TRx0237 Phase III Clinical Trials in Alzheimer's Disease
https://clinicaltrials.gov/study/NCT01689246
TauRx Pharmaceuticals conducted phase III studies of TRx0237, a methylene blue derivative with enhanced pharmaceutical properties. The first study involved 891 patients with mild-to-moderate Alzheimer's disease who received either 75 mg or 125 mg twice daily, or a control dose of 4 mg TRx0237 (to maintain blinding through urine discoloration) for 15 months. While the primary analysis showed no significant impact on cognition or function, a secondary analysis focusing on patients taking the drug as monotherapy revealed significant treatment benefits2.
In a subsequent 18-month phase III trial, researchers modified their statistical analysis to compare 100 mg TRx0237 twice daily with the control dose (4 mg TRx0237 twice daily) and to examine differences between monotherapy and add-on therapy approaches. Results confirmed the previous secondary analyses: patients taking TRx0237 as monotherapy showed less decline in cognition, function, and glucose uptake compared to those receiving it as an add-on therapy. The 100 mg dose group demonstrated greater benefits than the 4 mg group, though the latter included both monotherapy and add-on therapy patients in the analysis2.