The trial was designed to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil in patients with mild Alzheimer’s disease and the company announced initial findings on December 18, 2007.
As a result of errors made in the transcription of data and calculation of the Alzheimer’s disease assessment scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021). Data for the patients on a 50mg dose of PRX-03140 showed a one point improvement on the ADAS-cog. The monotherapy dose response (150mg versus 50mg versus placebo) continues to be statistically significant with p=0.026. There were no substantive changes in the results from the combination arms of the study.
In the Phase IIa clinical trial, PRX-03140 appeared to be well tolerated, both alone and in combination with donepezil (Aricept). No serious drug-related adverse events occurred during the trial. The two-week study also utilized other cognitive tests including Mindstreams, an automated battery of computerized cognitive function tests. Patients on monotherapy demonstrated significant (p<0.04) improvements in memory and visual-spatial indices as measured using Mindstreams when compared with placebo. Michael Kauffman, CEO of Epix, said: "With our partner, GlaxoSmithKline, we are continuing with our plans to initiate a Phase IIb clinical trial program in Alzheimer's patients in the first half of 2008."