Novartis announced a collaboration with Banner Alzheimer's Institute (BAI) on a pioneering clinical study in Alzheimer's disease (AD) prevention. The study will determine whether two Novartis investigational anti-amyloid treatments can prevent or delay the emergence of symptoms of AD in people identified as being at genetic risk for developing the late-onset form of the disease.
Using an innovative trial design, the two treatments will be given in cognitively healthy people at genetic risk of developing the build-up of amyloid protein in the brain that may eventually lead to AD. One treatment is an active immunotherapy, a treatment that stimulates an immune response, and triggers the production of natural antibodies against amyloid. This investigational treatment, given via an injection, is in phase II clinical development. The second treatment, 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.
Early in the course of Alzheimer's disease, amyloid build-up in the brain is evident and is thought to be a key factor in driving the subsequent progressive damage and clinical symptoms in AD. The aim of the study is to assess whether these investigational treatments could prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer's disease. Current treatments for AD only address the symptoms of the disease. It is estimated that around 44 million people globally have Alzheimer's or a related dementia.
"We are delighted to announce this collaboration with the Banner Alzheimer's Institute." said David Epstein, Division Head, Novartis Pharmaceuticals. "This trial reinforces Novartis' focus to following the science of the disease and outlines our continued commitment to the study of Alzheimer's Disease.There is a huge unmet need for treatments that prevent or delay the development of the disease and we are excited about taking research in Alzheimer's to the next level."
The study, which will be run in collaboration with the BAI, will involve more than 1,300 cognitively healthy adults, ages 60 to 75, with a genetic risk of developing symptoms of AD because they inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele - one from each parent. About 2 per cent of the world's population has this genetic profile, which is strongly linked to late-onset AD. Participants in the study will be given either the active immunotherapy, the BACE inhibitor or placebo. Pending regulatory approval, the study is planned to start in 2015 in sites in North America and Europe.
Novartis has a strong commitment to the treatment of Alzheimer's Dementia. Exelon Patch (rivastigmine transdermal system) is approved for the treatment of mild-to-moderate Alzheimer's disease dementia (AD) in more than 90 countries. Exelon Patch is also approved for the treatment of patients with severe AD in the US and nine additional countries. In Europe, the high-dose patch (15 cm2) for mild-to-moderately severe AD was launched in several markets in 2013. Exelon Patch has been used to treat more than 3 million patients in clinical trials and the post-marketing setting.
Banner Alzheimer's Institute (BAI) is a nonprofit organization dedicated to the goal of ending Alzheimer's disease without losing another generation. It is helping to launch a new era of Alzheimer's research-detection, treatment and prevention at the pre-symptomatic stage-and to establish a comprehensive model of care that can be the national standard.