The data have potentially important implications for the diagnosis of dementia, of which there are an estimated 7.7 million2 new cases each year worldwide. AD accounts for 60-80%3 of all dementia diagnoses. However, an estimated 20-30%4 of clinical diagnoses of probable AD are found to be incorrect upon post-mortem histological investigation, underscoring the need for more accurate diagnostic tools.
"Our phase III data demonstrate the accuracy and reliability of Neuraceq PET imaging in detecting beta-amyloid neuritic plaques in the brain, and supported the approvals of this radiotracer by regulatory bodies in the US and Europe," noted Andrew Stephens, Chief Medical Officer, Piramal Imaging. "We hope these findings lead to more timely diagnosis and intervention in individuals with suspected Alzheimer's disease and other forms of dementia, as well as to widespread reimbursement for the use of this innovative diagnostic tool."
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About Neuraceq™ (florbetaben F18 injection)
Indication
Neuraceq™ is indicated 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 Neuraceq™ scan indicates sparse to no amyloid 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 Neuraceq™ 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.
Neuraceq™ is an adjunct to other diagnostic evaluations.
Limitations of Use
A positive Neuraceq™ scan does not establish the diagnosis of AD or any other cognitive disorder.
Safety and effectiveness of Neuraceq™ have not been established for:
Predicting development of dementia or other neurologic conditions;
Monitoring responses to therapies.
Important Safety Information
Risk for Image Interpretation and Other Errors
Neuraceq™ can be used to estimate the density of beta-amyloid neuritic plaque deposition in the brain. Neuraceq™ is an adjunct to other diagnostic evaluations. Neuraceq™ images should be interpreted independent of a patient's clinical information. Physicians should receive training prior to interpretation of Neuraceq™ images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.
