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Study: Minimum dose of hydromethylthionine could slow cognitive decline in mild-to-moderate Alzheimer's
Maybe some hope???
A clinical trial was just completed this year using methylene blue as a treatment for Alzheimers and the results were disappointing. Methylene blue, which earlier was found to inhibit tau aggregation in a mouse model, did not perform well on human patients.
TauRx sponsored a trial for its reformulation of methylene blue, which they named hydromethylthionine or LMTM, and it indicated that a low dosage of 8 mg/day showed the same reductions in cognitive decline and brain atrophy as the high dosages. Surprisingly the patients taking the high dosages of 150 to 250 mg faired no better than the low dose.
The concern is that the group given the low dose was also the placebo group. The placebo group was given the low dosage so that their urine would show up as blue, same as the high dose group, so that patients would not know if they were in the high dosage group or the placebo group.
The researchers were mistaken in thinking that 8 mg per day was so low that it would not have any therapeutic affect. So it turned out that there was no real placebo group to compare with the treated group, which creates the problem of determining the trials validity.
Why didn't they divide the patients into many different groups according to dosages, which would include a low dosage group. After all, as a research scientist, you would want to find the lowest effective dose so as to reduce bad side effects. It was only by accident that they discovered that a low dose might work.
A new clinical trial for LMTM using the the lower dose will have to be launched, this time making sure the placebo group is free of the trialed drug.
It is too bad that the methylene blue trial didn't work. It would have been a cheap treatment since it has been in use for more than a century. No company could claim exclusive right through patents. Still this drug has been shown to affect tau pathology and perhaps it could be trialed as a preventive, that is, if any company or organization were willing to trial a drug that could not be patented.