Amyloid imaging lights up SNM 2012
June 14, 2012
by Loren Bonner, DOTmed News Online Editor
Presenters at the 59th annual SNM meeting in Miami Beach, Fla., unveiled an array of breakthrough research and new techniques to detect evidence of Alzheimer's in living patients -- including, possibly, in asymptomatic populations.
Researchers know that beta-amyloid plaque can build up in the brain several years before an individual shows any signs of dementia. And many scientists believe that this plaque can kill vital neural pathways that are responsible for language, memory and behavior.
"Molecular imaging can detect signs of Alzheimer's disease many years before patients develop dementia. It can do this because it can target beta-amyloid," says Dr. Christopher Rowe, a lead investigator for the Australian Imaging, Biomarkers and Lifestyle study of aging and professor of nuclear medicine at Austin Hospital in Melbourne, Australia.
In one of the studies presented by Rowe's team, PET was combined with an F-18 imaging agent. Subjects who showed high levels of the tracer during imaging had an 80 percent chance of developing Alzheimer's within two years, according to study findings.
Research also found that beta-amyloid plaque in the brain was not only involved in the pathology of Alzheimer's disease but also preceded mild cognitive function.
"For those with mild memory problems who had a positive scan, 66 percent of these people progressed to dementia over three years. This compares to only 7 percent of those with a negative scan," says Rowe.
Rowe highlighted findings on this study at the meeting, which included 194 healthy elderly subjects, 92 subjects with mild cognitive impairment, and 70 subjects with Alzheimer's. C-11 Pittsburgh compound B (PiB) combined with PET was used to gauge amyloid burden in the brain.
"This is an opportunity to find the patient who has Alzheimer's and intervene with treatments as they become available," says Rowe.
He pointed out that being able to correctly identify which patients have Alzheimer's and which don't is a necessary stepping stone for developing potential drugs and therapies to treat the disease.
Alzheimer's can only be detected in a patient after death-- by studying postmortem brain samples with beta-amyloid plaque.
Currently, no reliable treatment exists for Alzheimer's patients and the screening tests that do exist are unreliable and limited in their ability to identify the disease early.
New biomarkers emerge
Any PET amyloid imaging test must begin with a biomarker. This year's SNM meeting presented some promising amyloid imaging agents in development that will help clinicians detect Alzheimer's in living patients.
GE Healthcare's Flutemetamol 18F is a PET imaging agent in development for the detection of beta-amyloid plaque. Data from studies presented at the meeting not only show that this agent correlates with beta-amyloid through in vivo biopsy using PET technology, but data also shows that it can be measured in patients who do not exhibit symptoms of the disease yet.
"Flutemetamol has completed phase III trials and our filing with the FDA is imminent," says a GE spokesperson.
Study findings presented on a late-stage imaging agent from Piramal Imaging, recently formed through the acquisition of worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG, added to this collection of beta-amyloid biomarker research.
Dr. Ludger Dinkelborg, CEO and co-founder of Piramal, spoke about a phase III trial of his company's leading compound, florbetaben, for beta-amyloid PET imaging on six different regions of the brain. The study is unique, not only because it looks at different regions of the brain, but also because it incorporates MRI screening.
"Because PET doesn't have a high spatial resolution, we combined this study with an MRI," says Dinkelborg.
Regional MRI-PET co-registered data were analyzed by three independent blinded readers.
"We now have data on all the regions of the brain and data on histochemistry showing: is the protein [amyloid] there? How much of the protein is there? And in the six regions are there differences?" says Dinkelborg.
The Siemens solution
Siemens Healthcare announced a first-time integrated amyloid imaging solution for detecting Alzheimer's disease.
"We want to provide it as a package to assist in the evaluation of Alzheimer's and other cognitive decline," says Alexander Zimmermann, vice president of marketing and sales for Siemens molecular imaging division.
PETNET Solutions, a Siemens subsidiary, entered a deal last November with Eli Lilly & Company to manufacture and distribute Amyvid, an amyloid imaging agent approved by the FDA in April. Currently, Siemens PETNET Solutions has nine amyloid imaging manufacturing facilities across the country. Because PET biomarkers have short half-lives, this will expand to 16 more manufacturing centers by the end of year to ensure greater access to the biomarker. To reduce production complexity, Siemens has standardized its equipment across the centers and specially trained its technicians to improve the process.
"You can now say with certainty to a business that it will be there at 9 a.m. Monday morning," says Zimmermann.
The new integrated solution also includes the Siemens Biograph mCT scanner, the new PET/CT system that incorporates reproducible quantification, as well as syngo.PET Amyloid Plaque quantification software, which just received FDA 510(k) clearance this week.
More efforts are underway
Alzheimer's disease affects an estimated 18 million people worldwide. It's projected to double to 34 million by 2025, according to the World Health Organization. Another concern is the global financial impact of the disease. In 2010, it was estimated that Alzheimer's cost the world more than $604 billion, and that figure is only expected to rise.
Although research into the pathology of the disease has advanced in recent years, as seen by what was on display at SNM 2012 to image beta-amyloid plague in the brain, there is still a significant amount of work to be done. In recognition of this, the U.S. government launched the National Alzheimer's Plan in May, which will funnel $156 million into finding effective ways to prevent and treat the disease by 2025.
Researchers know that beta-amyloid plaque can build up in the brain several years before an individual shows any signs of dementia. And many scientists believe that this plaque can kill vital neural pathways that are responsible for language, memory and behavior.
"Molecular imaging can detect signs of Alzheimer's disease many years before patients develop dementia. It can do this because it can target beta-amyloid," says Dr. Christopher Rowe, a lead investigator for the Australian Imaging, Biomarkers and Lifestyle study of aging and professor of nuclear medicine at Austin Hospital in Melbourne, Australia.
In one of the studies presented by Rowe's team, PET was combined with an F-18 imaging agent. Subjects who showed high levels of the tracer during imaging had an 80 percent chance of developing Alzheimer's within two years, according to study findings.
Research also found that beta-amyloid plaque in the brain was not only involved in the pathology of Alzheimer's disease but also preceded mild cognitive function.
"For those with mild memory problems who had a positive scan, 66 percent of these people progressed to dementia over three years. This compares to only 7 percent of those with a negative scan," says Rowe.
Rowe highlighted findings on this study at the meeting, which included 194 healthy elderly subjects, 92 subjects with mild cognitive impairment, and 70 subjects with Alzheimer's. C-11 Pittsburgh compound B (PiB) combined with PET was used to gauge amyloid burden in the brain.
"This is an opportunity to find the patient who has Alzheimer's and intervene with treatments as they become available," says Rowe.
He pointed out that being able to correctly identify which patients have Alzheimer's and which don't is a necessary stepping stone for developing potential drugs and therapies to treat the disease.
Alzheimer's can only be detected in a patient after death-- by studying postmortem brain samples with beta-amyloid plaque.
Currently, no reliable treatment exists for Alzheimer's patients and the screening tests that do exist are unreliable and limited in their ability to identify the disease early.
New biomarkers emerge
Any PET amyloid imaging test must begin with a biomarker. This year's SNM meeting presented some promising amyloid imaging agents in development that will help clinicians detect Alzheimer's in living patients.
GE Healthcare's Flutemetamol 18F is a PET imaging agent in development for the detection of beta-amyloid plaque. Data from studies presented at the meeting not only show that this agent correlates with beta-amyloid through in vivo biopsy using PET technology, but data also shows that it can be measured in patients who do not exhibit symptoms of the disease yet.
"Flutemetamol has completed phase III trials and our filing with the FDA is imminent," says a GE spokesperson.
Study findings presented on a late-stage imaging agent from Piramal Imaging, recently formed through the acquisition of worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG, added to this collection of beta-amyloid biomarker research.
Dr. Ludger Dinkelborg, CEO and co-founder of Piramal, spoke about a phase III trial of his company's leading compound, florbetaben, for beta-amyloid PET imaging on six different regions of the brain. The study is unique, not only because it looks at different regions of the brain, but also because it incorporates MRI screening.
"Because PET doesn't have a high spatial resolution, we combined this study with an MRI," says Dinkelborg.
Regional MRI-PET co-registered data were analyzed by three independent blinded readers.
"We now have data on all the regions of the brain and data on histochemistry showing: is the protein [amyloid] there? How much of the protein is there? And in the six regions are there differences?" says Dinkelborg.
The Siemens solution
Siemens Healthcare announced a first-time integrated amyloid imaging solution for detecting Alzheimer's disease.
"We want to provide it as a package to assist in the evaluation of Alzheimer's and other cognitive decline," says Alexander Zimmermann, vice president of marketing and sales for Siemens molecular imaging division.
PETNET Solutions, a Siemens subsidiary, entered a deal last November with Eli Lilly & Company to manufacture and distribute Amyvid, an amyloid imaging agent approved by the FDA in April. Currently, Siemens PETNET Solutions has nine amyloid imaging manufacturing facilities across the country. Because PET biomarkers have short half-lives, this will expand to 16 more manufacturing centers by the end of year to ensure greater access to the biomarker. To reduce production complexity, Siemens has standardized its equipment across the centers and specially trained its technicians to improve the process.
"You can now say with certainty to a business that it will be there at 9 a.m. Monday morning," says Zimmermann.
The new integrated solution also includes the Siemens Biograph mCT scanner, the new PET/CT system that incorporates reproducible quantification, as well as syngo.PET Amyloid Plaque quantification software, which just received FDA 510(k) clearance this week.
More efforts are underway
Alzheimer's disease affects an estimated 18 million people worldwide. It's projected to double to 34 million by 2025, according to the World Health Organization. Another concern is the global financial impact of the disease. In 2010, it was estimated that Alzheimer's cost the world more than $604 billion, and that figure is only expected to rise.
Although research into the pathology of the disease has advanced in recent years, as seen by what was on display at SNM 2012 to image beta-amyloid plague in the brain, there is still a significant amount of work to be done. In recognition of this, the U.S. government launched the National Alzheimer's Plan in May, which will funnel $156 million into finding effective ways to prevent and treat the disease by 2025.