Initiative Could Transform Alzheimer's Research
Sullivan, Michele G., Clinical Psychiatry News
A $60 million, 6-year study is being launched to find and validate biologic and imaging markers that could be used as objective measures of therapeutic response in Alzheimer's disease.
The results of the Alzheimer's Disease Neuroimaging Initiative (ADNI) could dramatically shorten clinical trials of potential therapies by sidestepping the years of cognitive testing now necessary to determine a drug effects, according to experts interviewed for this article.
The time is ripe for an objective biologic marker of disease progression. Several potentially disease-modifying drugs are in phase II trials, with cognitive measures the only validated treatment outcomes. Relying solely on cognition to determine treatment effect is problematic in many ways, said Dr. Michael W Weiner, ADNI's principal investigator and the director of the Veterans Administration's Center for Imaging of Neurodegenerative Disease, San Francisco.
Everyone with AD declines, but they don't do so in a linear fashion, Dr. Weiner said "There is a lot of variability in these kinds of measures. One day, a patient might do well, and the next, do poorly depending on his general health, emotional status, or a number of other factors. This variability really affects the ability to determine a true treatment effect."
Nor, using cognitive outcomes alone, is it possible to distinguish between a drug's effects on disease progression and any memory-enhancing effects it also might exhibit, he said.
A validated biomarker, on the other hand, could show a drug's true effect, with profound influence on drug development, said Dr. John Q. Trojanowski, director of the Alzheimer's Disease Center at …
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Publication information: Article title: Initiative Could Transform Alzheimer's Research. Contributors: Sullivan, Michele G. - Author. Magazine title: Clinical Psychiatry News. Volume: 36. Issue: 3 Publication date: March 2008. Page number: 40. © 2009 International Medical News Group. COPYRIGHT 2008 Gale Group.
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