Australian drug developer Prana Biotechnology has received approval from the Australian Austin Health Human Research Ethics Committee to begin a phase II imaging trial to evaluate its PBT2 drug for treating Alzheimer's disease.
The trial aims to measure physical changes in the brains of participants treated with PBT2 for 12 months. Another goal is to consolidate the evidence of the positive effects of PBT2 on patients' cognition that was reported in an earlier phase IIa clinical trial, according to the company.
The double-blind, placebo-controlled trial will enroll 40 patients with prodromal or mild Alzheimer's disease at three sites in Melbourne, Australia. Pittsburgh Compound B (PiB) PET scanning will be used to measure PBT2's effect on amyloid deposits in the brain, while FDG-PET will be used to measure effects on increasing brain activity.
Researchers will use a neuropsychological test battery to measure the treatment's effects on cognition, Prana said.
