A new Alzheimer’s test drug gets scrapped and then suddenly re-instated with astonishing results. Here’s why it got the much-needed green light (again).
By Terry Owen
A drug for treating Alzheimer’s after onset was shown to have amazingly positive effects, but then was suddenly withdrawn from trial groups, causing immense anger and frustration from trial participants.
This was reported in TIME magazine recently, whose article went on to explain the reasons why the trials were discontinued.
The drug was developed by Biogen, a US pharmaceutical company. According to Biogen, no other treatment for the disease had ever shown such remarkable results.
The first batch trials were progressing smoothly but were suddenly discontinued without any reason, except for citing that some results were promising, others not.
Here’s what happened: one of the trials was started earlier and a lower dosage of the dug given. The second trial used a higher dosage which had much fewer side-effects than expected and produced better results. Only the results of the first trial were examined, and these showed the disappointing results that led to it being discontinued.
Once both the early and later trial results were examined, however, it was clearly seen that higher-dosage results were spectacular, and the trial was resumed. A researcher was quoted as saying that these results gave the team the much–needed confidence to continue with the research.
The company is setting out to invite the original participants back to the trial, where only the drug – and no placebo – will be used. The news couldn’t come at a better time for Alzheimer’s research, which has seen failure upon failure with trials conducted over the last decade.
According to Global prevalence of dementia: a Delphi consensus study, evidence from global surveys is scarce in many regions. It is estimated that 24,3-million people have dementia worldwide with 4,6-million new cases of dementia every year (one new case every 7 seconds). It is expected that the number of people affected will double every 20 years to 81,1 million by 2040.
Most people with dementia live in developing countries (60% in 2001, rising to 71% by 2040). Rates of increase are not uniform; numbers in developed countries are forecast to increase by 100% between 2001 and 2040, but by more than 300% in India, China, and their south Asian and western Pacific neighbours.
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