So far, the independent data safety monitoring board has reviewed blinded data of over 50 patients; there have been no treatment-related serious adverse events or withdrawals, and the trial has now been confirmed safe to continue as per the original protocol.
In total, 55 patients (or approximately 70% of the planned 80 patients) have been randomized, 30 patients have completed dosing, and as planned, patient dosing is expected to be completed by the end of 2007.
This Phase IIa trial is a double-blind, placebo-controlled safety and tolerability study of PBT2 in patients with mild forms of Alzheimer’s disease. PBT2 is Prana’s proprietary lead compound.
In addition, the trial is investigating the effect of PBT2 on multiple cerebrospinal fluid (CSF) and blood biomarkers that have been directly associated with the etiology of Alzheimer’s disease. Outcomes will include measures of CSF A-beta and tau levels, as well as neurocognitive and behavioral changes.