Takeda Pharmaceuticals and Zinfandel Pharmaceuticals say their new genetics-based Alzheimer's biomarker risk assignment algorithm generated promising results in early testing. A Phase III trial will advance the concept further, continuing a partnership between the companies formed more than two years ago.
Michael Lutz, a senior research scientist of Duke University School of Medicine's Department of Neurology, is the principal investigator in the project and he presented results at the recent Alzheimer's Association International Conference in Boston.
The gist is this: Their algorithm was able to gauge the likelihood of developing or not developing Alzheimer's within a range of 70% to 80% accuracy. That's significant because imaging and cerebrospinal fluid-based biomarkers generate similar results.
Lutz told the research gathering that they are encouraged enough that they'll be taking their biomarker risk assignment algorithm into a Phase III trial. The formula involves using age and APOE status in addition to the biomarker TOMM40 to predict the risk of mild cognitive impairment due to Alzheimer's within 5 years in older adults with normal cognition.
"Compared to only using APOE status and age as factors, the addition of TOMM40 makes this a promising biomarker risk assignment algorithm," Lutz said in a statement. "There is a tremendous need for tests to identify and predict the risk of mild cognitive impairment due to Alzheimer's disease."
The idea is that earlier diagnosis will enable sooner treatment, with the idea of slowing or stopping the progression of Alzheimer's before it creates too much cognitive damage. Takeda and Zinfandel inked their initial biomarker development deal back in January 2011.
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