Novartis And BAI Join Hands In AD Prevention Study

Novartis and Banner Alzheimer's Institute (BAI) announced that they are joining in collaboration to conduct a pioneering prevention clinical study for Alzheimer’s Disease.

The five-year study will investigate the efficacy of two of Novartis’ experimental anti-amyloid treatments in preventing, slowing, or delaying the emergence of AD symptoms. The trial will enroll more than 1,300 people ages 60 to 75 identified as being at genetic risk the late-onset form of Alzheimer’s. This is determined by the patient’s possession of two inherited genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele — one from each parent. APOE4 allele is strongly implicated in the late-onset of AD.

In accordance to the study’s design, the two investigational treatments will be administered in cognitively healthy people with the genetic potential to develop amyloid build-up in the brain and eventually AD. The first treatment is an injected drug in Phase II development while the second is an orally taken BACE inhibitor set to begin Phase I trials. The BACE inhibitor helps prevent the production of various forms of amyloid, which upon building up, cause the memory loss associated with Alzheimer’s disease.

Existing treatments for Alzheimer’s tackle only the symptoms of the disease, which affects around 44 million people around the world. Addressing amyloid build-up in the early stages of the disease could impact the subsequent escalating damage and clinical symptoms seen in AD patients.

David Epstein, Division Head of Novartis Pharmaceuticals, said that the company is pleased to collaborate with Banner Alzheimer's Institute in studying potential preventive treatments for Alzheimer’s disease.

Dr. Pierre N. Tariot, study director for BAI, said, “We hope Novartis’s… resources and expertise will lead to a significant breakthrough in Alzheimer’s research. 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.”

The APOE4 study will launch in 2015 at an estimated 60 sites across the EU and North America.