Date: 2014-07-15
Type of information: Clinical research agreement
Compound: investigational anti-amyloid treatments (BACE inhibitor and active immunotherapy)
Company: Novartis (Switzerland) Banner Alzheimer\'s Institute (USA - Denmark)
Therapeutic area: Neurodegenerative diseases
Type agreement: collaboration clinical research
Action mechanism:
Disease: Alzheimer’s disease
Details: * On July 15, 2014, 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. The APOE4 study’s new website, which will launch in 2015, will create a platform to explain the study, register potential participants and provide disclosure information and consent forms. Volunteers who meet the study criteria will be asked to mail a sample of their genetic material (such as a cheek swab) to a laboratory. The volunteers will learn the results of that test in the context of possibly enrolling in the trial.
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 (beta-secretase1) inhibitor, is an oral medication about to enter phase I trials and is designed to prevent the production of different forms of amyloid. 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.
The five-year APOE4 trial will involve more than 1,300 cognitively healthy older adults, ages 60 to 75, at high risk of developing symptoms of Alzheimer’s because they inherited two copies of the apolipoprotein E (APOE4) gene—one from each parent. About 2 percent 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 at approximately 60 sites in Europe and North America, including BAI’s headquarters in Phoenix, Ariz.
Financial terms: The study is partially funded by a $33.2 million grant commitment from the National Institutes of Health (NIH),awarded in 2013, and more than $15 million in philanthropic and in-kind contributions by Banner Alzheimer’s Foundation. It is part of the Alzheimer’s Prevention Initiative (API), an international collaboration led by BAI to accelerate the evaluation of promising prevention therapies.
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