Predicting differential effects of sex on therapeutic benefit and limitations in Alzheimer’s disease drug development using animal models

Using the unbiased and rigorous screening approaches of the PTC, we have identified divergent effects of sex on PK measures (including plasma and brain exposures), efficacy (e.g., amyloid lowering) and behavioral effects (including side-effects) in all compounds tested. These data in the mice were consistent with clinical data demonstrating differential effects of sex on therapeutic benefits and limitations reported for each of these compounds CONCLUSIONS: Using rigorous and unbiased screening approaches that are powered to detect effects of sex in animal models can be used to predict differential effects of sex on therapeutic benefit and limitations of novel compounds being investigated for the treatment of AD.