Presenter of 1 Presentation
POSITIVE CLINICAL OUTCOMES OF POSIPHEN IN TWO PHASE 2A STUDIES -- ALZHEIMER'S DISEASE AND PARKINSON'S DISEASE
Abstract
Aims
Posiphen has been shown in animal models to reduce multiple neurotoxic proteins, restore axonal transport, lower inflammation and protect nerve cells from dying. To show that Posiphen reverses the toxic cascade and potentially shows efficacy in humans, we started two double-blind, placebo- controlled clinical phase 2a studies in AD and PD patients.
Methods
In the first part, we enrolled 14 AD and 14 PD patients (4 placebo and 10 treated with 80 mg posiphen QD for 25 +/- 2 days). We measured markers of neurotoxic proteins, axonal transport, inflammation and neurodegeneration. The second part enrolled an additional 40 PD patients with the same study design to test biomarkers and efficacy at different concentrations of posiphen.
Results
From the first part of the study, we report statistically significant improvements in ADAS-Cog 11 and WAIS coding in treated AD patients comparing to baseline. Posiphen reduced sAPPα, sAPPβ, Tau, p-Tau and improved the Ab42/40 ratio. In PD patients, we see statistically significant improvements in the WAIS coding test comparing to control and strong trends in all 4 UPDRS parts. Posiphen significantly reduced inflammation in treated patients.
We expect to finish analyzing all the remaining biomarkers of part 1 and report on the part 2 data mid October.
Conclusions
In conclusion, our data from the first 28 patients shows that Posiphen improves cognition in AD and motor function in PD as well as reverses the toxic cascade. The expected additional markers and the new part 2 data will solidify and confirm that Posiphen works in AD and PD patients.