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Improved protection against cognitive decline and Alzheimer's?
Even very low doses of a special drug seem to effectively protect against cognitive decline. This could significantly improve the treatment of Alzheimer's in the future.
In the current study by TauRx Therapeutics Ltd. It has been found that the medicine hydromethylthionine can protect people from cognitive decline. The results of the study were published in the English-language journal "Journal of Alzheimer's Disease".
The results were unexpected for the researchers
The results of the pharmacokinetic analysis of the relationship between treatment dose, blood level and pharmacological activity of the drug hydromethylthionine in the brain of humans were unexpected even for the researchers.
Even the lowest dosage achieved measurable success
The study concludes that even the lowest dose of hydromethylthionine, previously tested in two global phase 3 clinical trials (8 mg / day), produces concentration-dependent effects on cognitive decline and brain atrophy.
The drug blocks the abnormal aggregation of tau protein
Hydromethylthionine is taken in tablet form and is based on a compound that is also called LMTM. The drug blocks the abnormal aggregation of tau protein in the brain, which is considered a major driver of clinical dementia.
The effect of different doses has been studied
In phase 3 global clinical studies, which were carried out between 2012 and 2016 on almost 1,700 people with mild to moderate Alzheimer's disease, the effects of hydromethylthionine in doses of 150-250 mg / day were compared with a low dose of only 8 mg /Day. Surprisingly, there was no difference in clinical outcomes between the high doses and the low dose hydromethylthionine.
Pharmacokinetic population analysis performed
In addition, a population pharmacokinetic analysis using the drug's blood plasma concentration data was performed on 1,162 subjects to determine the relationship between blood values and drug effects on the brain. With 8 mg / day and blood levels in the range of 0.3-0.8 ng / ml, the maximum effect was already evident and plasma concentrations in the range of 4-21 ng / ml generated by higher doses brought no additional, reports the Research team.
A slightly higher dose would be suitable for all people
A slightly increased dose of 16 mg / day of hydromethylthionine could ensure that all affected people have the right blood levels of the drug, but even higher doses are of no use to the current study results. The pharmacokinetic profile explains why the pharmacological effects of hydromethylthionine were not better at higher doses.
Maximum effects can be reduced by other drugs
The analysis also showed that hydromethylthionine has a similar concentration-activity profile in patients who take the drug as an add-on to the routinely used drugs in Alzheimer's. However, the maximum effect was reduced by half in these patients, presumably due to drug interactions with hydromethylthionine, the research team explains.
Simply taking the medication is a huge advantage
An advantage of hydromethylthione is the simple form of admission, for which patients do not need to go to separate clinics to receive intravenous infusions or injections. This is a key difference from various other treatments for Alzheimer's that are currently being tested in clinical trials.
The effect achieved was three times as strong as with current treatments
In addition to reducing brain atrophy, strong cognitive effects of the treatment were seen in the patient group with the higher blood values of hydromethylthionine at a daily dose of 8 mg. The effect achieved on the so-called ADAS scale was around 7.5 points. This means that it was three times as high as the current routine treatments for Alzheimer's. This would correspond to a 85 percent reduction in cognitive decline over a period of 65 weeks, the researchers explain. (as)
Author and source information
This text corresponds to the specifications of the medical literature, medical guidelines and current studies and has been checked by medical doctors.
- Bjoern O. Schelter, Helena Shiells, Thomas C. Baddeley, Christopher M. Rubino, Harishd Ganesan et al .: Concentration-Dependent Activity of Hydromethylthionine on Cognitive Decline and Brain Atrophy in Mild to Moderate Alzheimer's Disease, in Journal of Alzheimer's Disease : November 28, 2019), Journal of Alzheimer's Disease