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Aug 16, 2010
 |  BioCentury  |  Product Development

ADding up biomarkers

New Alzheimer's guidelines: Practical applications are in drug development

While new Alzheimer's Association guidelines someday may affect early treatment decisions, drug developers already are identifying more immediate applications for use of brain imaging and cerebrospinal fluid testing to create and test new therapies.

The guidelines describe the use of imaging and cerebrospinal fluid (CSF) to detect AD before clinical signs of the disease appear. As reported by the general media, the guidelines pertain to the diagnosis of patients, which was buttressed last week by an opinion piece in Archives of Neurology.

But the techniques cannot yet really be used to make treatment decisions. Rather, the recommendations are intended to help drug developers select patients and monitor the efficacy of experimental therapies. Indeed, researchers are already using the diagnostic techniques to test hypotheses about the sequence of events in the progression of Alzheimer's.

Three white paper reports by committees of the Alzheimer's Association present a roadmap for interpreting molecular biomarkers for two conditions that precede AD: mild cognitive impairment (MCI) and an even earlier condition termed preclinical AD.

Drawing on a decade of animal and observational studies, the committees recommended brain imaging and monitoring AD-associated proteins in the brain and CSF as part of a diagnostic workup of patients suspected to have early stage disease.

The three reports, from separate committees of researchers from medical and academic institutions, Bristol-Myers Squibb Co. and Eli Lilly and Co., were presented at the Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) in Hawaii last month.

In their Archives of Neurology comment last week, A. Zara Herskovitz and John Growdon wrote that there is "now ample evidence that these measurements have value; physicians need to formulate when and how to incorporate CSF measurements into their practice."

Thus, the authors wrote, "we strongly recommend CSF analyses of A1-42, T-tau, and P-tau in circumstances where having a definitive diagnosis of AD is important for counseling patients about such concerns as work, driving, and making other lifestyle changes."

Herskovits is a clinical fellow in the Department of Pathology at Brigham and Women's Hospital. Growdon is founding director of the Massachusetts Alzheimer's Disease Research Center, and professor of neurology at Harvard Medical School.

Beyond these limited physician...

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