Prana Biotechnology (NASDAQ: PRAN) (ASX: PBT) announced that it is finalising plans to commence a definitive Phase IIb trial of its lead Alzheimer's disease drug, PBT2, before the end of this year.

The Phase IIb trial will involve 525 patients with mild to moderate Alzheimer's disease. Treatment will be over a period of 12 months, with the key performance measure being cognition (including ADAS Cog* and Executive Function tests from the NTB*). The trial, a double blind placebo controlled study, will test the efficacy of 2 doses of PBT2 (250mg and 100mg). "We are excited by this protocol because we already know how patients benefited from a 250mg dose of PBT2 in just 12 weeks, so we are confident the benefit will be even stronger and more pronounced over a 12 month trial," said Mr. Kempler. "This trial is all about cognition and helping patients."

"Over recent years most drug companies have made late stage drug development decisions based on secondary biomarkers and imaging. Certainly, many have seen amyloid signals, but not necessarily robust cognition outcomes. PBT2 has shown both positive cognitive and biomarker changes, which is why we are so optimistic in the ability of PBT2 to really help sufferers of Alzheimer's disease."

The Company has prepared an explanation of its understanding of how PBT2 works in the brains of patients with Alzheimer's disease and in particular how PBT2 is uniquely different to other approaches for treating the disease. The explanation, in the form of a Mechanism of Action Position Statement, will be available on the Prana website next week.

"The landscape has changed. Patients need and deserve a therapeutic solution based on strong science as well as clinical trials that translate the science into real benefits for patients. We believe that PBT2 will achieve this," concluded Mr. Kempler.

Discussions with potential sources of finance for the upcoming trial, both with investors and pharmaceutical partners, are progressing well and we will keep our shareholders updated.

* ADAS-Cog (Alzheimer's Disease Assessment Scale - cognitive subset) and NTB (Neuropsychological Test Battery) are tests given to Alzheimer's disease patients to measure changes in memory and Executive Function.