Drug that could reverse Alzheimer’s to be tested on patients

A new drug with the potential to halt or even reverse Alzheimer’s disease is expected to be tested in patients later this year, researchers have revealed.

The drug, which tackles a key factor in the development of the disease, is expected to enter the crucial Phase 3 trial – the last stage before seeking regulatory approval – in the latter half of 2010, according to its inventor, Aberdeen University’s Professor Claude Wischik.

Earlier clinical trials of the drug – called remberTM – showed that it could slow progression of Alzheimer’s disease by 84 per cent over 12 months. Furthermore, the effect was sustained over two years. When the results were reported at a conference in Chicago in 2008, they caused worldwide excitement and optimism that, at last, an effective treatment for dementia could be in the pipeline.

But before the drug could move to Phase 3 trials – which will compare it against placebo in larger numbers of patients – millions of dollars in funding have to be raised and regulatory obstacles overcome.

Prof Wischik is optimistic that that ongoing fundraising will permit the Phase 3 trial to begin this year. “This will be a large-scale, international study using around 50 centres,” he said. “We’re moving on substantially from the Phase 2 trial – we’ve beefed up our management team and have really moved on to another level.

“We’re breaking new ground here – the Phase 2 trial provided the first evidence that a drug of this type could arrest progression of the disease, but we believe it can go further than that and perhaps reverse the disease, at least at its early stages.”

The drug acts on the “tangles” which are found in the brains of people with the disease, and which were first described by Alois Alzheimer in 1907. Around two decades ago, Prof Wischik discovered that these tangles were made up of a build up of tau protein, which destroys the brain cells responsible for memory, before going on to kill neurons elsewhere in the brain.

A university spin-out company, TauRx Therapeutics, based in Singapore, developed a novel treatment from a chemical already used in other conditions, which appears to ‘dissolve’ the tangles and halt cognitive decline – the Holy Grail in dementia treatment.

The Phase 2 trial – intended to reveal side-effects as well as efficacy – revealed that the tested form of the chemical worked well at the low and moderate doses, backing the theory that it could arrest the progression of the disease.

It did not work at the highest dose tested due to a problem with the formulation which affected the release of the drug in its active form and this had an impact both on the efficacy and side-effects and limiting the benefit that can be achieved with the older form of the chemical.

Read the full article here at Caledonian Mercury .....