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CONFIRMING THE PRESENCE OF ALZHEIMER’S DISEASE (AD) PATHOLOGY IS MORE IMPORTANT THAN EVER

With new therapies focusing on earlier stages in the disease continuum, confirming the presence of AD pathology to aid in determining an AD diagnosis as early as possible is essential.1,2

Acknowledging the presence or absence of AD biomarkers—like beta-amyloid plaques—at symptom onset, in combination with clinical assessment in patients with MCI, may allow for a more informed decision, an earlier diagnosis, and consideration of timely treatment options.1,3,4

Knowing that beta-amyloid plaques are not present may support the choice to assess for other causes of cognitive impairment and help avoid unnecessary treatment.5-8

Learn more about the diagnostic challenges of AD and how Amyvid can help

DIAGNOSTIC CHALLENGES

References:

  1. 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.
  2. 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
  3. 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.
  4. Sabbagh MN, Lue LF, Fayard D, et al. Increasing precision of clinical diagnosis of Alzheimer’s disease using a combined algorithm incorporating clinical and novel biomarker data. Neurol Ther. 2017;6(suppl 1):S83-S95.
  5. 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
  6. 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
  7. 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.
  8. 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.

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