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In a recent report by Geert De Meyer of Ghent University in Belgium and colleagues, titled “Diagnosis-Independent Alzheimer Disease Biomarker Signature in Cognitively Normal Elderly People” (Arch Neurol. 2010;67(8):949-956) it was demonstrated that measuring certain proteins in spinal fluid can accurately diagnose Alzheimer’s and predict which patients with memory problems will develop the fatal brain-wasting disease. In addition, the measuring of these proteins may also help identify early signs of the disease in healthy people, the team reported. The team concluded “The unexpected presence of the AD signature in more than one-third of cognitively normal subjects suggests that AD pathology is active and detectable earlier than has heretofore been envisioned.”
The study is the latest to show that measuring disease-related proteins in spinal fluid is useful in diagnosing Alzheimer’s disease. Up to now, only an autopsy could confirm that a person has Alzheimer’s, a fatal and incurable deterioration of the brain that affects more than 26 million people globally. Doctors diagnose Alzheimer’s by excluding other causes of memory loss, such as stroke, tumors and heavy drinking. They can also administer simple paper-and-pencil tests. But biomarkers — proteins and imaging techniques — are helping to identify the disease much earlier.
These very promising findings correlate well with findings by other scientists that recently made significant steps forward in developing a test to help diagnose the early stages of Alzheimer’s disease sooner and more accurately by measuring two biomarkers—tau and beta-amyloid proteins—in cerebrospinal fluid. This report by researchers from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) not only confirmed that certain changes in biomarker levels in cerebrospinal fluid may signal the onset of mild Alzheimer’s, but also established a method and standard of testing for these biomarkers. These are the first cerebrospinal fluid biomarker findings to be reported by ADNI, a $60-million, five-year research program launched in 2004 to observe and track changes in some 800 older people in the United States and Canada with normal cognition, mild cognitive impairment (MCI)—a condition that often precedes Alzheimer’s—or the early stages of Alzheimer’s.
“Research indicates that Alzheimer’s pathology causes changes in the brain some 10 to 20 years before any symptoms appear,” said National Institute on Aging (NIA) Director Richard J. Hodes, M.D. “This work gives researchers a systematic and reliable method to measure changes in cerebrospinal fluid biomarkers that may herald the onset of Alzheimer’s disease. More research is needed to validate these findings, but this study takes us one step closer to providing researchers and clinicians with tools to detect and understand the very early signs of the disease.”
What is more important is that this effort may open the door to the discovery of an entire panel of cerebrospinal fluid biomarkers that will not only predict those at risk of developing Alzheimer’s disease, but also reveal how the disease is responding to therapies,” said Neil Buckholtz, Ph.D., of the NIA Division of Neuroscience.
In addition, in July this year, experts at the National Institute on Aging and the Alzheimer’s Association proposed new guidelines for diagnosing Alzheimer’s even before patients have symptoms. These proposed rules summaries the significant advances in Alzheimer research since 1984, including measurements of cerebral-spinal fluid and the detection of different protein biomarkers.
These new reports and guidelines are very important steps forward both for early diagnosis and the ability to follow disease progression. By using these and other methods in development, the effect by new (and old) treatments for Alzheimer can be evaluated faster and more precise. They will all be useful tools in drug development and clinical trials and hopefully speed up the process of identifying effective and safe treatments for the aging population.
The yet bigger picture contains a convergence of genomics and medicine and as was seen at the 2010 BIO Conference in Chicago, there were ten “Breakout Sessions on Biomarkers” encompassing Intellectual Property, commercialization, reimbursement, drug development and diagnostics. All these recent advances in biomarker discovery, biocomputing and nanotechnology have raised new opportunities in the emerging fields of personalized medicine (in which disease detection, diagnosis and therapy are tailored to each individual’s molecular profile) and predictive medicine (in which genetic and molecular information is used to predict disease development, progression and clinical outcome). Therefore, it is felt that this bio-nano-info convergence holds great promise for molecular diagnosis and individualized therapy not only for Alzheimer’s Disease but also for cancer and other human diseases and we believe that many new exciting discoveries will emerge soon.
This is a post by Erik Berglund, M.D., Ph.D. Erik is a Senior Regulatory Scientist and the Associate Managing Director of Cato Research‘s San Francisco, CA office.
Related articles:
- Spinal Fluid Test May Diagnose Alzheimer’s (webmd.com)
- ‘Biomarkers’ Could Spot Alzheimer’s Disease Early, Studies Suggest (nlm.nih.gov)
- Spinal fluid proteins can help diagnose Alzheimer’s (reuters.com)
- Spinal Fluid Proteins Can Help Diagnose Alzheimer’s (nlm.nih.gov)
