Monday, April 29

F18 Scans Diagnose Dementia Better


At $3,000 per scan, are F18 Scans worth it? They let doctors see plaque in the brain, the main suspect behind Alzheimer's. They show doctors if, where and how much plaque there is. They can sharpen an Alzheimer's diagnosis or rule it out completely. Learn how F18 Scans improve care and diagnosis.

INDIANAPOLIS -- Eli Lilly released important data showing that F18 beta-amyloid imaging was associated with better diagnosis and management of patients with dementia.

100 Types of Dementia

There are over 100 types of dementia. Some are curable, some demand different treatments than others. The differences in treatment can be critical.

The most common type of dementia is Alzheimer's disease. It is so common that it is common for doctors to diagnose a patient with Alzheimer's when they really have a different type of dementia. This can lead to ineffective or even dangerous treatments. Furthermore, even when a person has Alzheimer's, it is challenging to treat it. Doctors usually base the medications they prescribe, as well as recommended treatments, on a somewhat subjective judgement call referred to as a "clinical diagnosis".

With new F18 scanning technologies, doctors can actually "see" how much Alzheimer's plaque is in a person's brain, if any. They now have an objective tool to help them dramatically sharpen their diagnosis.

To see an invterview of a patient who benefitted from an F18 Scan after he was diagnosed with dementia, watch the video,
"F18 Alzheimer's Scan Delivers Better Prescriptions & Fewer Tests".

In this latest study from Ely Lilly, change in management  was observed in both patients who met and did not meet the Appropriate Use Criteria (AUC), which were developed by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association to provide guidance on which patients are most appropriate for imaging and how best to use the results. These data were presented at the Alzheimer's Association International Conference (AAIC) by Andrew Siderowf, M.D., MSCE, medical director, Avid Radiopharmaceuticals, a subsidiary of Lilly.

Fine-Tuning Alzheimer's Diagnosis

"This study included patients in which there was diagnostic uncertainty by the treating physician and found that changes in diagnosis and management of Alzheimer's disease did not vary between patients depending on whether they met the Appropriate Use Criteria (AUC) or not. In addition, analysis of beta-amyloid scans conducted post-diagnosis indicated that many patients being treated with medications may have potentially been misdiagnosed and inappropriately treated," said Dr. Siderowf. "While we support the development of the Appropriate Use Criteria, one of the clearest insights resulting from these data is that we need to continue to fine tune our understanding of the appropriate use of these tools and their utility for patients facing a diagnosis of Alzheimer's disease."

Is the Alzheimer's Diagnosis 100% Certain?

The objective of the study was to evaluate which patients are most likely to receive different care if they had an amyloid PET scan as part of their diagnostic work-up. In particular, the study evaluated if patients who met the working definition of the AUC would be more affected than those who did not. The AUC guidelines propose that patients who are being evaluated for dementia with atypical presentations, younger patients, and patients with unexplained mild cognitive impairment, are most appropriate for amyloid PET imaging. For the patient to be included in the study, Alzheimer's disease had to be under consideration and the treating physician had to have uncertainty regarding the diagnosis.

Scans Change Alzheimer's Treatment 3 Out of 4 Times

To see an interview of a patient who actually used an F18 Scan after he was diagnosed with dementia, watch the video:
F18 Alzheimers Scan Delivers Better Prescriptions & Fewer Tests .
Results showed that 59 percent of subjects met the working definition of AUC. Forty-seven percent of the AUC-like cases were amyloid positive compared to 62 percent of non-AUC cases. Diagnosis changed after PET scan for 58 percent of AUC cases versus 45 percent of non-AUC cases (p=0.10). The proportion of patients with change in management plan was high for both AUC (88 percent) and non-AUC (77 percent) cases. In particular, the use of Alzheimer's disease medications including cholinesterase inhibitors, or memantine, declined after a negative florbetapir F 18 scan by 20 percent (from 26/54 to 15/54 cases; p=0.002) in AUC cases and by 33 percent (from 17/27 to 8/27 cases; p=0.004) in non-AUC cases. Diagnoses for non-AUC cases in which Alzheimer's disease medications were withdrawn after a negative scan included prodromal Alzheimer's disease/mild cognitive impairment due to Alzheimer's disease (n=8), or mild cognitive impairment of uncertain etiology (n=1). This study found that patients with an uncertain diagnosis, but who are not otherwise explicitly captured by AUC, may be reasonable candidates for amyloid imaging.

1 in 5 Misdiagnosed with Alzheimer's

"Alzheimer's disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. In fact, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's disease during life do not exhibit Alzheimer's disease pathology upon autopsy[1],[2]," said Dr. Siderowf. "These results reinforce how knowledge of the presence or absence of amyloid pathology can substantially affect both diagnosis and management in these patients being evaluated for Alzheimer's disease or other possible causes of cognitive decline."


Study Methods 
The impact of amyloid PET on actual patient care was examined in a previous study.[3]

In the prior study, performed at 19 clinical sites, treating physicians provided a provisional diagnosis and management plan prior to receiving results of amyloid PET imaging with florbetapir F 18. Participants' medical records for the three months immediately after imaging were abstracted to capture their actual diagnosis and management. For the current study, participants were classified as meeting an operational definition of AUC-like or not, based on pre-scan diagnosis and demographic features. 

About Florbetapir F 18 Injection[6] 
Florbetapir F 18 is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative florbetapir F 18 scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive florbetapir F 18 scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Florbetapir F 18 is an adjunct to other diagnostic evaluations.

Limitations of Use:
  • A positive florbetapir F 18 scan does not establish a diagnosis of AD or other cognitive disorder
  • Safety and effectiveness of florbetapir F 18 have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring responses to therapies

Risk for Image Misinterpretation and Other Errors
  • Errors may occur in the florbetapir F 18 estimation of brain neuritic plaque density during image interpretation
  • Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of florbetapir F 18 images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the florbetapir F 18 scan as well as motion artifacts that distort the image
  • Florbetapir F 18 scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future
Radiation Risk
  • Florbetapir F 18, similar to other radiopharmaceuticals, contributes to a patient's overall long‐term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure
  • The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)
For more information about florbetapir F 18, please see the Prescribing Information athttp://pi.lilly.com/us/amyviduspi.pdf.

About Eli Lilly and Company 
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels

Amyvid™ is a trademark of Eli Lilly and Company.

[1] Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001;57(2):226–234. 
[2] Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of Alzheimer's disease in a community-based case series. J Am Geriatr Soc. 1999;47(5):564–569. 
[3] Grundman M, Pontecorvo MJ, Salloway SP, et al. Potential impact of amyloid imaging on diagnosis and intended management in patients with progressive cognitive decline. Alzheimer Dis Assoc Disord. 2013 Jan;27(1):4-15. 
[4] Alzheimer's Association. 2014 Alzheimer's Disease Facts and Figures.http://www.alz.org/downloads/facts_figures_2014.pdf. Accessed on June 4, 2014. 
[5] Alzheimer's Disease International. Policy Brief for Heads of Government: The Global Impact of Dementia 2013 - 2050. http://www.alz.co.uk/research/GlobalImpactDementia2013.pdf. Published December 2013. Accessed onJune 4, 2014. 
[6] Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012. 

Eli Lilly and Company

Comment or Share:

  1. Again a good deal to pharma companies but a bad deal to patients.
    How can we trust in a very expensive test ($3000) that intend to diagnosis AD , and that in fact have a chance of 55% of error? And in this case , Medicare it is absolutely right to do NOT cover a so inaccurated and not reliable tests , as that of amyloid tracers (biomarkers),exactly because it can leads to a lot of patients to be misdiagnosed with AD without have AD. That so expensive misdiagnosis , can lead to catasthrophic consequences to the lives of the patients that do or did that NON reliable tests, leading to increase the insurance costs of those people, take them to deep depressions, completely change for the worse the fate of their lives, even lead to depression and despair, not only the "victims" of these inaccurate and expensive tests, but also to their family, etc.Patients and families may make wrong decisions for their lives in common, and also wrong financial decisions. In summary, the individual pays $ 3000 for a "test" with 55% chance of being something totally wrong, worthless to improve their health.

  2. Hello, why all this fuss $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$. There are so many gaps in knowledge that are ignored or jumped over or pretended they aren't there to reach the conclusion that this investment is worth while. Yes, there are lots of misdiagnosis of forms of dementia, not because we can't see them, we don't know what we are looking at. We make shit up (MSU symdrome), and then assume we are right and go on from there. We are not looking at Alzheimer's, we don't know what causes it. We are not seeing the disease. We don't know if it is mutually exclusive of other forms of dementia, if it isn't maybe there is no such category as Alzheimer's. We don't know what we don't know and we don't seem to bothered by that fact. Let's just spend more of other people's money, tell them it is for their own good, that we can fine tune the diagnosis and then fine tune non existent and mutually exclusive treatments.

    Experts int he field (none of whom I might add have actually experienced the symptoms of dementia), push the idea we are making progress, when we are still wandering around in the dark, we just have more expensive flash lights. We don't understand the big picture of dementia, we don't know what finished looks like, so when we come across something everyone jumps up and down, tries to sell it as the next giant step toward a cure and then move on. This is an example of the false hope factory at it's best and worst.Looking at a scan that no one in the room can really agree on it's meaning is a waste of time, money, effots, and produces a sense of false hope that we know what we are don't. They don't. Don't let expensive pictures fool you. In the end it is up to us, folks living with the symptoms of dementia to figure out how best to live our lives. There is no fine tuning of treatments, because there are no treatments that work in any sense of the word help us in our day to day living. There are pills to swallow, foods to eat, check lists to consult - all of whom are suggested by folks who don't have any of the symptoms of dementia. Listen to them, listen and work with us.

    more $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$, spent faster is not the answer.

    Richard Taylor, person living with the symptoms of dementia.

  3. With all due respect for the prior comments, the guy in the article's video link was pretty grateful for this technology, as well as the money spent on it.


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