BETHESDA, Md.—The Foundation for the National Institutes ofHealth (FNIH) Biomarkers Consortium, a public-private biomedical researchpartnership managed by the FNIH, recently announced that it would be releasingbiomarker data from a study intended to enhance clinicians' abilities todiagnose and measure the progression of Alzheimer's disease (AD). The study,"Use of Targeted Multiplex Proteomic Strategies to Identify CSF-BasedBiomarkers in Alzheimer's Disease," is the second part of a two-phased effortutilizing samples from the Alzheimer's Disease Neuroimaging Initiative (ADNI)to qualify biomarkers in both blood and cerebral spinal fluid (CSF) to diagnoseand monitor disease progression in Alzheimer's patients. ADNI is the largestpublic-private partnership to date in the field of Alzheimer's research.
Going public: FNIH Biomarkers Consortium to release Alzheimer’s biomarker data
One of the most important aspects of the effort is to discover whether or not proposed blood tests can substitute for cerebral spinal fluid tests
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BETHESDA, Md.—The Foundation for the National Institutes ofHealth (FNIH) Biomarkers Consortium, a public-private biomedical researchpartnership managed by the FNIH, recently announced that it would be releasingbiomarker data from a study intended to enhance clinicians' abilities todiagnose and measure the progression of Alzheimer's disease (AD). The study,"Use of Targeted Multiplex Proteomic Strategies to Identify CSF-BasedBiomarkers in Alzheimer's Disease," is the second part of a two-phased effortutilizing samples from the Alzheimer's Disease Neuroimaging Initiative (ADNI)to qualify biomarkers in both blood and cerebral spinal fluid (CSF) to diagnoseand monitor disease progression in Alzheimer's patients. ADNI is the largestpublic-private partnership to date in the field of Alzheimer's research.
The study was conducted by researchers from academia,pharmaceutical companies, the National Institutes of Health (NIH) and the U.S.Food and Drug Administration under the auspices of the FNIH BiomarkersConsortium. Through the use of proteomics, researchers identified biomarkersfrom CSF samples in ADNI's database, which is open to the global research community.Additional studies using ADNI's CSF samples are also underway.
"This set of data realizes a 15-year-old vision of having apublic domain database allowing interrogation of the relationship between arange of physiologically important proteins in blood and cerebrospinal fluidand genetic variation," Dr. William Potter, advisor to the FNIH BiomarkersConsortium, said in a press release. "As such, it will serve not only toadvance methods of AD drug development, but for any central nervous system conditionof interest."
ADNI was launched in 2004 to study and identify the changesthat occur in the brains of older people even before the onset of recognizableAlzheimer's symptoms. The National Institute on Aging (NIA) at the NIH isleading the effort, through a grant to the non-profit Northern CaliforniaInstitute for Research and Education, with additional private sector supportfrom corporations and organizations provided through the FNIH. Through the useof imaging and biomarkers, the study looked at older people with normalcognition, mild cognitive impairment and Alzheimer's dementia. The FNIH and theNIA announced ADNI 2, a renewal of the project in October 2010, which willallow ADNI to continue for another five years through 2015.
"One of the most important aspects of this is this is goingto allow us to figure out whether or not the blood tests which are beingproposed can substitute or not for the cerebral spinal fluid test," saysPotter. "Obviously, if you could prove that you could get the same orequivalent information in blood as you can in cerebral spinal fluid, that wouldbe rather nice. It would make it a lot easier to test people. One of the bigthings that will come out of this is determining whether that is possible."
Potter adds that their discoveries to date have made them"much more certain that there are real abnormalities in cerebral spinal fluidwhich might serve some of this role" in terms of finding a way to track diseaseseverity, though he says it is still a bit premature for that possibility.
This approach, having public libraries of disease biomarkerresearch available to the global research community, is one that Potter says he"definitely" sees becoming a more prevalent trend.
"Senior leadership in the scientific and research world isnow very familiar with this, and are looking for more and more ways to achievethe type of open sourcing and rapid turn-around of data and sharing of data,"Potter notes. "So this is being embraced as an idea, and there are multiplediscussions going on about how better to gather and share data."
Dr. Judith Siuciak, scientific program manager for neuroscience at the FNIH, says a similar undertaking is already underway, theParkinson's Progression Markers Initiative (PPMI), which is being led by theMichael J. Fox Foundation. The PPMI is searching for biomarkers for theprogression of Parkinson's disease.
"The results of the Biomarker Consortium data project shouldhelp move us closer to achieving our shared goal of identifying who is at riskfor Alzheimer's before symptoms appear and to developing the tools that willenable us to track progression of the disease," Dr. Neil Buckholtz, of theNIA's Division of Neuroscience and a leader ADNI's founding, said in a pressrelease. "Making these results available to the wider research community isimportant to our ultimate aim of speeding up research aimed at findingtherapies to prevent, delay or treat this devastating neurodegenerativedisorder."
Other participating and funding organizations, besides theNIH and FDA, include Alzheimer's Drug Discovery Foundation, Eli Lilly and Co.,Janssen Alzheimer Immunotherapy Research & Development, Eisai Inc., PfizerInc., Merck and Co. and Takeda Global Research and Development Center Inc.
