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THE VALUE OF KNOWING A PATIENT’S AMYLOID STATUS

>60%

Patient management changed in over 60% (4159/6905) of patients with MCI 90 days after amyloid PET (compared with pre-PET plan).1

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.1

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.1

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.1

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.1

33.3%

A negative amyloid PET scan led to cognition-specific drug discontinuation in 33.3% (n=6) of previously treated patients.2

65.6%

A positive amyloid PET scan led to 65.6% (n=61) of previously untreated patients starting cognition-specific medications.2

Design: The Incremental Diagnostic Value of Amyloid PET with [18F]-Florbetapir (INDIA-FBP) study is an open-label, multicenter study involving 18 Alzheimer's disease (AD) evaluation units from Northern Italy.2

Objective: This study aimed to investigate the incremental diagnostic value of amyloid PET with florbetapir F 18 and examine routine clinical assessments of patients being evaluated for cognitive impairment.2

Population: A total of 228 consecutive adults with cognitive impairment with prescan diagnostic confidence of AD between 15% and 85%.2

Learn more about the Amyvid procedure time

PROCEDURE TIME

REFERENCES

  1. 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.
  2. Boccardi M, Altomare D, Ferrari C, et al; Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Working Group. Assessment of the incremental diagnostic value of florbetapir F 18 imaging in patients with cognitive impairment: the Incremental Diagnostic Value of Amyloid PET With [18F]-Florbetapir (INDIA-FBP) Study. JAMA Neurol. 2016;73(12):1417-1424.

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