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Tuesday, October 06, 2015 10:29:18 PM
EF improvement was seen in the 2A trial for AD as well as the REACH2HD trial is not by chance. In fact statistically it is nearly impossible to achieve this type of error by chance.
Rudy Tanzi talked about this in the post trial conference call and a reference is made to this in the post-trial press- "Given the evidence from an earlier trial that showed that PBT2 improved executive function in Alzheimer’s disease patients, the Reach2HD trial included a plan to assess the effects of PBT2 on an Executive Function composite z-score that included the Trail Making Test Part B. There was a statistically significant improvement in this z-score (p=0.038) in a pre-specified analysis of Reach2HD participants with early stage Huntington disease, as measured by their Total Functioning Capacity. Across all participants, which comprised both early and mid-stage patients, there was a trend to improvement (p=0.069). "
We don't know the results of the IMAGINE trial cognition yet - if any signal was seen at all - but with a placebo group of 12 the chance of random error was very high. That trial was designed as a biomarker trial to test whether amyloid plaques could be reduced with PBT2 at 250 mg. And plaques were removed and Rudy Tanzi repeated this in his 3D model at a rate of 5-fold reduction.
PBT2 is disease modifying in AD and HD.
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