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
  • In her mid-60s, a retired grandmother*
  • Enjoys long hikes in nature, cooking with her husband, and spending time with her granddaughter
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  • Concerned about memory slips and how they impact her ability to maintain strong connections with her family
  • Proactive about her health and will discuss memory slip concerns with her doctor
  • Motivated to maintain her independence and is open to potential treatment options to manage her memory issues
  • Has undergone initial workup (labs, cognitive assessment, MRI, etc)
  • MMSE 26/30

*Hypothetical patient.

Clinical Assessment: MCI

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

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

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Structural MRI is read as "age-appropriate atrophy"

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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

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 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.3

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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.

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