During a recent trial, a new experimental oral drug called hydromethylthionine mesylate (HMTM), designed to stop a harmful protein called tau from clumping together in the brain, showed promising results. In the third phase of the trial, known as the LUCIDITY trial, this drug significantly reduced a biological marker of Alzheimer's disease.
This marker, neurofilament light chain (NfL), is found in our blood and gives us an idea of the level of damage happening in the brain due to neurodegenerative disorders like Alzheimer's disease. The concentration of this marker decreased by an impressive 93% over 12 months in patients who were given a daily 16 mg dose of HMTM compared to the control group. Moreover, these changes in the levels of NfL were significantly connected to the changes in another marker of tau in the blood as well as alterations in the scores of cognitive tests.
"This is a major milestone. HMTM is the first of its kind - an inhibitor that stops tau proteins from clumping together - to have reached this phase of testing and shown such results," said Dr. Claude Wischik, the head of TauRx Therapeutics, the company that's developing this drug.
In Alzheimer's disease, NfL levels can indicate the severity of the condition and track the ongoing damage to brain cells. Thus, the changes we're seeing in NfL levels due to HMTM treatment suggest that this drug is having a direct impact on the disease itself.
These results were part of a predetermined analysis of blood markers in the LUCIDITY trial and were presented at the Alzheimer's Association International Conference 2023. Abstract 74962.
However, it's worth noting that during the trial, a surprise result emerged. Both the patients receiving a 16 mg/day dose of HMTM and the control group, which was given a low dose of a similar drug called methylthioninium chloride (MTC), showed improvement in their thinking abilities over 18 months. This suggests that even the MTC, which was not expected to have such an effect, had active drug levels in the blood high enough to make a clinical difference.
In conclusion, these results are encouraging but more research is needed. The decrease in the NfL marker shows that HMTM may indeed have the potential to combat Alzheimer's disease, but the unexpected positive effects seen in the control group also suggest that there's still more we need to understand about these types of treatments.
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