Anavex Life Sciences Corp (AVXL)

[Investor2014]

I suppose we could say something like:

Using changes in KC as a measure of sleep quality in early stage AD trials may be an indication of the transition from MCI to AD. As such sleep measured by changes in KC over the natural history period where patients on average are expected to decline from MCI to AD can be used as a biomarker to measure the effect of an AD treatment. The longer sleep continues to be normal beyond the period where the AD stage is expected to occur the better the treatment effect of the drug being tested.

The transition period from MIC to AD is something like 3 years. This paper is looking at models to predict rate of decline.

Predicting Progression from Mild Cognitive Impairment to Alzheimer's Dementia Using Clinical, MRI, and Plasma Biomarkers via Probabilistic Pattern Classification

In principle sleep could be one biomarker and serve as a surrogate endpoint in a longitudinal P4 post approval study.