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Novartis and Banner in Alzheimer’s Genetic Predisposal Study

16.07.2014 -

Novartis is collaborating with Phoenix, Arizona-based US non-profit Banner Alzheimer's Institute (BAI) on a clinical study to determine whether two of the Swiss pharmaceutical giant's investigational anti-amyloid treatments can prevent or delay the emergence of symptoms in people identified as being at genetic risk for developing the late-onset form of the disease.

The study funded with a $33.2 million grant awarded in 2013 by the US National Institutes of Health and supplemented by $15 million from Banner will involve more than 1,300 cognitively healthy adults, ages 60-75, who have a genetic risk of developing symptoms of AD because they inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele.

About 2% of the world's population is believed to have this genetic profile, which is strongly linked to late-onset Alzheimer's disease.

In the trials planned to start in 2015 in North America and Europe, pending regulatory approval, the two Novartis drugs will be given via injection to cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to the disease. Others will receive a placebo.

One of the treatments is an active immunotherapy that stimulates an immune response and triggers the production of natural antibodies against amyloid. This investigational treatment is in phase II clinical development. The second, a BACE inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid.

More than five million Americans have Alzheimer's disease, the most common form of dementia, and the number is expected to triple by 2050, according to the Alzheimer's Association. Novartis points to an estimated 44 million people globally with the disease or a related dementia. Current treatments only address the symptoms of the disease.

The Basel, Switzerland-based drugmaker believes it could take nine years before the studies show results. The work builds on Banner's Alzheimer's Prevention Initiative in collaboration with Genentec that began with $100 million study on 300 people in Colombia who carry a rarer form of genetic mutation that triggers symptoms at the age of 45.