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European Consortium to Create Alzheimer’s Trial Panel

Illustration of brain (NIDA)

(National Institute of Drug Abuse)

15 January 2015. A group of 35 universities, companies, and research institutes in Europe are forming a panel of people in the earliest stages of Alzheimer’s disease to test new treatments that prevent the disorder. The five-year European Prevention of Alzheimer’s dementia or EPAD project is part of the Innovative Medicines Initiative, a joint undertaking of the European Union and pharmaceutical industry in Europe.

According to data from Alzheimer’s Disease International cited by EPAD, Alzheimer’s disease afflicted some 44.4 million people worldwide in 2013 and is expected to increase to 135.5 million by 2050. Current treatments aim to slow the progress of Alzheimer’s disease or alleviate symptoms, and bringing drugs to market that prevent or treat the disease directly has been a slow process, despite substantial investments by companies and governments.

The EPAD project plans to focus on people in early stages of Alzheimer’s disease, including individuals who test positive for Alzheimer’s biomarkers but are not yet exhibiting symptoms. New tools and test are available that identify individuals in these early stages.

The aim of the initiative is to create an infrastructure for testing new treatments that prevent further progression of the disorder. A continuing problem in testing treatments for Alzheimer’s disease is the difficulty in recruiting a sizeable number of subjects and establishing study sites needed for clinical trials, particularly for individual companies or universities developing new therapies.

To overcome these obstables, the EPAD project will assemble a panel of people testing positive for biomarkers or in the early stages of Alzheimer’s disease for clinical trials of new drugs to prevent the onset or further progression of the disease. The panel will be drawn from participants in existing national and regional studies in Europe, numbering about 24,000. From that first group, some 6,000 individuals will be selected for long-term follow-up studies. Then a core group of about 1,500 individuals will be selected for proof-of-concept trials at multiple sites.

EPAD’s organizers say this approach will make it possible to more quickly test several treatment options at once. The project organizers add that results from studies with these panels will be made publicly available.

“This project has numerous advantages over current approaches,” says Serge Van der Geyten, the representative from Janssen Pharmaceutica NV, a division of Johnson & Johnson, in an EPAD statement. “These include the excellent pre-trial characterisation of subjects to inform selection and reduce screen failure, the establishment of the highest possible quality study sites across Europe, the rapid decision making on the likely success of a drug — or combination of drugs — in subsequent confirmatory trials, as well as access to a shared placebo group.”

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