U.K. researchers from academia and industry say they've taken a big step forward in developing a viable Alzheimer's blood test. The advancement includes the discovery of 10 protein biomarkers in the blood that may help predict the onset of the neurodegenerative disease.
The research was conducted at King's College London and Proteome Sciences, a U.K. life sciences company. If further research validates their initial results, this may be a big step forward in Alzheimer's Diagnostics and development of viable treatments for the disease. The detailed results were published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association.
FierceBiotech recently reported that Cleveland Clinic researchers found R&D work for Alzheimer's treatments has a clinical trial failure rate of 99.6%, based on a review of trial data from 2002 to 2012. It's an understatement to call that a discouraging statistic. Still, this new Alzheimer's biomarker finding might help move along the difficult Alzheimer's research process. Many believe Alzheimer's drugs have failed because they attack the disease when it is too far advanced. The King's College/Proteome Sciences study exists under a different idea: developing a diagnostic test that could catch Alzheimer's much earlier than is currently possible now, even before symptoms appear. They believe they could produce a blood test based on their biomarker finding that would simplify the process of spotting the disease early-on, better than other methods under consideration, such as PET brain scans and plasma in lumbar fluid. Both approaches are more expansive and invasive, respectively, the researchers said.
GE Healthcare ($GE) is among the companies that believe in the PET approach. The company has achieved U.S. approval for its imaging agent Vizamyl as a tool to help diagnose Alzheimer's disease by spoting amyloid proteins. They are close to obtaining Europe's approval as well. But reimbursement uncertainty remains, and the company has been hampered by limited approvals for use only in conjunction with other tests. Eli Lilly ($LLY) has limited U.S. approval for a similar imaging agent, but Medicare won't reimburse its use much beyond clinical trials.
If King's College/Proteome Sciences can morph their finding into a viable blood test, the hope is that drug developers would gain a tool that boosts their success in finding treatments that can stop Alzheimer's from progressing before it causes too much damage. Drug developers, however, are a long way off from knowing if they can successfully slow or stop Alzheimer's from advancing by hitting it earlier.
In the study, the group reviewed blood samples taken from 1,148 people who took part in three international studies. 476 had Alzheimer's, 220 were diagnosed with mild cognitive impairment and 452 were elderly controls (patients who didn't have any dementia).
With that sample population in hand, the team looked for 26 proteins that had been connected to Alzheimer's in the past, and a subsection of the total patient group--476 people--also had a MRI brain scan.
Those efforts identified 16 out of the 26 proteins connected to brain shrinkage in patients either with Alzheimer's or mild cognitive impairment. Further testing of those remaining proteins attempted to determine which of them could predict a patient's progression from mild cognitive impairment to full-fledged Alzheimer's disease. Ten proteins made the cut, and the test results reflected an 87% accuracy rate.
Proteome Sciences' Ian Pike, the study's co-author, framed the study results and its combination of academic and commercial researchers as "a major advance in the development of a simple blood test to identify the disease before clinical symptoms appear."
He noted in a statement that an early stage diagnosis such as this appears to offer the best window for treatment. If it ultimately works, it would be much more cost effective than brain imaging or testing of cerebrospinal fluid. He also pointed out Proteome Sciences is seeking commercial partners to develop a globally marketed diagnostic test that uses the 10 protein biomarkers. If all goes well, it would be an advance in Alzheimer's treatment in a field that has faced many setbacks. With researchers estimating that 135 million people will have dementia by 2050, a viable Alzheimer's test can't come soon enough.
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