Clinical, imaging and blood biomarker outcomes in a Phase 3 clinical trial of tau aggregation inhibitor hydromethylthionine mesylate in mild cognitive impairment and mild to moderate dementia due to Alzheimer’s disease

Key Points

• This research aims to evaluate the clinical, imaging, and biomarker outcomes of hydromethylthionine mesylate in subjects with mild cognitive impairment and dementia associated with Alzheimer's disease.
• Conducted a Phase 3 clinical trial
• Administered hydromethylthionine mesylate at a dosage of 16 mg/day
• Monitored clinical endpoints and imaging outcomes over 52 weeks
• Assessed safety and tolerability of the treatment
• HMTM halted neurodegeneration and decreased grey matter atrophy by 52 weeks
• Significant clinical separation in mild cognitive impairment was observed at 78 and 104 weeks
• The control arm’s symptomatic activity affected outcomes at 52 weeks
• HMTM demonstrated a benign safety profile and was well tolerated