CONSIDER AMYLOID PLAQUE BIOMARKER TESTING AS THE NEXT STEP FOR YOUR PATIENTS

Patient profile with text surrounding: family history of AD, trouble concentrating, misplacing items

Amyvid is used 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. Amyvid is an adjunct to other diagnostic evaluations.3

Consider Amyvid for your patients who:

  • Are displaying signs of cognitive impairment where AD is suspected3
  • Have undergone an initial workup (labs, cognitive assessment, EEG, MRI)4,5
  • Are concerned about memory slips
  • Want to know what may be the cause of their cognitive impairment
  • Are open to treatment and want an informed diagnosis to inform next steps

EEG = electroencephalogram; MRI=magnetic resonance imaging.



SELECT 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.

Choose Amyvid to aid in the diagnosis of AD3,6

See how Amyvid can fit into your patient’s diagnostic plan

Patient profile image with text surrounding: memory issues, anxiety, repeating stories, forgetting appointments

Amyvid is used 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. Amyvid is an adjunct to other diagnostic evaluations.3

70-year-old retired music teacher pulling vinyl record from sleeve

*Hypothetical patient.

  • 70-year-old art teacher—widowed since 2012
  • Enjoys painting and being with her 3 grandchildren
  • Arrives 30 minutes late for her visit, seems anxious
  • Describes her morning as “chaos” trying to get her grandchildren to school
  • Reports more difficulty with memory for the past 2 years and asks, “This is just normal for my age, right?”
  • Repeated the same story about her morning twice
  • MMSE 26 /30

Clinical Assessment: MCI

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Complete history and physical are normal, including neurological exam—reveals no focal deficits

Blue beaker icon

Routine lab tests normal, as well as TSH, B12, and folate

Blue PET scan icon

Structural MRI is read as "age-appropriate atrophy"

Blue people icon

Diagnosis is MCI: Follow-up scheduled in 3 months—family member is requested to attend

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An Amyvid PET scan is ordered to differentiate diagnosis and help determine, along with Charlotte, on appropriate management

Amyvid PET Scan Imaging Report

POSITIVE SCAN†3

  • Indicates presence of significant (moderate to frequent ) amyloid neuritic plaques
  • Consistent with a neuropathological diagnosis of Alzheimer’s disease (AD )
  • 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. A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Amyvid have not been established for predicting the development of dementia or other neurologic condition, or for monitoring responses to therapies
SEE POSITIVE SCAN

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.3

PROCEDURE: BRAIN AMYLOID PET/CT SCAN

HISTORY: Cognitive impairment

COMPARISON: None

RADIOPHARMACEUTICAL: 10mCi Amyvid (florbetapir F 18)

TECHNIQUE: PET/CT imaging was performed 30-50 minutes following the intravenous administration of 10mCi Amyvid (florbetapir F 18). Images were obtained from the level of the vertex to the base of the skull. Axial, sagittal, and coronal PET reconstructions were acquired.

Corresponding CT images were reviewed in axial, coronal, and sagittal planes. CT scan was a limited noncontrast study and used for anatomical correlation and attenuation correction.

COMMENT: There is diffusely increased tracer uptake throughout the cortical cerebral gray matter. Most intense uptake is seen in the prefrontal, lateral temporal, and parietal areas, with these areas showing clear loss of the normal gray-white contrast. The cerebellum has no evidence of abnormal uptake.

Tracer distribution is otherwise unremarkable.

CT (NONDIAGNOSTIC, PERTINENT FINDINGS ONLY): There is mild cerebral volume loss without mass effect or midline shift.

IMPRESSION: Positive scan, indicating moderate to frequent beta-amyloid neuritic plaques

NOTE: 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 and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease at the time of image acquisition; a negative scan result reduces likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease. 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 Alzheimer’s disease, but may be also present in patients with other types of neurologic conditions as well as older patients with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

LIMITATIONS OF USE:

  1. A positive Amyvid scan does not establish a diagnosis of Alzheimer’s disease or other cognitive disorder
  2. Safety and effectiveness of Amyvid have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring response to therapies

Example of a positive Amyvid PET scan imaging report.

CT=computed tomography; MCI=mild cognitive impairment; MMSE=Mini-Mental State Examination; PET=positron emission tomography; TSH=thyroid-stimulating hormone

Amyvid PET scans are interpreted independently of the patient’s clinical information.

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. 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.

Patient profile image with text surrounding: worsening memory, social withdrawal, communication problems, difficulty with numbers

Amyvid is used 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. Amyvid is an adjunct to other diagnostic evaluations.3

Older couple looking at one another at dinner table

*Hypothetical patient.

  • 71-year-old accountant with cognitive concerns
  • Accompanied to doctor’s office by his wife of 40 years
  • Wife describes his progressive change over the past 3 years
  • Gradually lost ability to work with numbers; his wife now manages their finances
  • Used to enjoy lively dinner conversation; now he is less talkative
  • His memory is worse, but sometimes recalls nearly everything
  • Paul is frustrated by these changes
  • MOCA 24 /30 with errors in recall, calculation, attention, and visuospatial skills

Clinical Assessment: Progressive MCI

Blue checklist icon

Medical history is remarkable for hypertension, type 2 diabetes, and gout. No previous stroke symptoms

Blue brain head icon

Normal physical and neurological exams

Blue beaker icon

Routine lab tests normal, as well as B12, folate, and TSH

Blue PET scan icon

Structural MRI outcomes: small bilateral lacunar infarcts, small vessel ischemic changes, and age-appropriate atrophy

Blue checkmark icon

An Amyvid PET scan is ordered due to the progressive nature of Paul’s cognitive decline and uncertain diagnosis

Amyvid PET Scan Imaging Report

NEGATIVE SCAN†3

  • Indicates sparse to no neuritic plaques
  • The negative scan is inconsistent with a neuropathological diagnosis of Alzheimer’s disease (AD ) at the time of image acquisition, and makes it unlikely that George’s cognitive impairment is due to AD
SEE NEGATIVE SCAN

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.

PROCEDURE: BRAIN AMYLOID PET/CT SCAN

HISTORY: Cognitive impairment

COMPARISON: None

RADIOPHARMACEUTICAL: 10mCi Amyvid (florbetapir F 18)

TECHNIQUE: PET/CT imaging was performed 30-50 minutes following the intravenous administration of 10mCi Amyvid (florbetapir F 18). Images were obtained from the level of the vertex to the base of the skull. Axial, sagittal, and coronal PET reconstructions were acquired.

Corresponding CT images were reviewed in axial, coronal, and sagittal planes. CT scan was a limited noncontrast study and used for anatomical correlation and attenuation correction.

COMMENT: There is no increased tracer uptake seen in the cortical cerebral gray matter. The brain shows normal gray-white contrast throughout. The cerebellum has no evidence of abnormal uptake.

Tracer distribution is otherwise unremarkable.

CT (NONDIAGNOSTIC, PERTINENT FINDINGS ONLY): There is mild cerebral volume loss without midline shift or mass effect.

IMPRESSION: Negative scan, indicating sparse to no beta-amyloid neuritic plaques

NOTE: 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 and other causes of cognitive decline.

A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease at the time of image acquisition; a negative scan result reduces likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease. 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 Alzheimer’s disease, but may be also present in patients with other types of neurologic conditions as well as older patients with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

LIMITATIONS OF USE:

  1. A positive Amyvid scan does not establish a diagnosis of Alzheimer’s disease or other cognitive disorder
  2. Safety and effectiveness of Amyvid have not been established for:
    • Predicting development of dementia or other neurologic condition
    • Monitoring response to therapies

Example of a negative Amyvid PET scan imaging report.

CT=computed tomography; MCI=mild cognitive impairment; MoCA=Montreal Cognitive Assessment; PET=positron emission tomography.

Amyvid PET scans are interpreted independently of the patient’s clinical information.

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. 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.

Learn about the importance of AD pathology

ACT EARLY

References:

  1. Gauthier S, Rosa-Neto, P, Morais JA, et al. World Alzheimer Report 2021: Journey Through the Diagnosis of Dementia. London, England: Alzheimer’s Disease International; 2021. Accessed January 25, 2023. https://www.alzint.org/u/World-Alzheimer-Report-2021.pdf
  2. DiBenedetti DB, Slota C, Wronski SL, et al. Assessing what matters most to patients with or at risk for Alzheimer’s and care partners: a qualitative study evaluating symptoms, impacts, and outcomes. Alzheimers Res Ther. 2020;12(1):90. doi: 10.1186/s13195-020-00659-6
  3. Amyvid (florbetapir F 18 injection). Prescribing Information. Lilly USA, LLC.
  4. 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.
  5. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment 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):270-279.
  6. 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.

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