Phase II Trial of Methylene Blue in Alzheimer's Disease

Phase II Trial of Methylene Blue in Alzheimer's Disease

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5209349/

This 24-week phase II clinical trial involved 321 patients with mild-to-moderate Alzheimer's disease who were not taking acetylcholinesterase inhibitors or memantine. For patients with moderate Alzheimer's, a nominal dose of 138 mg/day (administered as 60 mg tablets three times daily) improved cognition significantly, with ADAS-cog scores dropping by 1 point from baseline, representing a 5.42-point improvement compared to placebo2.

Improvements were also observed in ADCS-CGIC and MMSE scores relative to placebo and baseline measurements. Patients with mild Alzheimer's showed improvements in cerebral blood flow despite lacking cognitive benefits. Importantly, the cognitive benefits persisted throughout a 50-week extension period, though interestingly, the higher nominal dose of 228 mg/day did not demonstrate benefits, suggesting a specific therapeutic window for methylene blue in Alzheimer's disease2.