First vCJD clinical trial to begin


By Emma Young The first clinical trial of a drug to treat vCJD will begin in the UK within weeks, says the Department of Health. However, experts are concerned that the prospects for a fully controlled investigation into the drug’s effectiveness are slim. The trial has been spurred by the announcement in August of the “remarkable recovery” of a 20-year-old British woman, suspected of suffering from vCJD. She received quinacrine, conventionally used to treat malaria, along with chloropromazine, an anti-psychotic drug. However, the scientists at the University of California, San Francisco found the approach produced no improvement in a second American patient with classical CJD, which is not caused by eating BSE-infected material. “We cannot make any predictions at this point,” researcher Carsten North told New Scientist at the time. “But in the absence of any other available therapy, and given that the disease is invariably fatal, this offers the best hope to diseased patients.” An estimated 101 people in the UK have died from vCJD. Five more sufferers are still alive. The UK’s Medical Research Council has now been charged with drawing up plans for a full scale clinical trial of quinacrine. Animal studies showed this drug was the most effective of the two at combating mutated prions. The plans will be finalised “within a few weeks”, says a spokeswoman for the MRC, and the trials will begin almost immediately afterwards. Initial results could be available six months later. Although the trials will involve people with sporadic and familial CJD, as well as vCJD, there are few live sufferers in the UK. This will make it difficult to draw any valid conclusions from the trials. But a more significant problem will be if patients refuse to take inactive placebos. This would mean the effect of quinacrine could not be objectively assessed. “If patients really don’t want to be given the placebo, they would have to be given the treatment,” one UK vCJD expert told New Scientist. “This is going to be very problematic.” Liam Donaldson, the UK government’s chief medical officer, says: “The decision to evaluate quinacrine does not mean that we regard it as a “front runner” in finding an effective treatment for CJD. It simply means that any credible research claim which might offer hope in an otherwise fatal disease must be evaluated.” However, at present, there are no other potential treatments ready to go into human trials. Animal trials involving other drugs, as well as quinacrine and chloropromazine,
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