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ALZHEIMER’S DISEASE (AD) CAN BE DIFFICULT TO DIAGNOSE1-3

An AD diagnosis can be challenging due to overlapping symptoms with other causes of cognitive impairment, particularly in early stages when symptoms may mimic the natural aging process.

Objective evidence can help increase confidence in AD diagnosis3-5

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With the approval of amyloid-targeting therapies, confirming amyloid pathology as early as possible is more important than ever for patients being assessed for AD.2,6,7

  • Nearly 1 in 3 people clinically diagnosed with AD based on symptoms did not test positive for amyloid plaques8-10
  • Knowing that β-amyloid plaques are not present may support the choice to assess for other causes of cognitive impairment and help avoid unnecessary treatment11-14

Diagnosis of AD is often 2-3 years after symptom onset. Imagine how having objective evidence of the presence or absence of AD pathology earlier could help you to make a more confident and timely diagnosis than clinical evaluation alone.2,15-19

Based on a comparison of diagnostic confidence pre- and post-amyloid PET scans in a study of patients with cognitive impairment of unknown etiology or suspected AD, diagnostic uncertainty was reduced from 72% before amyloid PET to 16% after amyloid PET scan.8

Learn more about the efficacy of Amyvid

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PET=positron emission tomography.

References:

  1. Alzheimer's Association. 2022 Alzheimer's disease facts and figures. Alzheimers Dement. 2022;18(4):700-789.
  2. Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of early Alzheimer’s disease: clinical practice in 2021. J Prev Alzheimers Dis. 2021;8:371-386.
  3. 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(3):263-269.
  4. Amyvid (florbetapir F 18 injection) Prescribing Information. Lilly USA, LLC.
  5. Clark CM, Schneider JA, Bedell BJ, et al; for the AV45-A07 Study Group. Use of florbetapir-PET for imaging β-amyloid pathology. JAMA. 2011;305(3):275-283.
  6. Pemberton HG, Collij LE, Heeman F, et al; on behalf of AMYPAD consortium. Quantification of amyloid PET for future clinical use: a state-of-the-art review. Eur J Nucl Med Mol Imaging. 2022;49(10):3508-3528.
  7. 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):60. doi:10.1186/s13195-017-0283-5
  8. Rabinovici GD, Gatsonis C, Apgar C, et al. Association of amyloid positron emission tomography with subsequent change in clinical management among Medicare beneficiaries with mild cognitive impairment or dementia. JAMA. 2019;321(13):1286-1294.
  9. 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;27(1):4-15.
  10. Jack CR Jr, Bennett DA, Blennow K, et al. NIA-AA Research Framework: toward a biological definition in Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535-562.
  11. Ty D, McDermott M. Building workforce capacity to improve detection and diagnosis of dementia. Milken Institute; 2021. Accessed August 12, 2021. https://milkeninstitute.org/sites/default/files/2021-05/Building%20Dementia%20Workforce.pdf
  12. Prince M, Bryce R, Ferri C. World Alzheimer Report 2011: the benefits of early diagnosis and intervention. Alzheimer’s Disease International; September 2011. Accessed October 19, 2016. https://www.alz.co.uk/research/WorldAlzheimerReport2011.pdf
  13. Weidman DA, Zamrini E, Sabbagh MN, et al. Added value and limitations of amyloid-PET imaging: review and analysis of selected cases of mild cognitive impairment and dementia. Neurocase. 2017;23(1):41-51.
  14. Shea YF, Barker W, Greig-Gusto MT, et al. Utility of amyloid PET scans in the evaluation of patients presenting with diverse cognitive complaints. J Alzheimers Dis. 2018;66(4):1599-1608.
  15. Balasa M, Gelpi E, Antonell A, et al; for 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.
  16. Boccardi M, Altomare D, Ferrari C, et al. et al; Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Working Group. Assessment of the incremental diagnostic value of florbetapir F 18 imaging in patients with cognitive impairment: the Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Study. JAMA Neurol. 2016;73(12):1417-1424.
  17. Dubois B, Padovani A, Scheltens P, et al. Timely diagnosis for Alzheimer’s disease: a literature review on benefits and challenges. J Alzheimers Dis. 2016;49(3):617-631.
  18. Porteri C, Albanese E, Scerri C, et al; Geneva Task Force for the Roadmap of Alzheimer’s Biomarkers. The biomarker-based diagnosis of Alzheimer’s disease. 1—ethical and societal issues. Neurobiology Aging. 2017;52:132-140.
  19. Liss JL, Seleri Assunção S, Cummings J, et al. Practical recommendations for timely, accurate diagnosis of symptomatic Alzheimer’s disease (MCI and dementia) in primary care: a review and synthesis. J Intern Med. 2021;290(2):310-334.

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

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

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 14SEP2022

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