AMYVID CAN HELP DIFFERENTIATE THE CAUSE OF COGNITIVE DECLINE, WHEN USED IN CONJUNCTION WITH CLINICAL ASSESSMENT1-3

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.

The value of knowing amyloid status

Understanding the value of a negative Amyvid PET scan:

Brain negative Amyvid PET scan

Negative Scan

A NEGATIVE AMYVID PET SCAN1,4

  • Low Amyvid uptake in cortical gray matter (good gray-white matter contrast)
  • Indicates sparse to no β-amyloid plaques

THE VALUE OF A NEGATIVE AMYLOID PET SCAN

KNOW

  • Unlikely that Alzheimer’s disease (AD) is the cause of cognitive decline, as results are inconsistent with the neuropathological diagnosis of AD1

ACT

  • Potential to avoid unnecessary treatments5,6
  • Together, you and your patient can continue looking into other possible causes of their cognitive impairment

Understanding the value of a positive Amyvid PET scan:

Brain positive Amyvid PET scan

Positive Scan

A POSITIVE AMYVID PET SCAN1,7

  • High Amyvid uptake in cortical gray matter (loss of gray-white matter contrast)
  • Indicates moderate to frequent β-amyloid plaques
    • This amount of β-amyloid plaque is seen in patients with AD, but may also be present in patients with other conditions as well as cognitively normal older people
  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder

THE VALUE OF A POSITIVE AMYLOID PET SCAN

KNOW

  • Evidence of moderate to frequent β-amyloid plaques in the brain is consistent with a neuropathological diagnosis of AD1

ACT

  • Scan results, along with clinical assessment, may help you decide on appropriate diagnosis and management8
  • Together, you and your patient can arrive at a comprehensive, well-informed diagnosis and take appropriate next steps
  • The presence of amyloid plaques alone does not establish a diagnosis of AD or other cognitive disorders1
  • The objective of Amyvid image interpretation is to provide an estimate of the brain β-amyloid plaque density, not to make a clinical diagnosis1

SELECT IMPORTANT SAFETY INFORMATION
Risk for Image Misinterpretation and Other Errors
Errors may occur during Amyvid image interpretation. Image interpretation should be performed independently of the patient’s clinical information. Amyvid scan results are indicative of plaque content only at the time of image acquisition and a negative scan does not preclude the development of brain amyloid in the future.

Before using an amyloid PET scan, physicians' confidence in an AD diagnosis was reported as uncertain 72.4% (95% CI: 71.6% to 73.3%) of the time.*
After using an amyloid PET scan, diagnostic uncertainty fell to 16.2% (95% CI: 15.5% to 16.9%).

*Uncertainty=4-7 on the Likert scale.9

Design: The Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) study: A single-group, multisite longitudinal study assessing the association between amyloid PET and subsequent changes in clinical management among Medicare patients who have MCI or dementia. Amyvid was one of three tracers used in this study.9

Objective: This study aimed to determine if amyloid PET is associated with subsequent changes in the management of patients with MCI or dementia of uncertain etiology with post hoc analyses to determine change in diagnostic confidence. The results of the reported analyses should be interpreted as exploratory.9

An additional 90-day follow-up appointment was required after the initial PET scan. At this visit, the referring specialist completed a post-PET case report to document the implemented patient management plan as well as record any changes in their diagnosis and their diagnostic confidence.9

Population: A total of 946 dementia specialists at 595 US sites enrolled 16,008 patients in the IDEAS study between February 2016 and September 2017. Of these, 11,409 had complete information and were included in the final analysis data set.9

See why it’s important to know a patient’s amyloid status

VALUE OF KNOWING Right

PET=positron emission tomography.

REFERENCES

  1. Amyvid (florbetapir F 18 injection) Prescribing Information. Lilly USA, LLC.
  2. 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.
  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. Data on File. Lilly USA, LLC. DOF-AM-US-0008.
  5. 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.
  6. 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.
  7. Data on File. Lilly USA, LLC. DOF-AM-US-0007.
  8. 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.
  9. 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.

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