A dataset analysis by researchers at Eli Lilly (NYSE:LLY) evaluating the relationship between cognitive and functional impairment in patients with mild Alzheimer's disease finds that cognitive declines predict subsequent functional deficits. The finding is consistent with current scientific theory.
The challenge for drug developers is that for potential treatments that target the underlying neuropathology of the disease, effects on function may take longer to observe in clinical trials. Currently available scales were not developed to assess subtle functional changes or treatment effects on these deficits in patients with mild Alzheimer's. There is also debate over the degree of variability in the scales globally. Lilly researchers support debate on alternative ways to measure these parameters.
In their analysis of placebo data from two clinical trials, researchers found that cognitive impairment significantly predicted functional impairment in five out of six time points. When they tested the opposite hypothesis, functional scores predicted cognitive outcomes in only one out of six time points.