The study, which will commence next month, will evaluate the safety and tolerability of PBT2. In addition, it will examine the drug’s mechanism of action and indicators of potential efficacy in treating Alzheimer’s disease.
Prana Biotechnology said that earlier clinical findings suggest that PBT2 may show biochemical and possibly cognitive benefit in the relatively short time frame in its phase IIa trial of mildly affected patients.
This trial forms part of Prana’s strategy to assess the behavior of PBT2 across a broad dose range, in a manner that is also consistent with the new European Medicines Agency (EMEA) regulations that permit accelerated conditional marketing approval for treatments of seriously debilitating diseases such as Alzheimer’s disease.
Results are expected to be announced in the fourth quarter of 2007.