Highlights:- 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 LMTX
A 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.
The side effects
of the drug were gastrointestinal and urinary related, which caused 40 patients
to discontinue the treatment.
LMTX
LMTX, 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.
‘The LMTX drug significantly improved the patients' ability to carry out everyday tasks, remember the date and also name objects correctly.’
De-tangling the
plaques and preventing the formation of new plaques may slow or halt memory
loss in Alzheimer's patients. According to the LMTX manufacturer, TauRX
Pharmaceuticals, the drug contains a chemical that dissolves protein tangles
that form plaques in the memory region of the brain.
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.
Reference:- 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
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