Monarch PET/CT to Begin Using Amyvid® to Rule Out Alzheimer's Disease

BLUE BELL, Pa., Oct. 8, 2012 /PRNewswire-iReach/ -- Monarch PET/CT to Begin Using Amyvid® to Rule Out Alzheimer's Disease – 

Amyvid® is the first and only radioactive diagnostic agent approved for PET imaging of beta-amyloid neuritic plaques in the living brain.  Amyvid® is known generically as Florbetapir.  It is the first of a new generation of imaging agents based on the chemical F18 that are certain to change the landscape of Alzheimer's diagnosis, treatment and research.

Monarch PET/CT, the premier provider of outpatient PET/CT diagnostic imaging services in the country, will begin to offer Amyvid® for PET/CT imaging of the brain at 2 of our PA facilities:

Doylestown Hospital Campus, 599 West State St, Ste 102, Doylestown PA 18901 (215)345-2181

Chester County PET Assoc, 701 East Marshall St, West Chester PA 19380 (610)495-0060

Alzheimer's disease is the most common cause of dementia—a group of brain disorders that cause progressive loss of intellectual/social skills, severe enough to interfere with day-to-day life.  In Alzheimer's disease, brain cells degenerate and die, causing a steady decline in memory and mental function.

Amyvid® is a radioactive diagnostic agent for 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 & other causes of cognitive decline.  A negative Amyvid® scan indicates sparse to no neuritic plaques & is inconsistent with a neuropathological diagnosis of Alzheimer's Disease at the time of image acquisition; a negative scan result reduces the 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 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® is a radioactive diagnostic agent tagged with a radioisotope called fluorine-18.  Once Amyvid® is injected into a vein, it travels through the bloodstream & into the brain, binding to amyloid plaques.  Amyvid® produces a positron signal, which is detected by a PET scanner and used to create a brain image.  A radiologist, who should have successfully completed Amyvid® reader training, then interprets the image to evaluate for the presence or absence of significant amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain.  This information is reported back to the referring physician, who then determines the next steps in the evaluation/management of the patient.

Alzheimer's Disease is 1 of several possible causes of cognitive decline.  Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms including memory, visuospatial ability, executive function, behavior and language deficiencies. [4,7] Because a definitive diagnosis of Alzheimer's Disease is usually determined upon autopsy, [8] physicians rely on medical hx, clinical examination & a variety of diagnostic tools when evaluating patients. [4]

"It's estimated that 1 in 5 patients clinically diagnosed with probable Alzheimer's Disease during life do not end up having Alzheimer's Disease pathology upon autopsy," [9,10] said Daniel Skovronsky, M.D., Ph.D., president and CEO of Avid, and global brand development leader for Amyvid® at Lilly.  "The approval of Amyvid® offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients."

For patients who already have some symptoms of cognitive decline, a positive scan suggests that moderate to frequent amyloid plaques are present in the brain, which is consistent with Alzheimer's disease.

If the scan is negative, indicating no clumps or few clumps of amyloid, "it gives the clinician a clue that Alzheimer's is less likely to be the cause of those symptoms," said Daniel Skovronsky, who developed the agent and is the global brand-development leader for Amyvid® at Lilly.  For those patients, doctors can then look for other potential causes of the memory decline, which may have another prognosis or be treated differentially than Alzheimer's, "There are a lot of patients who have been groping in the dark for some time now, & here's an opportunity to shine a light in their brain and find out if there's amyloid or not," Dr. Skovronsky said.

"Florbetapir gives patients with cognitive decline, their families & the physicians who treat them, more information about the amyloid plaques that may be found in their brain," said the late R. Edward Coleman, M.D., professor of radiology, Duke University Medical Center.  "This approval marks a great advancement in nuclear medicine practice, as it enables us to evaluate the presence or absence of moderate to frequent levels of amyloid plaques in a patient's brain.  In conjunction with other tests, Florbetapir may help give physicians additional information when evaluating patients for the cause of their cognitive decline."

This press release contains certain forward-looking statements about Amyvid®, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer's Disease & other causes of cognitive decline.  This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks/uncertainties in the process of development and commercialization.  There is no guarantee that future study results and patient experience will be consistent with study findings to date or that the product will prove to be commercially successful.

©Lilly USA, LLC 2012. All rights reserved. AM76164
Amyvid® is a trademark of Eli Lilly & Co P-LLY

[4] Thies W, Bleiler L; Alzheimer's Association. Alzheimer's Association report: 2012 Alzheimer's disease facts & figures. Alzheimers Dement. 2012;8:131-168.

[7] Balasa M, Gelpi E, Antonell A, et al; for the Neurological Tissue Bank/University of Barcelona/Hospital Clínic NTB/UB/HC Collaborative Group. Clinical features & APOE genotype of pathologically proven early-onset Alzheimer Disease. Neurology.2011;76(20):1720–1725.

[8] Piccini A. CSF biomarkers. Open Nucl Med J. 2010;2:25-30.

[9] Lim A, Tsuang D, Kukull W, et al. Clinico-neuropathological correlation of Alzheimer's disease in a community-based case series. J Am Geriatr Soc. 1999;47(5):564–569.

[10] Petrovitch H, White LR, Ross GW, et al. Accuracy of clinical criteria for AD in the Honolulu-Asia Aging Study, a population-based study. Neurology. 2001;57(2):226–234.

Media Contact: Meghan McCurry Monarch PET/CT, 610-993-1640 ext. 212,

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