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July 17, 2014 /PRNewswire/ -- Prana Biotechnology (NASDAQ: PRAN; ASX: PBT) has today provided an update on its clinical development program for Alzheimer's disease.
Colin Masters, the Florey Institute of Neuroscience and Mental Health, The
University of Melbourne, will today include data from Prana's Phase 2 IMAGINE and EURO trials in his presentation at the Alzheimer's Association International Conference in
The presentation is entitled:
"How to change and monitor the rates of ABeta amyloid accumulation and cognitive decline in Alzheimer's disease". The presentation can be viewed here:
AAIC Panel Presentation_Colin Masters
The IMAGINE trial top-line draft results were released on
31 March 2014. Further sub-analyses of the top line imaging data have been performed, including PiB-PET, MRI and FDG analysis of the effects of a once daily, 250 mg dose of PBT2 over 12 months. IMAGINE enrolled 42 patients, 27 in the PBT2 group and 15 in placebo.
The primary objective of the IMAGINE trial was to explore whether amyloid burden, as measured by PiB-PET would decrease in participants treated with PBT2 relative to placebo. However, in contrast to published literature, the average amyloid burden in the placebo group fell during the trial.
Prana conducted a sub-analysis to better understand the behaviour of the placebo group and what can be learned in the trial about the utility of such exploratory biomarkers for future trials.
In Professor Masters' presentation, he noted that the starting amyloid burden level (baseline) in the PBT2 treated participant group had an important bearing on the decrease of amyloid over time in that participant (p=0.035), whereas there was no such correlation in the placebo group.
Prof Masters further investigated the response of participants with baseline amyloid burden levels above and below the mean for the IMAGINE cohort (SUVR of 2.5). He showed that in the subgroup of PBT2 treated participants with a baseline of SUVR above 2.5, there was a significant decrease in amyloid burden that was not observed in participants on placebo nor PBT2 participants with a SUVR less than 2.5. In summary, whilst the utility of PiB in small trials may be questioned, it was interesting to note the impact of baseline SUVR amyloid burden level on the response of a cohort, for future trial design.