Potential of Low Dose Leuco-Methylthioninium Bis(Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer’s Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial

This Phase III clinical trial evaluated the efficacy of LMTM, a tau aggregation inhibitor, as monotherapy in patients with mild Alzheimer's disease (AD). The study involved 800 participants randomized to receive either 100 mg or 4 mg of LMTM twice daily. Prior to unblinding, the analysis plan was revised to