Prana Biotechnology has obtained approval from Austin Health Human Research Ethics Committee (HREC) to intiate a 12-month open-label, non-randomised, extension study of the PBT2-204 IMAGINE Study in patients with Alzheimer's disease.
About 15% of participants in IMAGINE study have completed the full 12-month treatment period, whereas 100% completed a minimum of six month treatment.
Patients completing full treatment term are eligible for open-label extension study, where they will be administered with a 250mg oral dose of PBT2 once each day for more 12 months.
Prana chairman and CEO Geoffrey Kempler said the IMAGINE trial will reveal the effects of PBT2 over 12 month period.
"This will allow us to take the steps necessary to progress the commercialisation of PBT2 for Alzheimer's," Kempler added.
"What is so helpful about the open-label study is that it will provide ongoing information to support the safety, tolerability and efficacy of PBT2 over a 24-month period."
Similar to the IMAGINE protocol, the open-label extension study protocol measures amyloid burden and physical changes uisng PET imaging, MRI and FDG-PET, in addition to cognition and function in the brains of Alzheimer's patients.
The results from the study are expected in March 2014.
