LUCIDITY Clinical Trial Demonstrates Reduction of Plasma Biomarker Neurofilament Light Chain in Alzheimer Disease Participants

Results from the LUCIDITY clinical trial (NCT03446001) measuring the efficacy of hydromethylthionine mesylate (HMTM; TauRx, Singapore, Singapore) treatment for individuals with mild to moderate Alzheimer disease (AD) revealed a dose-dependent reduction in plasma neurofilament light chain (NfL) levels. These results were presented at the 2023 meeting of the Alzheimer’s Association International Conference (AAIC) in Amsterdam, The Netherlands. HMTM is a tau aggregation inhibitor.

The phase 3, double-blind, randomized, placebo-controlled clinical trial included an initial 12 month period in which participants received orally administered HMTM 16 mg/day, HMTM 8 mg/day, or methylthioninium chloride (MTC) given twice weekly as a control, followed by an additional 12 month blinded, open-label extension during which time all participants received HMTM 16 mg/day. Prespecified analysis showed a 93% reduction in the change in NfL levels relative to control for HMTM 16 mg/day overall (P=.0278). Subgroup analysis of data from participants with AD and mild cognitive impairment due to AD (MCI-AD) showed a significant reduction in the MCI-AD subgroup change in NfL levels at HMTM 8 mg/day (P=.0242) and a directional dose-dependent trend for the AD subgroup that did not reach statistical significance.

As Claude Wischik, Executive Chairman of TauRx notes, these results “bring us a step closer to offering an effective new treatment option for people with AD. Because it is taken as a tablet and has a strong safety profile, HMTM would be readily accessible to people needing a disease modifying treatment.” Researchers who are part of this study represent a variety of institutions, including TauRx Therapeutics Ltd., the University of Aberdeen, UCL Queen Square Institute of Neurology, and the University of Gothenburg.