Novartis and Amgen extend collaboration to launch second trial in Alzheimer’s

Amgen and Novartis announced an expanded collaboration with the Banner Alzheimer’s Institute (BAI) in the Alzheimer’s Prevention Initiative Generation Study II, to assess if the beta-secretase (BACE1) inhibitor CNP520 can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population.

BACE1 is an enzyme that plays an important role in the production of amyloid beta, a protein which accumulates in the brains of individuals with Alzheimer’s disease years before clinical symptoms begin.

“We are pleased to support the launch of the Generation Study II with our partners at Novartis and Banner Alzheimer’s Institute to further explore promising potential therapeutic options for this highly debilitating disease,” said Sean Harper, executive vice president of research and development at Amgen. “Through the unique combination of genetic testing and counselling in cognitively healthy adults, the Generation Study II [takes] an innovative clinical approach that may offer insight towards Alzheimer’s prevention for those at highest risk for developing the disease.”

The Generation Study II started in the US in August, and will eventually include more than 180 sites in over 20 countries. The five-year trial will recruit approximately 2,000 cognitively healthy participants, ages 60 to 75, who are at high risk of developing Alzheimer's based on their age, and who carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid.

In this respect, the new study is different from the Generation Study 1, which is only recruiting people who carry two copies of the APOE4 gene, a major genetic risk factor for late-onset Alzheimer’s disease. Roughly one in four people carry a single copy of the APOE4 gene, but only about two percent of the world’s population carry two copies. Participants will be randomised to receive placebo or one of two doses of CNP520 (15 mg or 50 mg), which is being co-developed by Amgen and Novartis. 

“This approach continues to shift the Alzheimer's research paradigm from reversing disease damage to attacking its root cause before symptoms surface,” said Pierre Tariot, director of BAI, a division of Banner Health, one of the largest non profit healthcare systems in the US. “It is our hope that by conducting research targeting the disease at earlier stages, we will have a better chance of delaying or preventing the onset of the disease.”

Participants will be recruited via multiple venues, including the Alzheimer’s Prevention Registry's GeneMatch programme (www.endALZnow.org/GeneMatch) in the US. GeneMatch is a first-of-its-kind programme designed to identify a large group of people interested in volunteering for Alzheimer’s prevention research studies, based in part on their APOE genetic information.

The Alzheimer's Prevention Initiative (API) is an international collaborative research effort formed to launch a new era of Alzheimer's prevention research. Led by BAI, API conducts prevention trials in cognitively healthy people at increased genetic risk for Alzheimer's disease.

It will establish the brain imaging, biological and cognitive measurements needed to rapidly test promising prevention therapies and provide registries to support enrollment in future prevention trials. API is intended to provide the scientific means, accelerated approval pathway with the cooperation of the regulatory agencies and enrollment resources needed to evaluate promising Alzheimer’s prevention therapies.

Amgen and Novartis have been collaborating since 2015 in the development and commercialisation of treatments for migraine and Alzheimer’s disease.