In an ageing society the very high incidence of dementia and Altzheimer's disease is a worry to us all. Hardly anyone remains untouched by the gradual memory loss, loss of faculties and the slow disintegration of the personality. Most families have a relative or close friend who is an Altzheimer victim. In the UK alone, according to research, over 1 in 3 people over 65 die with a form of dementia.
Apart from the terrible burden this imposes on carers (often members of the same family), the social and economic costs are becoming insupportable. Fortunately, although there are no cures or guaranteed preventative measures that can be taken, the situation is changing. There is no Altzheimer cure but drugs currently in the research "pipeline" may be able to halt the process - and even put it into reverse. However, this does depend upon early diagnosis and treatment. One such drug is methylthioninium chloride, otherwise known as "methylene blue"
Surprisingly, methylene blue is used in aquaculture and by tropical fish hobbyists as a treatment for fungal infections. It is also used as an industrial dye but has medicinal uses too: it was identified as early as 1891 as a successful treatment for malaria. More recently it has been it has been claimed to slow the decline in people with Altzheimer's.
A modified version of methylene blue was used in a Phase II trial (people, not animals) in which 12-month data appeared to suggest that 60mg taken orally three times a day slowed cognitive decline as measured by as much as 81%. The results of this trial, full details of which have not been released "for reasons of commercial confidentiality" have been greeted by some researchers with a high level of skepticism but this has not stopped the from setting up new trials which have now started.
The company in question, is not one of the major pharmaceutical companies that have massive research funds at their disposal. In fact, the company was founded by the lead researcher, Professor Claude Wischik of the University of Aberdeen, U.K and has raised more than $300,000 from private investors to enable the trials to proceed. In reply to the skepticism, Prof. Wischik has said: "There is nothing to hide. The data have been presented in excruciating detail to regulatory authorities in the U.S. and Europe. They have given the go-ahead for our Phase 3 program based on the Phase 2 data.
When dramatic and exciting claims like this are made, critics are apt to say "put your money where your mouth is" and $300,000 makes it clear that this ongoing research project has the confidence of its backers.
These Phase 3 clinical studies marks an important step forward in our quest to find a disease-modifying agent that can help slow or halt the progression of Alzheimer's disease. Unlike cancer where we often talk about 'survivors'. In Alzheimer's there are no 'survivors'. Alzheimer's is a terminal illness, so a medicine that can keep people functioning at home is essential.
How long must we wait for the results of the Phase III trial? This cannot be predicted but this news gives us new hope.
The new drug will not be available until the trial has been successfully concluded and has received regulatory approval. Please remember that it can be dangerous to experiment by self-medicating without seeking the advice of a medically qualified professional.
