After years of relying on outdated standards for evaluating new drugs for Alzheimer’s and other neurologic diseases, the FDA is finally modernizing its approach. This is good news for researchers working to develop much-needed medications for these conditions, according to STAT News.
The change has to do with the endpoints the FDA requires in clinical trials. A loose standard in place since the 1990s required clinical trials to show that a new drug for Alzheimer’s disease improved patients’ cognition and function. But that isn’t in line with our current understanding of the disease and was likely a contributing factor in the high rate of failure in Alzheimer’s trials.
Impairments in cognition — which includes memory, executive function, language, and other aspects of thinking and reasoning — are characteristic features of Alzheimer’s. Functional impairments — problems with daily tasks such as getting dressed, brushing your teeth, cooking, driving, and the like — are generally due to cognitive issues.
Under the dual-endpoint standard, the FDA asked drug developers to demonstrate benefits to cognition among Alzheimer’s patients with symptoms of dementia that were “clinically meaningful” by demonstrating improvements in function. But we can now recognize earlier stages of Alzheimer’s disease, such as mild cognitive impairment, in which patients have no issues with daily function. In this large group of patients, it’s difficult, if not impossible, to show improvements in function because their function is fine.
Read more at STAT News.