Meet George*

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 he sometimes recalls nearly everything

George is frustrated by these changes
MOCA 24/30 with errors in recall, calculation, attention, and visuospatial skills

*Hypothetical patient.
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.

Clinical Assessment: Progressive MCI

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

Normal physical and neurological exams

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

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

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

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.

SELECT IMPORTANT SAFETY INFORMATION:
WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

  • Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
  • 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

Amyvid PET Scan Imaging Report

NEGATIVE SCAN

  • Indicates sparse to no neuritic plaques1
  • The negative scan is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition, and makes it unlikely that George’s cognitive impairment is due to AD1

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.

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.

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

WARNINGS AND PRECAUTIONS

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

MOST COMMON ADVERSE REACTIONS

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 10JAN2014