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

Although HMTM 16 mg/day arrested progression of neurodegeneration and reduced grey matter atrophy at 52 weeks, symptomatic activity in the control arm precluded separation of treatment arms at 52 weeks on primary clinical endpoints. In participants with MCI, significant clinical separation was seen only at 78 and 104 weeks. This effect has been confirmed in a further study. HMTM was well tolerated and has the potential to offer an accessible oral treatment option with a benign safety profile which could be delivered with minimal patient/physician burden.

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Publication Details

Journal
The Journal of Prevention of Alzheimer s Disease
Published
2026-01-21
DOI
https://doi.org/10.1016/j.tjpad.2026.100480
Primary Topic
Biochemical effects in animals
Type
article
Field-Weighted Citation Impact
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article

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

Lewis K. Penny, Gordon Wilcock, Mohammad Arastoo, Karin Kook et al.
The Journal of Prevention of Alzheimer s Disease
Biochemical effects in animals
article

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

Lewis K. Penny, Gordon Wilcock, Mohammad Arastoo, Karin Kook, Emer MacSweeney, Richard G. Stefanacci, Clive Ballard, Emily C. Evans, Peter Bentham, Natalia Muehlemann, Nafeesa Nazlee, Helen Shiells, Carol A. Pringle, John M. D. Storey, Claire Hull, Tay Siew Choon, Alistair Burns, B. Schelter, Tom Baddeley, Charles R Harrington, Jan Priel, Tenecia Sullivan, Serge Gauthier, Claude M Wischik, Jin-Tai Yu, Roger Staff, Henrik Zetterberg, Sonya Miller, Serena Lo, Diane Downie, Vahe Asvatourian
article en

Abstract

Although HMTM 16 mg/day arrested progression of neurodegeneration and reduced grey matter atrophy at 52 weeks, symptomatic activity in the control arm precluded separation of treatment arms at 52 weeks on primary clinical endpoints. In participants with MCI, significant clinical separation was seen only at 78 and 104 weeks. This effect has been confirmed in a further study. HMTM was well tolerated and has the potential to offer an accessible oral treatment option with a benign safety profile which could be delivered with minimal patient/physician burden.

The Journal of Prevention of Alzheimer s DiseaseVol. 13(3)
Thomas Jefferson University (US), University of Aberdeen (GB), Heidelberg University (DE), University of Exeter (GB), Fudan University (CN), Aberdeen Royal Infirmary (GB), Sahlgrenska University Hospital (SE), Birmingham and Solihull Mental Health NHS Foundation Trust (GB), University Hospital Heidelberg (DE), University of Manchester (GB), University of Oxford (GB), Central Institute of Mental Health (DE), Cambridge Cognition (United Kingdom) (GB), Huashan Hospital (CN), TauRx (United Kingdom) (GB), University College London (GB), McGill University (CA), Cytel (United States) (US)
Good health and well-being
Openalex Percentile: Top 80%
Biochemical effects in animals
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