Update to Toyama's drug. Failed again in an even larger trial unfortunately. Notice they TOO allowed donezepil patients to participate.
In March 2014, the North American consortium Alzheimer's Disease Cooperative Study (ADCS) started another one-year, Phase 2 study of T-817MA called Noble. It compared 224 mg to 448 mg of T-817MA once daily and to placebo. It enrolled 484 patients with mild to moderate Alzheimer's disease who were already taking donepezil, or donepezil and memantine. This study used the ADAS-cog and ADCS-CGIC as primary outcome, and safety as well as ADCS-ADL, FAQ, NPI and MMSE as secondary outcomes. Unlike most ADCS trials, this study received no federal funding but was fully sponsored by Toyama. This trial was completed in May 2017.
On July 19, 2017, Fujifilm Corporation announced that the Noble trial failed to reach primary endpoint, and that there were no differences between the groups on secondary endpoints. According to the press release, exploratory analyses spotted biomarker signals in CSF p-tau levels and hippocampal volume, and post-hoc analyses hinted at a possible subgroup effect on cognition. Fujifilm announced its intention to continue developing T-817MA (see company press release). In November 2017, results presented at CTAD confirmed that Edonerpic had failed to outperform placebo on the primary or any of the secondary outcomes. Some biomarkers showed changes, but the changes did not all trend in the same direction. Dropouts in the placebo, low and high dose were 11.4, 29.5 and 24.1 percent, respectively (see Dec 2017 conference news).
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