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CHOOSE AMYVID TO AID IN THE DIAGNOSIS OF ALZHEIMER’S DISEASE (AD)1,2

Amyvid provides objective evidence

Amyvid: PET imaging of the brain that estimates beta-amyloid plaque density in adult patients with cognitive impairment may aid in the diagnosis of AD.1-3

NEGATIVE AMYVID PET SCAN4


Brain negative Amyvid PET scan
  • Indicates sparse to no amyloid plaques
  • Inconsistent with a neuropathological diagnosis of AD
  • Unlikely that cognitive impairment is due to AD
  • 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

POSITIVE AMYVID PET SCAN5


Brain positive Amyvid PET scan
  • Indicates moderate to frequent amyloid plaques
  • Is consistent with a neuropathological diagnosis of AD
  • This amount of 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 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

©2011. Avid Radiopharmaceuticals, Inc. All rights reserved.

Amyvid scans1:

  • Are interpreted using a binary visual read methodology (negative/positive)
  • Are used as an adjunct to other diagnostic evaluations
  • Should only be read by physicians who complete a comprehensive Amyvid training program

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.1

Amyvid clinical studies:

  • Amyvid was evaluated in 3 clinical studies that examined images from healthy adult subjects as well as subjects with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program1
  • All were single-arm studies in which subjects underwent an Amyvid injection and scan and then had images interpreted by multiple independent readers who were masked to all clinical information1
  • Image interpretations used co-registration with CT scans when PET scans were performed on dual PET/CT scanners1

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.

CT=computed tomography; PET=positron emission tomography.

THE ACCURACY OF AMYVID1

Amyvid has been shown to be accurate for estimating beta-amyloid neuritic plaque density1

In a clinical trial, Amyvid identified:1

POSITIVE CASES
(sensitivity)

96%

of the time

(95% CI: 80% to 100%)

NEGATIVE CASES
(specificity)

100%

of the time

(95% CI: 78% to 100%)

Objective evidence of amyloid pathology based on autopsies performed within 1 year of Amyvid scan (n=46)1

STUDY 2 assessed the sensitivity and specificity of a binary visual read methodology in patients who underwent autopsy (truth standard).1

DESIGN1:

  • 5 readers (trained in person)
  • Binary visual read methodology

POPULATION1:

  • 59 terminally ill patients who received premortem Amyvid scans and then underwent autopsy to establish a truth standard
  • Of these 59 patients, 29 patients had an Alzheimer’s disease (AD) clinical diagnosis, 13 had another type of dementing disorder, 12 had no history of cognitive impairment, and 5 had MCI

RESULTS:

  • In patients who had an autopsy within 1 year of PET imaging (n=46)1,6:
    • 28 had moderate to frequent plaques and 18 had no or sparse neuritic plaques at autopsy
    • The majority of readers rated Amyvid PET scans as positive in 27 of the 28 individuals (1 false positive), giving a sensitivity* of 96% (95% CI: 80% to 100%)
    • The majority of readers rated Amyvid PET scans as negative in all 18 individuals (0 false negatives), which corresponded to a specificity* of 100% (95% CI: 78% to 100%)
  • In patients who had an autopsy within 2 years of PET imaging (n=59)1:
    • Sensitivity* was 92% (95% CI: 78% to 98%) and specificity* was 100% (95% CI: 80% to 100%)

Amyvid clinical studies

  • Amyvid was evaluated in 3 clinical studies that examined images from healthy adult subjects as well as subjects with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program1
  • All were single-arm studies in which subjects underwent an Amyvid injection and scan and then had images interpreted by multiple independent readers who were masked to all clinical information1
  • Image interpretations used co-registration with CT scans when PET scans were performed on dual PET/CT scanners1

*Sensitivity and specificity were calculated using the majority interpretation of the readers for the presence or absence of moderate to frequent amyloid plaques.6

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

Amyvid is reliable1

Amyvid has been shown to be reliable for estimating beta-amyloid neuritic plaque density1

Statistically significant correlation between Amyvid PET scan images and beta-amyloid plaque deposition seen at autopsy (r=0.78; 95% CI: 0.58 to 0.89; P<0.0001) (n=29).1

Negative Amyvid PET Scan Results1,4,8

NEGATIVE AMYVID PET SCANa


Brain negative Amyvid PET scan

Low Amyvid uptake in cortical gray matter

PATHOLOGY RESULTS (IMMUNOHISTOCHEMISTRY)a


Negative Amyvid PET scan of low Amyvid update in cortical grey matter and pathology results of no evidence of amyloid plaques

No evidence of amyloid plaques

aThese are examples of a negative amyloid PET scan and pathology slide with no evidence of amyloid plaques.4,8

©2011. Avid Radiopharmaceuticals, Inc. All rights reserved.

  • Indicates sparse to no amyloid plaques1
  • Inconsistent with a neuropathological diagnosis of AD1
  • Unlikely that cognitive impairment is due to AD1

Positive Amyvid PET Scan Results1,4,5

POSITIVE AMYVID PET SCANa

Brain positive Amyvid PET scan

High Amyvid uptake in cortical gray matter

PATHOLOGY RESULTS (IMMUNOHISTOCHEMISTRY)a

Positive Amyvid PET scan of high Amyvid uptake in cortical grey matter and pathology results of high levels of Amyloid plaques

High levels of amyloid plaques

aThese are examples of a positive amyloid PET scan and pathology slide with high level of amyloid plaques.4,8

©2011. Avid Radiopharmaceuticals, Inc. All rights reserved.

  • Indicates moderate to frequent amyloid plaques1
  • Is consistent with a neuropathological diagnosis of AD1
  • This amount of amyloid plaque is seen in patients with AD, but may also be present in patients with other conditions as well as cognitively normal older people1
  • A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder1

STUDY 1 assessed the correlation between amyloid plaques seen at autopsy and estimates for amyloid plaque density using Amyvid PET imaging.1

DESIGN1:

  • 3 readers
  • Semiquantitative reading methodology (not intended for clinical use)

POPULATION1:

  • 35 terminally ill patients who received premortem Amyvid scans and then underwent autopsy (29 of which comprised the primary analysis set)

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 features1

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.

The reproducibility of Amyvid1,7

Amyvid has been shown to have high inter-reader reproducibility for estimating beta-amyloid neuritic plaque density1,7

High inter-reader reproducibility

  • 92% of interpretations agreed with the majority (95% CI: 89.8% to 94.1%) (n=59)7
  • Overall Fleiss’ kappa statistic§ of 0.83 (95% CI: 0.78 to 0.88) (n=151); the lower bound of the 95% CI exceeded the prespecified success criterion1

92%

of interpretations agreed with the majority

(95% CI: 89.8% to 94.1%) (n=59)

STUDY 2 assessed the sensitivity and specificity of a binary visual read methodology in patients who underwent autopsy (truth standard).1

DESIGN1:

  • 5 readers (trained in person)
  • Binary visual read methodology

POPULATION1:

  • 59 terminally ill patientsǁ who received premortem Amyvid scans and then underwent autopsy to establish a truth standard

Study 3: Assessed the inter-and-intra-reader image interpretation reproducibility in subjects with and without autopsy (truth standard)1.

DESIGN1:

  • 5 readers (trained using electronic media)
  • Binary visual read methodology

POPULATION1:

  • 92 subjects who did not undergo autopsy (truth standard) in addition to 59 patients (same population from Study 2) with autopsy data
  • 33 randomly selected images were used to assess intra-reader reproducibility

§Fleiss’ kappa: the degree of agreement among multiple readers over that which would be expected by chance1,2.
ǁTwenty-nine (29) patients had an AD clinical diagnosis, 13 had another type of dementing disorder, 12 had no history of cognitive impairment, and 5 had MCI.1
Twenty (20) healthy volunteers, 52 patients with MCI, 20 patients with AD.1

Amyvid clinical studies1

  • Amyvid was evaluated in 3 clinical studies that examined images from healthy adult subjects as well as subjects with a range of cognitive disorders, including some terminally ill patients who had agreed to participate in a postmortem brain donation program
  • All were single-arm studies in which subjects underwent an Amyvid injection and scan and then had images interpreted by multiple independent readers who were masked to all clinical information
  • Image interpretations used co-registration with CT scans when PET scans were performed on dual PET/CT scanners

SELECT IMPORTANT SAFETY INFORMATION

Risk for Image Misinterpretation and Other Errors

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%).

Learn more about the Amyvid procedure time

PROCEDURE TIME Right

CI=confidence interval; CT=computed tomography; MCI=mild cognitive impairment; PET=positron emission tomography.

References:

  1. Amyvid (florbetapir F 18 injection) Prescribing Information. Lilly USA, LLC.
  2. 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.
  3. 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.
  4. Data on File. Lilly USA, LLC. DOF-AM-US-0006.
  5. Data on File. Lilly USA, LLC. DOF-AM-US-0007.
  6. Clark CM, Pontecorvo MJ, Beach TG, et al; for AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-β plaques: a prospective cohort study. Lancet Neurol. 2012;11(8):669-678.
  7. Data on File. Lilly USA, LLC. DOF-AM-US-0005.
  8. Data on File. Lilly USA, LLC. DOF-AM-US-0008.

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%)

AM HCP ISI 14SEP2022

Please see Full Prescribing Information for Amyvid.

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