BETHESDA, Md.—The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium, a public-private biomedical research partnership managed by the FNIH, recently announced that it would be releasing biomarker data from a study intended to enhance clinicians’ abilities to diagnose and measure the progression of Alzheimer’s disease (AD). The study, “Use of Targeted Multiplex Proteomic Strategies to Identify CSF-Based Biomarkers in Alzheimer’s Disease,” is the second part of a two-phased effort utilizing samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) to qualify biomarkers in both blood and cerebral spinal fluid (CSF) to diagnose and monitor disease progression in Alzheimer’s patients. ADNI is the largest public-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 Biomarkers Consortium. Through the use of proteomics, researchers identified biomarkers from 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 a public domain database allowing interrogation of the relationship between a range of physiologically important proteins in blood and cerebrospinal fluid and genetic variation,” Dr. William Potter, advisor to the FNIH Biomarkers Consortium, said in a press release. “As such, it will serve not only to advance methods of AD drug development, but for any central nervous system condition of interest.”  

 

ADNI was launched in 2004 to study and identify the changes that occur in the brains of older people even before the onset of recognizable Alzheimer’s symptoms. The National Institute on Aging (NIA) at the NIH is leading the effort, through a grant to the non-profit Northern California Institute for Research and Education, with additional private sector support from corporations and organizations provided through the FNIH. Through the use of imaging and biomarkers, the study looked at older people with normal cognition, mild cognitive impairment and Alzheimer’s dementia. The FNIH and the NIA announced ADNI 2, a renewal of the project in October 2010, which will allow ADNI to continue for another five years through 2015.  

 

“One of the most important aspects of this is this is going to allow us to figure out whether or not the blood tests which are being proposed can substitute or not for the cerebral spinal fluid test,” says Potter. “Obviously, if you could prove that you could get the same or equivalent information in blood as you can in cerebral spinal fluid, that would be rather nice. It would make it a lot easier to test people. One of the big things 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 fluid which might serve some of this role” in terms of finding a way to track disease severity, though he says it is still a bit premature for that possibility.  

 

This approach, having public libraries of disease biomarker research 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 is now very familiar with this, and are looking for more and more ways to achieve the 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 multiple discussions 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, the Parkinson’s Progression Markers Initiative (PPMI), which is being led by the Michael J. Fox Foundation. The PPMI is searching for biomarkers for the progression of Parkinson’s disease.

 

“The results of the Biomarker Consortium data project should help move us closer to achieving our shared goal of identifying who is at risk for Alzheimer’s before symptoms appear and to developing the tools that will enable us to track progression of the disease,” Dr. Neil Buckholtz, of the NIA’s Division of Neuroscience and a leader ADNI’s founding, said in a press release. “Making these results available to the wider research community is important to our ultimate aim of speeding up research aimed at finding therapies to prevent, delay or treat this devastating neurodegenerative disorder.”

 

Other participating and funding organizations, besides the NIH and FDA, include Alzheimer’s Drug Discovery Foundation, Eli Lilly and Co., Janssen Alzheimer Immunotherapy Research & Development, Eisai Inc., Pfizer Inc., Merck and Co. and Takeda Global Research and Development Center Inc.