Prana Biotechnology (PRAN) Receives Approval by Austin Health Research Ethics Committee for Alzheimer's Trial
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Prana Biotechnology (NASDAQ: PRAN) today announced that it has received approval from the Austin Health Research Ethics Committee to commence a 12 month Phase II Imaging trial testing PBT2, the Company's drug in development for Alzheimer's Disease.
The purpose of the trial, which builds on the success of an earlier Phase IIa clinical trial of PBT2, is to measure physical changes in the brains of participants treated with PBT2 for 12 months, and to consolidate the evidence, over a longer period, of the positive effects of PBT2 on patients' cognition reported in the earlier trial.
"This is an important milestone for the Company. Given that PBT2 has already been shown both to significantly change Abeta levels in spinal fluid and improve the cognition of Alzheimer's Disease patients in a 12 week trial, we believe that in this 12 month trial PBT2 will establish its credentials as a safe and effective treatment for Alzheimer's Disease," commented Prana's Executive Chairman, Mr. Geoffrey Kempler.
The double blind placebo controlled trial will enroll 40 patients with prodromal or mild Alzheimer's Disease in 3 sites in Melbourne, Australia. Brain Imaging will be used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (F-FDG PET). Cognition effects will be measured by the Neuropsychological Test Battery (NTB). The protocol synopsis appears below in Appendix 1.
The purpose of the trial, which builds on the success of an earlier Phase IIa clinical trial of PBT2, is to measure physical changes in the brains of participants treated with PBT2 for 12 months, and to consolidate the evidence, over a longer period, of the positive effects of PBT2 on patients' cognition reported in the earlier trial.
"This is an important milestone for the Company. Given that PBT2 has already been shown both to significantly change Abeta levels in spinal fluid and improve the cognition of Alzheimer's Disease patients in a 12 week trial, we believe that in this 12 month trial PBT2 will establish its credentials as a safe and effective treatment for Alzheimer's Disease," commented Prana's Executive Chairman, Mr. Geoffrey Kempler.
The double blind placebo controlled trial will enroll 40 patients with prodromal or mild Alzheimer's Disease in 3 sites in Melbourne, Australia. Brain Imaging will be used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (F-FDG PET). Cognition effects will be measured by the Neuropsychological Test Battery (NTB). The protocol synopsis appears below in Appendix 1.
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