FDA to consider Alzheimer's test for living patients
January 18th, 2011
04:56 PM ET

FDA to consider Alzheimer's test for living patients

One of the many frustrations of Alzheimer’s disease is the difficulty in pinpointing just who has it. According to published research, as many as one in five people told they have Alzheimer’s are mislabeled. A definitive diagnosis can  be made only after death, by an autopsy that reveals a distinctive buildup – known as amyloid plaques – in the patient’s brain. This week, however, the FDA will consider a new diagnostic test that may be able to identify those plaques through PET scans – a type of brain scan – on living patients.

In a small study run by Avid Radiopharmaceuticals and made public Tuesday in the Journal of the American Medical Association , PET scans identified the telltale plaques in 97 % of patients who actually had them, as determined by a subsequent autopsy. The 35 patients in this part of the study were terminally ill, and agreed to both a brain scan and an autopsy.

The researchers also performed PET scans on presumably healthy people to try to ensure that the test could tell the difference. It could. Of 74 young and healthy people tested, none had scans indicating Alzheimer’s.

Before performing a PET scan, a doctor or technician injects the patient with a radioactive dye that can be detected by the imaging equipment. The particular dye used in this test was developed by Avid and is known as Florbetapir F 18. Chief Executive Officer Dr. Daniel Skovronsky says Florbetapir F 18 binds tightly to the amyloid proteins – making them visible to the scanner – but doesn’t bind to other tissue.

According to Skovronsky, diagnosis of Alzheimer’s still depends on a clinician who can evaluate a patient’s overall condition, but he says the test with Florbetapir could be especially useful as a tool to rule out Alzheimer’s. In that scenario, a patient who shows symptoms of dementia would be given a PET scan; a negative result would push her physician to consider other conditions.

A second paper in JAMA suggests that a simple, low-cost blood test can tell whether a person is at risk for cognitive decline, which is a precursor to Alzheimer’s.

During a span of 10 years, researchers checked the blood of 997 elderly people in Memphis, Tennessee and Pittsburgh, Pennsylvania, testing for two types of proteins that are associated with Alzheimer’s. They re-tested each person at 1-year, 3-year, 5-year, 8-year and 10-year intervals. Patients with lower levels were significantly more likely to suffer cognitive decline over time.

Researchers also found that patients with more “cognitive reserve” while healthy, are less likely to decline. “Cognitive reserve” is measured in various ways – for example, by years of school attended, or performance on intelligence tests.  The researchers say it may be that people with higher intelligence or more education are able to better compensate for functions lost to early cognitive decline.

soundoff (53 Responses)
  1. cabo wabo

    my mom has alzheimers. what does it matter if it can be clincally detected? you can tell by just talking to her. how about a cure?

    January 18, 2011 at 22:44 | Report abuse | Reply
    • Dan

      My grandmother passed from this. It runs in our family.

      Sadly, there's no money in a cure. Big Pharm makes way too much money on expensive stop gap medications to ever commit to a cure. It's the same way for HIV. Our healthcare system has been run by shareholders and board members for decades now.

      January 19, 2011 at 00:51 | Report abuse |
    • Jesus

      Big Pharma discovered long ago that there's no money in a cure. They make huge bucks treating the illness for many months or years. I truly believe that if somebody found a cure, they would some way never be allowed to bring it to market OR it would watered down to take effect after years of dosing..

      January 19, 2011 at 03:54 | Report abuse |
    • switbo

      First – let me offer my sympathy. My father also has it, and I know how difficult it is to watch this happen to a loved one. Secondly, the benefit of a reliable test is that there are medications that can slow the decline and the earlier in the disease they are taken, the more effective they are. So being able to test for it could ensure that someone gets medication sooner.

      That said, we still need a cure.

      Best wishes.

      January 19, 2011 at 08:40 | Report abuse |
    • HC21

      I'm sorry for all your family is going through with this. We watched my grandma suffer from Alzheimers in the late 90s to the early 2000s.

      If 1/5 are misdiagnosed as having it when they really have something that just seems similar, then those people are not getting the correct treatment for whatever they really have. This scan could lead to further findings about the actual disease and also prevent a lot of misdiagnoses.

      January 19, 2011 at 09:46 | Report abuse |
    • eli lilly

      well, Eli Lilly has to make billions of dollars by diagnosing all of us as Alzheimers patients. Doctors love these imaging agents because they cab submit $10,000 imaging bill to insurance companies and make huge profits. I understand science, but we have to be careful with such diagnosis agents.

      January 19, 2011 at 09:56 | Report abuse |
    • Linda

      I understand, my grandmother is in advanced stages right now.
      switbo.. the meds may slow things down, but the side effects are often severe on patients. She was on them for awhile, but went off of them because of it. It only delays the inevitable. While many diseases you want to do your best to fight, with no cure or real help for this disease it is one case where you almost want a quick death.

      January 19, 2011 at 10:13 | Report abuse |
    • It's science

      You do realize that if it can be detected with certainty in a living patient that it will be a lot easier to treat, right? You can't cure anyone if you don't know for sure that they have something to cure.

      January 19, 2011 at 10:20 | Report abuse |
    • l dean

      I can tell that you are suffering, because your question reeks of sarcasm. It MATTERS, because there are many types and causes of dementia – many of which are treatable and curable. Dementia is sometimes a side effect of medications. Once the medication is discontinued, the dementia stops. Some dementia associated with other diseases are also treatable. That's why it's extraordinarily important. You absolutely cannot diagnose Alzheimer's by "talking to a person." My mother died from Alzheimer's, and my father took care of her for 10 years. Now, he thinks he has it, but refuses to discuss it with his doctor. I think he is suffering from Transient Global Amnesia from taking Zocor (which can be treated by a pill), but until today, he knows there is no positive diagnosis for Alzheimer's, so I assume he prefers to just go along thinking it is something else and not knowing for sure. Preparation and planning helps when there is an early diagnosis – labeling cabinets etc. that can help an Alzheimer's sufferer extend their independence; besides the fact that there are meds to slow the process if caught early – and how wonderful would it be to slow it enough that your parent is still alive when a cure is found. Know too that via, The Alzheimer's Association, there is relief for you as a caretaker – call them or contact them via their web site. You don't have to go through this alone. I understand your anger – it makes me angry too; but, wonderful things are happening in research for a cure. Also, reach out to support groups in your community for caretakers. I think from your words that you need some relief. Best to you. lindsey in NC

      January 19, 2011 at 12:19 | Report abuse |
    • Wayne

      I agree with Dan. We won't see a cure until the pharmas have milked every penny out of treatment. I've had two aunts who died from the disease. I often thought it was harder on family and friends that the patient. But I say there's hardly anything more heartbreaking to watch than a wife who doesn't recognize her husband of 60 years.

      January 19, 2011 at 12:50 | Report abuse |
  2. Philip

    They can't cure the common cold they say. But they will cure aids and cancer if enough money is provided to them they say. They say a lot.

    January 19, 2011 at 02:30 | Report abuse | Reply
    • It's science

      Ever stopped to research why it's impossible to cure the common cold? Any idea why it might actually be easier to cure something like AIDS? How about you crack a book?

      January 19, 2011 at 10:19 | Report abuse |
  3. functional Health

    Can be cured with.
    Ergothioneine, glutathione, taurine, alpha lipoic acid and MSM. All the best and don't trust pharmacy

    January 19, 2011 at 05:55 | Report abuse | Reply
    • M

      What is this information based upon? Have you ever been a care giver to a dementia or alzheimer's patient??

      January 19, 2011 at 08:36 | Report abuse |
    • What?

      So we should be filling old people with energy drinks and rubbing them down with skin cream to keep them from getting Alzheimer's?

      January 19, 2011 at 10:35 | Report abuse |
  4. Amelia

    My mother in law has this horrid sisease. It is sad to see her deteriorate while you feel helpless to asist her. I have found some peace in articles written on the health channels at http://www.YourCity.MD which have helped a little and give some hope. My city portal is Cincinnati and the articles are available free at this link: http://www.cincinnati.md/cincinnati-oh/relief-center/Alzheimer's
    I hope this helps some of you as well. I also believe, the pharmacuetical companies could surely help these people if they wanted.

    January 19, 2011 at 07:25 | Report abuse | Reply
  5. Lynn

    A few years ago my mother was suspected of having Alzheimer's. A neurologist performed numerous tests, including a PET scan. Not part of this study, but used a similar injectable dye. The PET scan came back negative for Alzheimer's. So the neurologist explored other causes of her memory loss and disorientation. Turned out she has a type of chemical dementia where the brain chemicals are causing a communication breakdown between neurons. Mom was put on a mild anti-depressant and within a couple of months she showed great improvement. Now at age 83, my mother has occassional memory laspes, but no worse than I do at age 50. So while this test is not a cure, it can be a major diagnostic tool. If the scan shows Alzheimer's, treatment and a care plan can be developed earlier. If it is negative, other possiblities can be explored. Thank goodness this was done for my mother. It has made all the difference in the world.

    January 19, 2011 at 08:38 | Report abuse | Reply
    • Robin

      Thankyou for your post.
      Could your reply as to what the name of the test is that your doctor ran for the chemicla demential?
      The Alzheimer's diagnosis also runs in my father's side of the family. I have never believed the diagnosis was correct. Could you reply as to what the name of the test is that your doctor ran for the chemical dementia? My father held two master degrees and was close to his Doctorate when he started to decline. He spent his last years in a Alzheimers unit at a Veterans home. There were lawyers, doctors, CEO'S of large corporations and a former Governor of the the State. I don't believe that the last paragraph of the article is always true. Most of the patients at the home were highly educated and stricken in their late 50's and early 60's.

      January 19, 2011 at 09:11 | Report abuse |
  6. Reality Cehck

    Early detection of Alzheimers may sound good but the larger question is of what value are these tests if there is no cure or even treatment for Alzheimer's disease. In fact, many peoples lives have been ruined by so called early detection of the disease even though the rate of decline of the patient varies. Typically, a patient gets diagnosed and it destroys their mental outlook as they believe that everyday is another day closer to dementia. However, you can be diagnosed and not have symptoms for years ... with no cure, no treatment .. what good is early detection. We ought to save the testing money and apply it to the care every patient will need when they reach stage 3 which is dementia and extreme loss of mobility.

    January 19, 2011 at 09:11 | Report abuse | Reply
    • Thatguy371

      Actually, the sooner a person is diagnosed and gets treatment, and stays on it, the longer they can ward off the disease. My father was diagnosed in '93, and passed away in '00. If I would've known what I know now, and gotten him tested earlier, and with the medication available now, he would've probably lived the rest of his years Alzheimers free.

      January 19, 2011 at 09:42 | Report abuse |
    • not demented yet

      What good is early detection? I have a relative who was diagnosed very early in the disease. That individual has made distinct choices in the intervening years which they would not have made otherwise. Knowing that the AD freight train is coming down the tracks at you seems to crystallize thoughts. If you have memories you want to persist for your progeny, you know you'd best record them lest they be lost.

      As far as others go in looking for conspiracy theories about "real treatment does not generate enough revenue" - if and AD cure could be found, society would gladly pay for it. On the other hand, you will die of something - if we improve cardiovascular health, reduce cancer risk, etc all we are doing is moving the ultimate cause of death.

      January 19, 2011 at 11:56 | Report abuse |
  7. Thatguy371

    Good to hear progress is being made, hopefully a cure is within reach. I do tend to agree with those who say the powers that be will never come up with a cure as it's not good economics for the pharma etc.... but I think that argument can only go so far. The baby boomers are reaching retirement age, and a group that large will cause an epidemic of Alzheimers... and this nation isn't capable of caring for that many people with the disease. For those of you who are care givers, having been one myself along with my Mom caring for Dad, I can tell you it is very important to get support, and do not overdo it. Join an Alzheimers support group, and work things out so you don't have to care for your loved one 24/7. You cannot do it alone. And for all of you who are considering the PET test... do it. The sooner the better. Then, if you do have Alzheimers, the medication you then take will slow the illness significantly.

    January 19, 2011 at 09:35 | Report abuse | Reply
    • not demented yet

      One point in the economics of treating dementia is this: you will die of something. If drugs to keep individuals engaged in normal "activities of daily living" for long enough that they likely die of something else BEFORE going into the nursing home from AD, then it's an economic win. You will die; the economically optimal solution is that you die from something that has an inexpensive path to death. The AD path to death is long slow and expensive, even a partially effective treatment drug has economic implications. Yes, I know this will set the politically nutty folks all of talking about death panels etc, and I'm not advocating that. Just pointing out that there are economic incentives to keep AD patients out of nursing homes as long as possible.

      January 19, 2011 at 12:03 | Report abuse |
  8. Missy

    I'm glad that they finally have a test like this. My dad is displaying symptoms of early alzheimers so if this test could pin point if it is in fact alzheimers or some other health issue would be a relief....

    January 19, 2011 at 10:22 | Report abuse | Reply
  9. Rod Venger

    Question: How is a patient who is terminally ill with Alzheimers competent enough to give informed consent for the study? Or was it their caretakers that did so? Something seems amiss.

    January 19, 2011 at 10:35 | Report abuse | Reply
  10. g

    send to cat.

    January 19, 2011 at 10:51 | Report abuse | Reply
  11. susan

    I work with residents who have this dreaded disease. It is so sad to see their decline on a daily bases... My advise if you can afford keep them at home where their memories are closest to their soul... There are also agencies in every state that provide home health care assistance....my love to all families living with this daily experience...My mother was diagnosed last summer....we have our good days and a few bad days...

    January 19, 2011 at 10:52 | Report abuse | Reply
  12. hnic

    current medications for AD do not slow down the progression of the disease, they treat the symptoms.
    that said, this will be a major step forward for diagnosing AD, which as of now is only a confirmed diagnosis upon autopsy.

    January 19, 2011 at 11:13 | Report abuse | Reply
  13. T&L

    Has anyone checked out a company called Curaxis Pharma? They have a new drug out called Mymrite... They are in there second or third phase of testing and all signs point to a good medication for the illness. We will have to wait and see what happens with this one... It actually halts the progression of Alzheimers and some types of cancer...

    January 19, 2011 at 11:30 | Report abuse | Reply
  14. Jeff R

    I recently had an MRI at VA hospital because of memory problems. It didn't show anything unusual. I want to know if I am getting Alz so I can plan things out. I want to make sure I am not around to cause my family grief for years. One has to make plans while one is capable of acting on them.

    January 19, 2011 at 11:32 | Report abuse | Reply
    • Amy

      Why do you need to know if you have Alzheimer's to make those plans? Do it anyway, take control of your outcome and draft a living will and save everyone the heartache of making painful decisions regardless of what your future may hold.

      January 19, 2011 at 13:34 | Report abuse |
  15. Sandy

    My mother who is 89 and has dementia was taking Aricept which was prescribed by one of her doctors. When we moved her to another to live with us after my father passed away, another doctor (after evaluating her and the drugs she was taking) told us that Aricept was so useless and expensive it had been banned in Great Britain (he's from there). The only thing it did was give her muscle cramps so bad, she couldn't sleep at night so she was taken off of it. I wouldn't recommend it for anyone with either dementia or Alzheimers.

    January 19, 2011 at 11:36 | Report abuse | Reply
  16. Walter

    Unlike others here, I actually am grateful for Big Pharma. My mother has greatly benefitted from Aricept; and though it's not a cure, it's great for my kids to be able to still have their gramma around – both physically and mentally. I also disagree that the drug companies won't provide a cure. I think that any "cure" will involve taking medication for the rest of one's life; so even my cynical side says they would provide it since they would have an unending supply of revenue.

    January 19, 2011 at 11:42 | Report abuse | Reply
  17. GranddaughterOfAlzheimer's

    As the granddaughter of a current alzheimer's patient, I hope and pray this test is approved and people can get earlier diagnosis. The medications currently available don't cure alzheimer's, they don't prevent it, they only delay its severity. They work best when started very early. Because there is no definitive test, patients currently have to undergo a barrage of tests that are not always effective. We pushed for medication for my grandfather for 5 years before he tested poorly enough to qualify. His decline in those 5 years was astonishing, but since starting the medication, he has shown even more drastic decline. It is heartbreaking to see this man, my hero, a veteran of WWII, not even know who his wife and children are. To him, I am his sister in her early 20's (before she was married). Some in my family find it all amusing, that grandpa is just "forgetful." He doesn't find it funny – he knows what is happening and it frustrates and embarasses him. In his more lucid moments, he has expressed to me his desire to "end it all." Sadly, at this point, I am almost able to agree with him ... death is better than what is becoming of him. And my grandmother, stubborn as she is, is his primary caregiver at this point – to see the effect it has had on her is even more devastating. Early detection is KEY to improving the lives of patients – and their families!!!! Time is the most precious gift we can be given – if this test can give us even three or four more good years before this devastating disease takes our loved ones away from us (mentally, if not physically), then it should be approved and, in my opinion, required. It should be available to anyone with a family history of Alzheimer's.

    January 19, 2011 at 11:55 | Report abuse | Reply
  18. Philip

    Alzheimer's disease is Mad Cow disease in disguise. Spend a couple hundred hours over the next ten years investigating this for yourself, and then you will know the truth. Or you can continue to believe what you are told to believe. The choice is yours.

    January 19, 2011 at 12:15 | Report abuse | Reply
  19. Charley1

    Alzheimers sucks really bad....and so does big pharma

    January 19, 2011 at 12:34 | Report abuse | Reply
  20. Philip

    You won't see a cure because there isn't one. Old age combined with tainted red meat is Alzheimers disease. There is no cure for old age, and you will continue to eat tainted red meat. Any looking for a cure is done by those who make their living looking for cures. Even if they found "the cure", their multi-billion dollar industry would die. Who would allow that to happen.

    January 19, 2011 at 12:58 | Report abuse | Reply
  21. Jim

    It amazes me that many people truly believe researchers / pharma are conspiring to prevent the cure of disease. It would behoove you to study and understand the etiology & pathogenesis of these diseases before throwing out such accusations.

    Reassess your views when you have an understanding of the complexity of these matters.

    January 19, 2011 at 13:32 | Report abuse | Reply
  22. bob

    While I agree that earlier diagnosis could allow for better treatment and or prevention it will also guarantee that we all end up with a pre-existing condition and then will not be able to receive said treatment anyway. Not exactly heart warming.

    January 19, 2011 at 13:36 | Report abuse | Reply
  23. bluewhale

    re: Question: How is a patient who is terminally ill with Alzheimers competent enough to give informed consent for the study? Or was it their caretakers that did so? Something seems amiss.

    Those of us who saw it coming early enough got Power of Attorney signed, became Representative Payees, got DNR's (Do Not Resuscitate) signed, and bankrupted our loved one. All had to wait for lucid moments. So we're the ones giving informed consent. I promise all, if such a test became available such that I could take it, I'd pay for it myself in a heartbeat. Every memory lapse I have, I internally cringe that it may be a sign of what has devastated my mother.

    January 19, 2011 at 13:40 | Report abuse | Reply
  24. karek40

    Well if I had it and it was found in its early stages I would certainly want to know. Early knowledge could provide time for me to get affairs in order that otherwise I might put off. It could provide you a measure of control over your estate when you are mentally incompentent to do so.

    January 19, 2011 at 13:55 | Report abuse | Reply
  25. getty46360

    I think it's good to hear about any kind of progress being made when it comes to this terrible disease, my grandmother, uncle and now my dad has it so it definately runs on my fathers side. But I'm 34 years old and when I find myself about to put something in the microwave that belongs in the fridge it kinda makes me think! So this is hope at least! Hopefully a cure will come one day along with a cure for cancer and hiv.

    January 19, 2011 at 14:22 | Report abuse | Reply
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    Yeah, and General Motors will find a cure for car and truck.

    January 19, 2011 at 16:35 | Report abuse | Reply
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