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news.Prana Biotechnology plans to move forward with a phase IIa clinical trial of its proprietary lead compound, PBT2, in patients with Alzheimer's disease.
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The study, to be conducted in several sites in Sweden, will evaluate the safety and tolerability of PBT2, as well as measures of the drug’s mechanism of action and indicators of potential efficacy in Alzheimer’s disease.
The study is expected to commence enrollment in the fourth quarter of 2006, subject to final regulatory approval. Results are expected to be reported by the end of 2007.
The phase IIa study is a randomized, double-blind, placebo-controlled design, in which Alzheimer’s disease patients will receive three months of either one of three oral doses of PBT2, or placebo.
In addition to examining safety and tolerability, the study will investigate the ability of PBT2 to affect multiple cerebrospinal fluid (CSF) and blood biomarkers of Alzheimer’s disease during the treatment period. Outcomes will include measures of CSF a- beta and tau levels as well as neurocognitive and behavioral changes.
“The earlier clinical finding with PBT1, together with our data that there is a rapid and potent onset of benefits in transgenic mice treated with PBT2, leads us to believe that we may see biochemical, and possibly cognitive, benefit in the relatively short time frame of our phase IIa trial of mildly affected patients,” stated Professor Colin Masters director of Prana.