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EMA set to also revise guidelines of Alzheimer’s trials

Published on 28/02/18 at 04:45pm

The EMA, following on from the FDA’s lead earlier this month, has announced that it will revise its guidelines on clinical trial studies for the treatment of Alzheimer’s disease from 1 September 2018 onwards.

The move is remarkably similar to the FDA’s move, in that it will allow for clinical trials to be focused at an earlier point disease-progression point – in some cases, before clinical symptoms have become discernible.

In the press release on the updated guidance, the EMA stated: “Recent progress in understanding the pathophysiology of Alzheimer’s disease suggests that the biological changes associated with the disease start to occur as early as 10 to 20 years before clinical symptoms start to appear. Many of the experimental medicines are therefore investigated in earlier disease stages as certain treatments may be more effective at that stage than later in the illness.

“Currently available medicines for Alzheimer's disease only treat its symptoms. However, a number of therapies under development are targeting the biological mechanism of the condition to try and modify the course of the disease.”

Though there are currently still a number of therapies in the pipeline for the treatment of the disease, all of the ones that have posted results have failed, often crushingly.

MSD and Lundbeck both recently posted big failures when a lot of hopes were pinned on their treatments, alongside numerous other defeats that have filtered through early into the new year.

The most notable, and perhaps most worrying, was Pfizer’s decision to pull out of the neuroscience space entirely.

Both the FDA and the EMA’s semi-coordinated action seems designed to ensure that research in the area does not entirely lose support, particularly of big pharma.

The new guidelines will include:

  • Impact of new diagnostic criteria for Alzheimer’s disease, including early and even asymptomatic disease stages, on clinical trial design
  • Factors to be considered when selecting parameters to measure trial outcomes at the different disease stages in Alzheimer’s
  • Potential use of biomarkers in the various stages of medicine development
  • Design and analysis of efficacy and safety studies

The EMA highlighted that these guidelines had been brought about through discussions with the developers of potential medicines, in order to clarify why treatments have struggled to make it out of clinical trials and onto the market.

Ben Hargreaves

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