PBT2: Phase II data
Top-line data from the double-blind, Australian Phase II IMAGINE trial in 42 patients with prodromal or mild AD showed that once-daily 250 mg oral PBT2 missed the primary endpoint of reducing brain amyloid plaque levels at 1 year as measured by PiB PET imaging vs. placebo. Prana said that while there was a reduction in overall levels of the PiB PET signal in patients treated with PBT2, the results were "confounded by an atypical reduction of levels of the PiB PET signal in the placebo group." Additionally, there was no improvement with PBT2 compared to placebo on the secondary endpoints of brain metabolic activity, cognition and function. Prana said there was a trend towards preserving hippocampal brain volume in the PBT2 group. Specifically, there was less atrophy in patients treated with PBT2 compared to placebo (2.6% vs. 4%). PBT2 was well tolerated. ...