BASEL, Switzerland—Novartis and the Banner Alzheimer’s Institute (BAI) have announced a partnership for a clinical trial in Alzheimer’s disease prevention, specifically looking at whether two investigational anti-amyloid treatments from Novartis are capable of preventing or delaying the emergence of Alzheimer’s disease symptoms in people who are at genetic risk for developing the late-onset form of the disease. As it stands, existing therapies are only capable of providing symptomatic relief for patients.
“We are delighted to announce this collaboration with the Banner Alzheimer’s Institute,” David Epstein, division head at Novartis Pharmaceuticals, commented in a statement. “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 two treatments consist of an active immunotherapy, a Phase 2 investigational treatment triggers the production of natural antibodies against amyloid, and an oral medication about to begin Phase 1 trials, a beta-secretase 1 inhibitor designed to prevent the production of different forms of amyloid. In the trial, the treatments will be administered to cognitively healthy people who have a genetic risk of developing a buildup of amyloid protein in the brain that could lead to Alzheimer’s disease.
Amyloid accumulation in the brain becomes evident early in the course of Alzheimer’s disease and is considered a key factor in the progression, damage and symptoms of the disease. The study, known as the APOE4 trial, will seek to determine whether Novartis’ investigational compounds could serve to prevent, slow or delay the memory loss and other cognitive effects of Alzheimer’s disease.
The five-year trial will be run collaboratively by Novartis and BAI, and will be conducted with more than 1,300 adults aged 60 to 75 who have inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele. Some 2 percent of the world’s population presents with this genetic profile, which is linked strongly to the development of late-onset Alzheimer’s disease. The trial is expected to begin in North America and Europe next year, pending regulatory approval, and is partially funded by a $33.2-million grant commitment from the National Institutes of Health, awarded in 2013, and more than $15 million in philanthropic and in-kind contributions by Banner Alzheimer’s Foundation.
“We hope Novartis’ substantial investment of resources and expertise will lead to a significant breakthrough in Alzheimer’s research,” Dr. Pierre N. Tariot, study director for BAI, said in a press release. “We are taking clinical trials to a critical new stage. This approach shifts the research paradigm from trying to reverse disease damage to attacking and preventing its cause, years before symptoms could surface.”