Novartis, Amgen and the Banner Alzheimer's Institute (BAI) have announced an expanded collaboration to initiate a new trial - the Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the 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 ß, a protein which accumulates in the brains of individuals with AD years before clinical symptoms begin.
"Expanding our collaboration with Banner Alzheimer's Institute stands testament to our belief that preventing amyloid buildup is one of the most promising approaches to treating Alzheimer's disease," said Vas Narasimhan, M.D., Global Head Drug Development and chief medical officer for Novartis. "If we determine that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy yet high-risk populations, this would represent a tremendous breakthrough for those that may face this debilitating disease."
The Generation Study 2 started enrolling participants in the US in August 2017, and will eventually include more than 180 sites in more than 20 countries around the world. This five-year study will recruit approximately 2,000 cognitively healthy participants, aged 60 to 75, who are at high risk of developing AD 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. This is different from the Generation Study 1, which only targeted those who carry two copies of the APOE4 gene. APOE4 is the 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 carries two copies. Eligible participants will be randomized to receive placebo or one of two doses of CNP520 (15 mg or 50 mg), co-developed by Novartis and the biotechnology company Amgen.
"This expanded collaboration builds upon the API Generation Study 1 which launched last year, and is another step in our effort to take clinical trials to a critical new stage," said Pierre N. Tariot, MD, co-director of API and director of BAI, a division of Banner Health, one of the largest nonprofit healthcare systems in the US "This approach continues to shift the Alzheimer's research paradigm from reversing disease damage to attacking its root cause before symptoms surface. It is our hope that by targeting people earlier, we will have a better chance of delaying or preventing the onset of the disease."
Participants will be recruited via multiple venues, including, in the US, the Alzheimer's Prevention Registry's GeneMatch program (www.endALZnow.org/GeneMatch). GeneMatch is a first-of-its-kind program designed to identify a large group of people interested in volunteering for Alzheimer's disease prevention research studies, based in part on their APOE genetic information.