DIFFERENTIATING ALZHEIMER'S DISEASE FROM OTHER CAUSES OF COGNITIVE IMPAIRMENT CAN BE DIFFICULT1

AD and other causes of cognitive impairment, such as Lewy Body dementia, frontotemporal dementia, and vascular dementia, share many overlapping symptoms, including deficiencies in2,3:

  • Memory
  • Visuospatial ability
  • Executive function
  • Behavior
  • Language

Alzheimer's disease is often misdiagnosed.4,5

Up to 20% of patients clinically diagnosed with probable AD during life do not have AD pathology upon autopsy.6,7

Evaluating the cause of cognitive impairment early can make a difference for your patients8-10

AD=Alzheimer's disease.

BETA-AMYLOID DEPOSITION AND PATHOLOGY OF ALZHEIMER'S DISEASE11,12

Neuritic beta-amyloid plaques may be one of the first biomarker abnormalities in AD9,13

  • The absence or presence of significant amyloid plaques can be used as a reliable biomarker after presentation of the first clinical signs and symptoms of cognitive decline1,13,14
  • Neuritic beta-amyloid plaques may also be present in patients with other types of neurologic conditions, as well as older people with normal cognition. The presence of amyloid plaques alone does not establish a diagnosis of AD or other cognitive disorders

Evidence of amyloid plaque accumulation has been shown to be present when symptoms of cognitive impairment, due to AD, appear10,14,15

  • May precede the appearance of clinical symptoms by approximately 20 years

At the first sign of clinical symptoms, act early to help detect the cause of your patient's cognitive impairment

AD=Alzheimer's disease.

IN CONJUNCTION WITH CLINICAL ASSESSMENT AMYVID CAN HELP DIFFERENTIATE THE CAUSE OF COGNITIVE DECLINE1,11,12

Amyvid scans are interpreted using a binary visual read methodology (negative/positive)11

The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid neuritic plaque density, not to make a clinical diagnosis. Image interpretation is performed independently of a patient's clinical features and relies upon the recognition of unique image features.

Amyvid scans should only be read by physicians who complete a comprehensive Amyvid training program11

ACCESS READER TRAINING

A NEGATIVE AMYVID PET SCAN16

Brain negative Amyvid PET scan

Low Amyvid uptake in cortical gray matter (good gray-white matter contrast)

  • Indicates sparse to no neuritic amyloid plaques
  • Inconsistent with a neuropathological diagnosis of AD at the time of image acquisition
  • Unlikely that cognitive impairment is due to AD

A POSITIVE AMYVID PET SCAN17

Brain Positive Amyvid PET scan

High Amyvid uptake in cortical gray matter (loss of gray-white matter contrast)

  • Indicates moderate to frequent neuritic amyloid plaques
  • Is consistent with a neuropathological diagnosis of AD
  • This amount of neuritic amyloid plaque is seen in patients with AD, but may also be present in patients with other types of neurologic conditions as well as cognitively normal older people
  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder

AD=Alzheimer's disease; PET=positron emission tomography.

SELECT IMPORTANT SAFETY INFORMATION:

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid 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 Amyvid 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 Amyvid scan as well as motion artifacts that distort the image
  • Amyvid 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

THE VALUE OF KNOWING AMYLOID STATUS

NEGATIVE SCAN

Brain negative Amyvid PET scan

KNOW

  • Unlikely that the cause of their cognitive decline is due to AD11

ACT

  • Potential to avoid unnecessary treatments18-20
  • Together, you and your patient can continue looking into other possible causes of their cognitive impairment

POSITIVE SCAN

Brain Positive Amyvid PET scan

KNOW

  • Evidence of moderate to frequent beta-amyloid plaques in the brain is consistent with a neuropathological diagnosis of AD11

ACT

  • Scan results along with clinical assessment may help you decide appropriate diagnosis and management21
  • Together, you and your patient can determine an appropriate treatment plan
  • Beta-amyloid plaques may also be present in patients with other types of neurologic conditions, as well as older people with normal cognition
  • The presence of amyloid plaques alone does not establish a diagnosis of AD or other cognitive disorders
  • The objective of Amyvid image interpretation is to provide an estimate of the brain beta-amyloid plaque density, not to make a clinical diagnosis
Alzheimer's Disease patient case study George

Almost 9 of 10 people in the US who were surveyed said that they would rather know if Alzheimer's disease (AD) is the source of their cognitive impairment.22

See what to expect with Amyvid

LEARN MORE

AD=Alzheimer's disease.

SELECT IMPORTANT SAFETY INFORMATION:

Radiation Risk

  • Amyvid, 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

References

  1. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:263-269.
  2. Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue Bank/University of Barcelona/Hospital Clínic NTB/UB/HC Collaborative Group. Clinical features and APOE genotype of pathologically proven early-onset Alzheimer disease. Neurology. 2011;76(20):1720-1725.
  3. Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016;12(4):459-509.
  4. Beach TJ, Monsell SE, Phillips LE, Kukull W. Accuracy of the clinical diagnosis of Alzheimer disease at National Institute on Aging Alzheimer Disease Centers, 2005-2010. J Neuropathol Exp Neurol. 2012;71(4):266-273.
  5. Knopman DS, DeKosky ST, Cummings JL, et al. Practice parameter: diagnosis of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2001;56(9):1143-1153.
  6. 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.
  7. 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.
  8. Hort J, O'Brien JT, Gainotti G, et al. EFNS guidelines for the diagnosis and management of Alzheimer's disease. Eur J Neurol. 2010;17(10):1236-1248.
  9. Aisen PS, Cummings J, Jack CR Jr, et al. On the path to 2025: understanding the Alzheimer's disease continuum. Alzheimers Res Ther. 2017;9(1):1-10.
  10. McDade E, Bednar M, Brashear HR, et al. The pathway to secondary prevention of Alzheimer's disease. Alzheimers Dement (N Y). 2020;6(1):1-9.
  11. Amyvid [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
  12. Jack CR Jr, Albert MS, Knopman DS, et al. Introduction to the recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):257-262.
  13. Jack CR Jr, Knopman DS, Jagust WJ, et al. Tracking pathophysiological processes in Alzheimer's disease: an updated hypothetical model of dynamic biomarkers. Lancet Neurol. 2013;12(2):207-216.
  14. Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012;8(1):1-13.
  15. Villemagne VL, Burnham S, Bourgeat P, et al; for the Australian Imaging Biomarkers and Lifestyle (AIBL) Research Group. Amyloid ß deposition, neurodegeneration, and cognitive decline in sporadic Alzheimer's disease: a prospective cohort study. Lancet Neurol. 2013;12(4):357-367.
  16. Data on File, Lilly USA, LLC, DOF-AM-US-0008.
  17. Data on File, Lilly USA, LLC, DOF-AM-US-0007.
  18. Ty D, McDermott M. Building workforce capacity to improve detection and diagnosis of dementia. Milken Institute; 2021. https://milkeninstitute.org/sites/default/files/2021-05/Building%20Dementia%20Workforce.pdf. Accessed August 12, 2021.
  19. Mendez MF, Shapira JS, McMurtray A, et al. Preliminary findings: behavioral worsening on donepezil in patients with frontotemporal dementia. Am J Geriatr Psychiatry. 2007;15(1):84-87.
  20. Alzheimer's Disease International. World Alzheimer Report 2011: the benefits of early diagnosis and intervention.https://www.alz.co.uk/research/WorldAlzheimerReport2011.pdf. Published 2011. Accessed October 19, 2016.
  21. Dubois B, Padovani A, Scheltens P, Rossi A, Dell'Agnello G. Timely diagnosis for Alzheimer's disease: a literature review on benefits and challenges. J Alzheimers Dis. 2016;49(3):617-631.
  22. Blendon RJ, Benson JM, Wikler EM, et al. The impact of experience with a family member with Alzheimer's disease on views about the disease across five countries. Int J Alzheimers Dis. 2012;2012:1-9.

INDICATION

Amyvid is a radioactive diagnostic agent 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 Amyvid 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 Amyvid 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. Amyvid is an adjunct to other diagnostic evaluations.

Amyvid for intravenous use is supplied in multidose vials containing 500-1900 MBq/mL Florbetapir F 18.

Limitations of Use:

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

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid 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 Amyvid 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 Amyvid scan as well as motion artifacts that distort the image
  • Amyvid 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

  • Amyvid, 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

MOST COMMON ADVERSE REACTIONS

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%)

Please see full Prescribing Information for Amyvid.

AM HCP ISI 10JAN2014