- LTMX tablets taken twice a day can improve brain function in people with dementia
- The drug de-tangles the tau protein plaques that form in the memory region of the brain
- LMTX might be effective as a monotherapy at a dose as low as 4mg twice every day
A drug called
LMTX could be a life-saving treatment for patients with Alzheimer's disease.
The second phase III study results for LMTX published in the Journal
of Alzheimer's Disease showed that the drug significantly improved
brain function in patients with dementia.
Second Phase III Study of LMTXA research team from the universities of Oxford and Aberdeen analyzed 800 Alzheimer's patients across 12 countries. The study investigated the efficacy and safety of LMTX in 800 patients with mild Alzheimer's disease. The patients were given LMTX at a dose of either 4mg or 100mg (control group) twice daily for a period of 18 months.
The research team tested the ability of the patients to name objects and recall items from a list of 10 and identify their name. They also assessed the patients' ability to eat and dress without help. MRI scans were taken to monitor the brain injury of the patients. The results of the second Phase III study showed that:
- The brain injuries of the patients' improved significantly after nine months.
- The MRI scans of the patients resembled those of healthy people without dementia.
- The patient's ability to complete the tasks also improved significantly.
LMTXLMTX, which is under investigation was found to improve brain injuries to the extent that the patient's MRI scans resemble those of healthy people in just nine months. The drug significantly improved the patients' ability to carry out everyday tasks, remember the date and also name objects correctly.
Professor Gordon Wilcock from the University of Oxford, lead author of the study said, "I haven't seen such brain injury recovery before after a drug treatment. However, this drug, like all drugs has side effects, the bigger the dose the more likely you are to get side effects."
"Although these results come from non-randomized cohort analyses, a number of things point to real treatment effects and not just differences between patients taking or not taking the standard treatments. The analysis showing a slow-down in the brain atrophy rate is a before-and-after analysis in which the monotherapy patients were their own controls, and so does not depend on a comparison with add-on therapy patients. We are also starting to understand the pharmacologic basis of the negative interaction between LMTX and the standard treatments since we have now seen the same thing happening in an animal model of tau protein aggregation," said Professor Wilcock.
The research team plans to conduct further studies to investigate the lower dose of LMTX.
Professor Claude Wischik from Aberdeen University and Executive Chairman of the drug's manufacturer TauRx Therapeutics, said, "Both doses were equally effective. We are taking the 4mg dose forward because it's better tolerated and has no difference in effect."
The drug will be approved only if the future trials are positive. It will probably take another five years, said Professor Wilcock.
- Gordon K. Wilcock, Serge Gauthier, Giovanni B. Frisoni, Jianping Jia, Jiri H. Hardlund, Hans J. Moebius, Peter Bentham, Karin A. Kook, Bjoern O. Schelter, Damon J. Wischik, Charles S. Davis, Roger T. Staff, Vesna Vuksanovic, Trevor Ahearn, Luc Bracoud, Kohkan Shamsi, Ken Marek, John Seibyl, Gernot Riedel, John M.D. Storey, Charles R. Harrington, Claude M. Wischik. Potential of Low Dose Leuco-Methylthioninium Bis(Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer's Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial. Journal of Alzheimer's Disease, 2017; 61 (1): 435 DOI: 10.3233/JAD-170560