Not only is the attrition rate for Alzheimer's disease therapeutics notoriously high, but also any company hoping to bring a drug to market faces a further layer of uncertainty: how open will the FDA be to new ways of proving efficacy for drug candidates? In March, Russell Katz, director of the agency's neurology products division told a meeting of the coalition to Accelerate Cure/Treatments for Alzheimer's Disease that Alzheimer's disease Assessment Scale cognitive subscale (ADAS-cog), long the standard in Alzheimer's disease measures, might not be required to prove a therapy works. He said the same about the Clinician's Interview-Based Impression of Change plus caregiver interview, another common gauge. Some had worried that the FDA might look less fondly on such tests as the Neuropsychological Test Battery (NTB), but Katz's remarks seemed to indicate the bar may be lowered, or criteria at least potentially relaxed.
Much talk at the meeting—which brought Alzheimer's disease researchers “one of our few documented insights” from the FDA, analyst Brian McCarthy with Merriman Curhan Ford in New York says—had to do with the bottom-line demand for showing improvements in global functions, such as those covered by the Disability Assessment for Dementia scale and Clinical Dementia Rating Sum of Boxes (CDR-SB), as well as boosts in cognitive abilities, such as those measured by NTB and ADAS-cog. “You can make somebody an Einstein, but if you haven't improved the global-function score, the FDA isn't going to be interested,” he says.
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