance companies won't approve it's use or pay for it.
Someone in a support group I attending is getting one for his wife and paying for it himself since his insurance won't pay for it. He said it will cost $8000. I know Medicare doesn't pay for them for dementia although they will in some other cases.
Wow! $8,000! I was thinking it would definitely be worth paying out of pocket for one, if I could avoid all the other testing and get a diagnosis - but I was thinking $3000. But $8,000 - yikes! I would be interested as to where he is able to get it done, though, and how he located a place that would do it outside of research. I know the patent owners (University of Pittsburgh) are licensing the technology to GE Healthcare - but I thought GE Healthcare was only using it for research....
On the Medicare, I did read something today that they will pay for it - but only for a differential diagnosis between AD and FLD, and only if about two pages of conditions and circumstances are met - which requires all the other testing anyway.....My husband is only 58, so Medicare is not involved...
He's going to Northwestern University Hospital in Chicago. There is a memory clinic there and I know they do research, but my friend didn't say they were involved in a study. If they were, I would assume the research grant would pay. I read the same thing you did about Medicare - only for a differential diagnosis. His wife has had all the other testing, but the doctors aren't sure if she has Alzheimer's or FTD. He wants to know which it is. He said his insurance won't pay, even in that case, so he is going to.
That's obscene. Especially with a question of AD vs FTD. Because the AD drugs can really harm FTD patients.
Well, I guess I'm just going to have start right off learning acceptance, and accept the fact that I can't protect my DH from all the negative experiences that are to come. This is going to be so difficult for a control freak such as myself....
The other reason I wanted the scan is that it is an undeniable visual picture, that my husband could not argue about. I would much prefer that, to a series of tests that he can argue were misinterpreted, etc. I am so dreading the confrontation, when the family physician gives him the referral to the neurologist. Floating down the River of Denial has not been great for me - but it certainly has worked for him.
My husband was referred to a radiology llab for a PET Scan in 2004 and AFTERWARD, I was told that MEDICARE would not pay for it. Our Secondary Insurance picked up a large part of the tab, and after several visits, the remainder of the charges were dismissed because the clerk admitted she had not advised us that it would not be covered by Medicare which she was supposed todo. I think the fact that Aetna paid over half made the difference. It was somewhere around $9000 if I remember, - and it was a huge shock!! I would not have dreamed it was (1) not covered by Medicare since every other test was and (2) it would be that expensive. I was later told by one Neurologist that it was not "that" conclusive and yet another neurologist was interested in the results and sent to the lab for a copy of the report. I don't know if anyone knows for sure! I reached a point where I believed the only reason he was called back twice a year was simply for research, tracking his progression ..and not for helping him get better (!!!) They rarely adjusted his meds. So, this past September, I cancelled. He died in November.
I'm sure not all the images are this profound, but when I see this, I think THAT is a good tool: http://upload.wikimedia.org/wikipedia/commons/b/b9/PiB_PET_Images_AD.jpg
Marry22033- Pet scans - I requested one for my dw in Oct 09, and it was possibly the best and worse thing I could have ever done. Doctors are reluctant to order one since the cost is $4582, and after getting pre-approval from Blue Cross, they declined my coverage because it falls under "Mental health benefits", which our policy does not cover. I had to write several nasty letters to blue cross, and only after the doctor coded it that he requested the pet scan in order to determine if her breast cancer had metastasized to her brain. The scan however did check for alz vs ftd, and the pictures are wonderful to look at....wish I would understand what it all means....but, the pet scan is also a bit of a pre-obituary notice...it condemns you to death. But when I compared the results to different parts of the brain, I did discover that it matched my dw's behaviors, coordination, verbal and language skills etc,...I have also learned recently that left parietotemporal hypometabolism affects anger......usually patients with right side deficiencies are mild and non agressive...left side is pandemonium at its worse....
Frank, when you say you requested one, do you mean AFTER all the neuropsych testing, etc? Or were you able to request one from your family physician, and avoid the other testing? I think the insurance companies should not be able to deny a test, especially if doing so leads to an AD diagnosis. And they called AD a mental health issue - wow, that's creative. Maybe I could play let's make a deal with Blue Cross - I'll pay for it, if it comes back negative...they pay if it leads to an AD diagnosis...sigh, I suppose they wouldn't go along with that. But, I'm still thinking it would be worth almost anything to go straight to a scan (diagnosis) and skip everything in between.
We did have appts with neurologist, but the psychologist reported that she had a histrionic personality disorder and transference. She could not do the mmse tests because she did not have her reading glasses with her, so he said she showed lack of effort...the neurologist wanted to fuse her vertebrae in her neck to inprove blood flow to her head and cure her alzheimers.....after getting no results, I asked her doctor for the pet scan....when we went to the hospital to do a pet scan of the head, their instructions were to do a full body scan...I refused and would only allow the pet scan....Because of the confusion between dr and hospital, the wrong diagnosis codes were used and hence Blue cross declined coverage.... I felt that all the neuropsyc testing was useless...it was very obvious to me that she could not do them and that the results might not be accurate...I personally believe that most psychologists and psychiatrists are a bit nuts themselves....(takes one to know one)... SO yes, you can skip all the testing, and ask for a PET scan....but you might have to pay for it.....unless the doctor is willing to write that he is checking for something else in the brain...such as athlete's foot, cancer, etc....I personally think the Pet scan is the way to go...much more accurate than some bozo asking questions and trying to score on a test....
So, in the eyes of the insurance companies, AD is not a real disease - or at least not a disease deserving of a diagnosis. They're the ones that should be taking a psych test!
Thanks for the info, Frank.
This is all new to me, but in the years of people trekking the halls of congress, has anyone thought to push for a law designating AD as a disease deserving of a diagnosis via a PET scan? I hate to be a cynic, but is it possible the medical establishment wants to force people into the research environment? As awful as this disease is, perhaps they would not get enough volunteers, post diagnosis, if patients were able to bypass the research facilities and simply get a diagnosis from a PIB Pet Scan.
First, let me say that each of us has a different insurance policy, unless we are only covered by Medicare. Each individual policy covers different things. No two policies are alike. My insurance policy covered the MRI and PET scan and it was for determination of AD. I know several others whose policies cover it as well. The PET scan sometimes requires pre-approval, and when given, that better be the same code that is submitted for payment or you will have problems. The PET scan for AD is not considered new technology in most policies. I have blue cross too. And my policy also covers respite care in the Hospice Hospital. So, read your policy and see what coverage you do have. Have your doctor call and get pre-approval and you may find that your policy will cover it.
Mary22033, speaking as a doctor I can assure you that the medical establishment does not want to force people into the research environment. We are as frustrated as anyone over the various rules of the insurance companies and medicare. One of my reasons for retiring was that I was sick and tired of the insurance companies and government telling me how to treat my patients. That's why I love working in the free clinic - no insurance or government to deal with. I wonder what would happen if a doctor used Phranque's idea of saying we are doing a brain scan to look for athletes foot. With some insurance companies it might get through. Years ago, at the start of medicaid, I left the diagnosis line blank. The form was returned for the diagnosis so I put in "NOYDB" (none of your darn business). The claim was paid by return mail. That wouldn't work now since we have to use number codes rather than words. If the diagnosis does not have a code number we have to chose another diagnosis.
I found an update to the PIB PET scan. They have completed a successful phase II trial of a new derivative of the PIB coumpound - 18F-flutemetamol PET. I guess they are trying to overcome clinical shortcomings of the PIB-11C version. Phase III trials are recruiting now. I guess my DH is just a little ahead of the curve on this technology - too bad!
"Sensitivity and specificity with clinical diagnosis as SOT (Alzheimers' Disease vs Healthy Control) was 92.6 percent and 96 percent, respectively. The correlation coefficient between 18F flutemetamol SUVRcomp and 11C-PIB SUVRcomp was 0.94."
"The viability of the agent, 18F-flutemetamol PET, could augment the impact of beta amyloid imaging on research and clinical practice since its use does not require an on-site cyclotron."
for the article go here: http://www.itnonline.net/node/36623/3
This will be wonderful - I guess a few years down the road...
I think the only PET scan available to us right now (outside of a research study), even if I pay myself, is is the FDG PET scan.
And I definitely would have liked Marsh as my doctor! I like to mess with people when I fill out medical forms, too. For occupation I write "Domestic Goddess." When the form asks if there's a possiblity I am pregnant I put "I'd be on a high bridge - not here."
Mary- I like your attitude....When I fill out paperwork, I also fill out stupid things. Like occupation- preoccupied under sex, I usually answer sure, but call me first. and sometimes I sign the forms with some popular name....such as Clark Kent, Dr. Seuss, James Bond.....and no one ever seems to notice....
Foster and I were returning from a trip to Europe and I presented my passport to the man. Rude, always rude..right? I handed it to him and smiled. Suddenly, I realized I had Foster's passport and he had mine. The guy checked the back pages of the passport..stamped hard, two or three times on two pages..scowled at me and handed it back. Didn't say a word about it was a MAN's picture on the passport. I should have quickly handed Foster's passport to him, to avoid problems, but I was just tacky enough (and tired enough) to wait and watch. He did the same thing with Foster. Looked at the first page, then checked the stamps in the back...whomp whomp as he slammed his stamper onto the passport and guestured ffor Foster to move through. By now I had bad bad giggles, and Foster had no idea why. (He hadn't noticed our passports were switched). That was one of highlights of the entire trip! Those immigration people at airports are so rude!
I contacted the University of Pittsburgh - Alzheimer Disease Research Center and asked "I was just wondering whether the PIB Pet scan would ever be available as a tool for a family physician to use, the way they use CAT scans today. If so, is that day coming soon or is still years or decades away?" Here is their response, FYI: "PIB testing is still in clinical trials. Participants for the trials are selected from our registry of people who come to the Alzheimer Diaease Research Center her in Pittsburgh for evaluation. Also is important to understand that since this is a research study results of PIB scanning are not given to the subjects who participate in the studies. As far as when PIB will be available as a diagnostic test for the public that is hard to say. We are still in the experimental phases, then the study data has to be analyzed, papers published and FDA approval sought. My guess is that it is several years away."
Now I have the answer to my original question: Who decides? Answer: the FDA.
Good news: Lilly Alzheimer's imaging agent to get priority FDA review: http://www.bloomberg.com/news/2010-12-21/lilly-alzheimer-s-imaging-agent-to-get-fda-review.html
Now, if it gets approved within 6 months, do you suppose the government is going to require patients to take the extensive neuropsych testing, before they can have a scan? Either way, won't it be wonderful for a PCP to be able to order this beta-amyloid scan to check for Alzheimer's, just like they order a CAT scan looking for a brain tumor?
Hopefully with all the recent news of an Alzheimer's sunami getting ready to strike with aging baby boomers, the FDA will see the need for this and approve it pronto...
description of imaging technique: http://www.sciencedaily.com/releases/2010/06/100624214318.htm
mary22033--Yes, if a PCP could order the scan it would be a great step forward in diagnosing the disease.
I'd like to address something in your original post--choosing between the family physician and a memory clinic. Our experience has been that my husband was dx with EOAD at such a clinic, 5 1/2 years ago. At that time, he was not referred anywhere else for neuropsych testing, nor was he subjected to excessive questioning by the neuro--pretty much the MMSE. (He must have had a pretty clear-cut case of EOAD and has a family history of it.) Of course, he also had a brain scan (MRI) to rule out physical causes. Anyway, the reason I'm glad it was done this way vs. a family physician is that over the years, his neuro has been able to very successfully manage problem behaviors using the various psych drugs. I know for a fact that our family physician would never have been as successful, since she just doesn't specialize in dementia care. (And let's face it, there is still some trial and error even with a specialist.)
If you haven't proceed further than your original post, perhaps you should investigate other memory clinics in your area who may not require the referral for neuropsych testing. I agree that the testing may be overkill and may simply not add anything beneficial to your husband's course of treatment.
Another potential benefit of being seen at a memory clinic is that they may attempt to provide more support for the caregiver and family than a general practice can. Just my opinion--AD--and particularly EOAD--can be a tremendously challenging disease to manage and I want to have all the ammunition in my corner that I can muster!
Thanks for the advice Marilynn. Since my original post, my husband has been to a neurologist, has taken the neuropsych test, and was diagnosed with Mild Cognitive Impairment, Multiple Domain Subtype. The report did recommend further imaging tests, but so far we have not done that because we were unhappy with the neurologist. Our next stop is going to be the Georgetown Memory Disorder Clinic; I am waiting until after the holidays to encourage my DH to make the appointment. It sure would be nice to be able to have the beta-amyloid imaging scan when we do go.
I was thinking of maybe testifying at the FDA advisory commission review on Jan 20, and putting a human face on the issue. I am so tired of reading things like this – “But the new diagnostic tests are leading to a moral dilemma. Since there is no treatment for Alzheimer’s, is it a good thing to tell people, years earlier, that they have this progressive degenerative brain disease or have a good chance of getting it?” see here: http://www.nytimes.com/2010/12/18/health/18moral.html?partner=rss&emc=rss
How is there a moral dilemma? The knowledge does not lose value simply because the doctor cannot follow-up with a pill. Families need to know why Daddy is suddenly mean and nasty. Why daddy is zoning out. Why daddy can’t follow a conversation. Why daddy keeps buying ketchup when there is a shelf full of it in the pantry. And Daddy needs to know why everyone is claiming he’s having issues, when he doesn’t notice anything different himself. Families need to take the necessary steps to protect their finances; to plan for a much different future where the bread winner is no longer working. Families need to know that there will come a point when daddy should not be driving. Daddy deserves to know, so that he can make that trip to the Superbowl that he has always dreamed about. He needs to know that he should do it this year, because he may not be able to do it 5 years from now.
There is no moral dilemma – families deserve to know – they need to know.
I agree with you on this issue, Mary. I have heard it batted around in the medical community for a number of years (haven't read the NYT article yet). If you can testify at the FDA review, I say go for it. I testified before a Senate Subcommittee several years ago regarding the Alzheimer's Breakthrough Act, which was requesting money for AD research (to date, as far as I know, it still hasn't passed). It was an intimidating experience, but I'm glad I did it.
Keep looking for a neuro that you both can have a rapport with. For me, accessibility has been a key element--I email my concerns to my husband's doctor and he gets back to me in a flash.
I think this was a positive review! The FDA advisory panel would not approve the imaging test until the company establishes a training program for image readers, and they also wanted them to go back and rehash data from one study. These sound like very small hurdles.
I am excited that now MCI patients will have available a scan that will say "yes" you have amyloid deposits, or "no" you do not. A BIG STEP FORWARD in early diagnosis! The panel specifically sited the utility with MCI patients, because studies showed strong data that MCI patients who do not show amyloid plaques on these images- do not go on to Alzheimer's. Likewise, MCI patients who DO show amyloid plaques on these images - do go on to Alzheimer's.
It would be so helpful to be able to have one of these tests for my DH, so that we could know and plan and adjust....
I was waiting for news releases to verify my take on the meeting and here are 2 - lol!
Here is Lilly's press release: INDIANAPOLIS and PHILADELPHIA, Jan. 20, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee decided today that it could not recommend approval of Amyvid™ (florbetapir) at this time based on the currently available data (13-3); but, voted unanimously (16-0) to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans. The Committee supported that efficacy was established and there were no significant safety concerns raised.
Amyvid is a molecular imaging tool under investigation for the detection of beta-amyloid plaque in the brain. The Committee stated that a negative scan would be clinically useful in indicating that Alzheimer's pathology is unlikely to be the cause of a patient's cognitive decline.
Lilly acquired Avid Radiopharmaceuticals, Inc. in December 2010. Amyvid is Avid's lead candidate and was the first beta-amyloid imaging compound to enter multi-center, investigational new drug (IND) clinical studies in the United States. Amyvid was recently assigned priority review designation by the FDA.
"We appreciate the careful and thoughtful review of our data today by the Committee," said Daniel M. Skovronsky, M.D., Ph.D., CEO, Avid Radiopharmaceuticals, Inc. "We are encouraged that they recommended a clear path toward approval."
The FDA will consider the panel's recommendation in its review of Amyvid. The FDA takes the advice of its Advisory Committees into consideration when reviewing investigational drugs, but is not bound by their recommendations.
About Amyvid
Amyvid is an imaging tool indicated for Positron Emission Tomography (PET) imaging of beta-amyloid plaque in the brain. It's being investigated for the potential use in ruling out Alzheimer's disease. In addition to the pivotal Phase III "Image-to-Autopsy" study, other clinical studies are also being conducted in the E.U., North and South America, Australia and Asia.