Optimizing drug development for the next generation of Alzheimer's diseasecompounds

The development of compounds capable of altering the course of Alzheimer's disease (AD) progression presents a significant challenge to clinical trial methodology. In order to maximize the potential to identify effective new therapies of this kind, appropriate doses and dosing regimens must be deter mined as early in development as possible. As patients often differ from he althy volunteers in their tolerance of CNS compounds. bridging studies can be conducted to determine the maximum tolerated dose (MTD) of an investigat ional drug in the target patient population prior to designing Phase II eff icacy trials. However, many of the newer generation compounds may be extrem ely well tolerated, thus prompting the need for other methods to identify a potentially effective clinical dose range. Dynabridge studies, dr early ph armacokinetic/pharmacodynamic (PW PD) studies, can be performed to evaluate the central pharmacological activity of the compound, identify potentially effective doses, and optimize the dosing regimen.