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IMI launches dementia trials alliance

EU group wants to revamp approach to Alzheimer’s research
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The EU's Innovative Medicines Initiative (IMI) has set up a project to speed up the development of drugs that promise to help prevent Alzheimer's disease.

The €53m effort will concentrate on a new approach to clinical trials for Alzheimer's disease and was announced as G8 leaders met to discuss dementia, a healthcare timebomb that will afflict one in three people in their lifetime. 

In 2010, the World Health Organization (WHO) estimated that the total global societal costs of dementia were a massive $604bn, a figure that can only shoot up as the average age of the global population rises.

By 2050 it is expected that 100 million people worldwide will have Alzheimer's and - with a string of failures for drug candidates aimed at treating patients with early-stage disease - the quest is on to try to identify patients who can be enrolled into trials before symptoms develop.

The IMI wants to completely revamp the Alzheimer's development approach by employing adaptive trials that will not only allow several drugs from multiple pharmaceutical companies to be compared to placebo at the same time, but also make it possible to refine the treatment protocol based on early findings.

For example, drugs can be added to or dropped from the study depending on their early performance, combinations of promising agents can be assessed, and - if a candidate drug appears to be particularly effective in only certain categories of patient - then assignment of that medicine can be preferentially directed to those people.

The IMI points out that adaptive trial designs have already been found to be effective for testing new treatments for breast cancer, but this will be the first time such an approach has been employed in Alzheimer's.

The approach is remarkable as it suggests a high level of cooperation between companies, and provides a concrete example of the type of transparent, open innovation approach that has often been discussed in the industry but rarely implemented.

The IMI has been instrumental in encouraging greater collaboration, and formed a similar partnership approach to antibiotics research earlier this year.

Michel Goldman, the IMI's executive director, said ahead of the G8 summit that the challenge developing new therapies for Alzheimer's is "too great for any single organisation, country or company to tackle alone."

The programme is being funded with €28m from the European Commission and €25m from pharmaceutical companies involved in the project.

Article by
Phil Taylor

11th December 2013

From: PME



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