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.

ABSTRACT:

Background

Hydromethylthionine mesylate (HMTM) targets tau pathology and has tau-independent symptomatic activity.

Objectives

To evaluate the safety and efficacy of HMTM in participants with mild cognitive impairment (MCI) and mild to moderate dementia due to Alzheimer's disease (AD).

Setting

82 centres in Canada, European Union, United Kingdom and United States of America.

Participants

A total of 598 amyloid β-PET positive participants were included; 44% (263) met clinical criteria for MCI due to Alzheimer's disease and 56% (335) were diagnosed with mild to moderate dementia due to AD.

Intervention

HMTM 16 mg/day and 8 mg/day were compared with methylthioninium chloride (MTC) 4 mg twice weekly, intended as an inactive urinary colourant to preserve blind

SUBMITTER: Wischik CM 

PROVIDER: S-EPMC12861207 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature