Prana Biotechnology (PRAN: Quote, PBT.AX) announced that it has received approval from the Austin Health Human Research Ethics Committee or HREC to commence a 12-month open-label extension study with Alzheimer's Disease patients participating in Prana's IMAGINE trial.
The approval follows a full review by Austin Health HREC of the potential benefit to patients and safety data collected during the ongoing IMAGINE trial, a 12-month double-blind Phase II clinical trial of PBT2 in Alzheimer's patients. Fifteen percent of participants in IMAGINE have now finished the full 12 months of treatment and one hundred percent have completed at least 6 months of treatment.
The company said that the Patients who have completed the full 12-month term of the IMAGINE trial are eligible for participation in the open-label extension study. All participants in the extension study will receive a 250mg once daily oral dose of PBT2 for an additional 12 months, with the first patient expected to start next month.
The company noted that the open-label extension study protocol will closely follow the IMAGINE protocol, measuring amyloid burden and physical changes in the brains of Alzheimer's patients, through PET imaging, MRI and FDG-PET, as well as cognition and function.
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by RTT Staff Writer
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