First Comprehensive Amyloid Imaging Solution1

When evaluating for Alzheimer’s disease and other causes of cognitive decline

With aging populations and extended life expectancies, the number of Alzheimer’s cases globally is growing at epidemic levels. Alzheimer’s disease is now the sixth leading cause of death in the United States. With 5.2 million Americans living with the disease—and another person joining that group every 68 seconds—this number is predicted to triple by 2050.2 As deaths from stroke, cancer and heart disease decreased significantly between 2000 and 2010, Alzheimer’s-related deaths rose 68%.2 

Siemens Healthcare is the first company to announce a comprehensive amyloid imaging solution by combining reliable PET radiopharmaceutical manufacturing and distribution with innovative hardware technologies and software1 for PET/CT imaging of amyloid plaques—one of the necessary pathological features of Alzheimer’s disease3,4,5—in the living brain.

Amyloid Imaging
For the first time in clinical practice, physicians can utilize PET imaging 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.

Deliver Reliability
Siemens' PETNET Solutions operates the largest global network of PET/CT radiopharmaceutical manufacturing facilities and dispensing nuclear pharmacies offering access to the largest portfolio of PET radiopharmaceuticals throughout the world. Siemens' PETNET Solutions has standardized equipment and procedures to ensure consistent products from all sites throughout the world. As such, every dose meets the required standards for product quality and purity, from production to labeled expiration time, enabling reliable distribution of imaging biomarkers. With this, Siemens' PETNET Solutions is able to offer imaging centers and hospi­tals a high level of delivery reliability, up to 96 percent, adding to your confi­dence in being able to scan patients as scheduled.

Quantitative Accuracy with Biograph mCT
The Biograph™ mCT PET/CT family offers you the highest image quality,6 with the market's leading 95 mm3 volumetric resolution,7 and quantifiable results that are accurate. syngo®.PET Amyloid Plaque1 is Siemens' proprietary quantification software that quantifies amyloid plaque deposits in the brain.

Beyond the Foundation
Siemens has a recognized portfolio of programs to help customers establish and grow their PET imaging offerings and provide new services to their communities starting with a personalized implementation plan and continuing with workflow, clinical and marketing support.

1 syngo.PET Amyloid Plaque is intended for use only with approved amyloid radiopharmaceuticals in the country of use. Users should review the drug labeling for approved uses.
2Alzheimer's Association, 2013 Alzheimer's Disease Facts and Figures, Alzheimer's & Dementia, Volume 9, Issue 2.
3 Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging–Alzheimer’s Association Guidelines for the Neuropathologic Assessment of Alzheimer’s Disease. Alzheimers Dement. 2012;8:1-13.
4 Mirra SS, Heyman A, McKeel D, et al; and participating CERAD neuropathologists. The Consortium to Establish a Registry for Alzheimer’s Disease (CERAD): Part II: Standardization of the Neuropathologic Assessment of Alzheimer’s Disease. Neurology. 1991;41(4):479–486.
5 Thies W, Bleiler L; Alzheimer’s Association. Alzheimer’s Association Report: 2012 Alzheimer’s Disease Facts and Figures. Alzheimers Dement. 2012;8:131-168.
6 2011 PET Image Quality Survey conducted in the U.S. and Europe as a custom study by IMV, a neutral third party market research company.
7 Based on volumetric resolution available in competitive literature for systems greater than 70 cm bore size. Data on file.

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Amyloid Imaging

Patients with symptoms of cognitive impairment can be misdiagnosed with Alzheimer's disease. In fact, up to one in five patients clinically diagnosed with probable Alzheimer’s disease during life do not have Alzheimer’s disease pathology upon autopsy.7,8

Illustration of brain with Alzheimer's disease
Illustration of brain with Alzheimer's disease

Only neuropathological examination, usually performed at autopsy, can definitively rule out Alzheimer’s disease.3 For the first time in clinical practice, physicians can now utilize PET/CT imaging 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.

Beta-amyloid plaque is one of the necessary pathological features of Alzheimer’s disease. Beta-amyloid plaques are deposits of a protein fragment called beta-amyloid that build up in the spaces between nerve cells (neurons) in the brain. In a healthy brain, beta-amyloid protein fragments are broken down and removed from the brain. In a brain with Alzheimer’s disease, beta-amyloid protein fragments accumulate to form hard, insoluble plaques in between neurons. Beta-amyloid accumulation builds over many years in the brain.9 Accumulation of beta-amyloid plaques interacts with a signal pathway that causes neurofibrillary tangles which are insoluble twisted fibers found inside the brain’s cells. As increasing amounts of plaques and tangles form in particular areas of the brain, brain cells work less efficiently, eventually losing their ability to function and, ultimately, dying. As beta-amyloid plaques are seen in other neurologic conditions and older people with normal cognition, confirmation of beta-amyloid plaques does not definitively lead to Alzheimer’s disease diagnosis. It is, therefore, important to have access to innovative technologies that can help differentiate and quantify amyloid-plaque buildup in the living brain.

3 Hyman BT, Phelps CH, Beach TG, et al. National Institute on Aging–Alzheimer’s Association Guidelines for the Neuropathologic Assessment of Alzheimer’s Disease. Alzheimers Dement. 2012;8:1-13.
7 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.
8 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.
9 Rodriguez KM, Kennedy KM, Devous MD Sr, et al. Amyloid Burden in Healthy Aging: Regional Distribution and Cognitive Consequences. Neurology. 2012;78(6):387-95.

Deliver Reliability

Two major challenges for utilizing novel imaging biomarkers are limited access and low delivery reliability. Limited access results in the inability to offer new services to communities, limiting your ability to expand your clinical offerings and ultimately grow your business.

Largest Network of Facilities
Largest Network of Amyloid Imaging Biomarker Manufacturing Facilities*

Likewise, low reliability results in patient dissatisfaction due to the need to reschedule imaging exams, which may damage the reputation between the imaging center and its referring physicians. Today, Siemens' PETNET Solutions operates the largest network of PET radiopharmaceutical manufacturing facilities for amyloid and other novel imaging biomarkers in the United States.

The combination of more complex and highly sensitive production and purification processes for next-generation PET imaging biomarkers demands the need for new production and purification techniques, as well as new manual and automated manufacturing steps. Addressing these manufacturing challenges, Siemens' PETNET solutions has standardized its equipment and training process across its entire production network to reduce the level of complexity in production. In addition, Siemens' PETNET Solutions has invested in redundant equipment for key processes to eliminate single points of failure. Finally, Siemens' PETNET Solutions employs dedicated staff and a fully-integrated operational support infrastructure for the global production of amyloid imaging biomarkers. As a result, Siemens' PETNET Solutions is able to offer imaging centers and hospitals a delivery reliability of up to 96 percent.

*Actual timing is based on local regulatory approvals at each site.

Quantitative Accuracy

Quantitative Accuracy with Biograph mCT Family

Because some amyloid tracer uptake is observed in the white matter tissue of normal brains, it is important to appropriately differentiate between white matter uptake and gray matter beta-amyloid plaque deposits.

Intelligently Reproducible Quantification with Biograph mCT Family
Biograph mCT with intelligently reproducible quantification helps physicians localize and quantify levels of amyloid plaque in the living brain

While amyloid tracer uptake within the brain’s white matter is, in most cases, considered normal, uptake in the grey matter may indicate abnormal activity.10 Because grey and white matter are interlaced in such a compact way, distinguishing the two can be challenging. Once localized, quantifying the presence of amyloid plaques may be useful when reviewing amyloid-PET images.

Traditional scanners in use today often lack the fine volumetric resolution and high-contrast ratio required to precisely differentiate between grey and white matter. Inherent scanner drift as well as inaccurate attenuation correction impact the accuracy of acquired quantitative data. In addition, conventional interpretation software does not offer automatic, validated quantification and leaves the reader to rely solely on qualitative interpretation.

With the Biograph™ mCT family from Siemens, physicians can attain the highest image quality6 and quantifiable results that are accurate. With its OptisoHD Detection System, UltraHD•PET and acquisition matrix of 400 x 400, Biograph mCT enables physicians to visualize different brain matter with the industry’s finest volumetric resolution7 of 95 mm3. With its unique combination of daily calibration and precise anatomical and functional co-registration, Biograph mCT can make a quantifiable improvement in confidence in dementia evaluation.

Siemens' syngo®.PET Amyloid Plaque1 proprietary quantification software takes a patient’s PET amyloid exam and automatically registers it against a reference model of a PET amyloid brain. syngo.PET Amyloid Plaque software enables physicians to automatically calculate SUVr. Combined with visual assessment, these capabilities provide physicians with added information about amyloid-PET images.

1 syngo.PET Amyloid Plaque is intended for use only with approved amyloid radiopharmaceuticals in the country of use. Users should review the drug labeling for approved uses.
6 2011 PET Image Quality Survey conducted in the U.S. and Europe as a custom study by IMV, a neutral third party market research company.
10 Adam S. Fleisher et al: “Using Positron Emission Tomography and Florbetapir F 18 to Image Cortical Amyloid in Patients With Mild Cognitive Impairment or Dementia Due to Alzheimer Disease”, Archives of Neurology, July 12, 2011

7 Based on volumetric resolution available in competitive literature for systems greater than 70 cm bore size. Data on file.
11 Camus et al EJNM (2012) 39:621-631; Using PET with 18F-AV-45 (florbetapir) to quantify brain amyloid load in a clinical environment; Qualitative visual assessment of the PET scan showed a sensitivity of 84.6%; however, the quantitative assessment of the global cortex SUVr showed a sensitivity of 92.3%.
13 J.-M. Peyrat, A. Joshi, M. Mintun, J. Declerck: “An Automatic Method for the Quantification of Uptake with Florbetapir Imaging”, SNM Publication No.: 210, Reference #: 1311229, http://www.snm.org/index.cfm?PageID=11533

Beyond the Foundation

It is essential to get the most from your investment when introducing new clinical services. Incomplete plans can cause unnecessary and costly delays. Inconclusive or wrong interpretation can lead to limited referral demand.

Network of Expertise
Network of Expertise

Patient access and business growth can be restricted if referring physicians are unaware of your offerings. Siemens' PETNET Solutions leverages the expertise of its field staff, who average over 10 years of experience in PET imaging, to ensure successful implementation of new imaging services. Siemens has a recognized portfolio of programs to help customers establish and grow their PET imaging offerings and provide new services to their communities. Siemens imaging outreach program includes a broad range of exclusive offerings, including business plan development, site readiness consulting, optimized scanner protocols, workflow consulting, as well as training and marketing support. Siemens offers the services to be a strong partner to support our customer’s efforts to plan, operate and grow their PET imaging business.