Novartis, Amgen and the Banner Alzheimer’s Institute (BAI) on Thursday revealed expanding collaboration to initiate a new trial on the Alzheimer’s.
The new trial is Prevention Initiative (API) Generation Study 2, and it follows the launch of the Generation Study 1. Novartis said in its press release that it 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.
Vas Narasimhan, M.D., Global Head Drug Development and Chief Medical Officer for Novartis said that determining BACE1 inhibitors ability to prevent or delay the onset of symptoms in healthy yet high-risk populations, would be a major breakthrough for those that may face this debilitating disease.
The Generation Study 2 started enrolling US patients in August 2017, and will gather people from more than 20 countries, who carry either two copies of the apolipoprotein E (APOE) 4 gene or one copy of the gene with evidence of elevated brain amyloid. The Generation Study 1 only targeted those with two copies of the APOE4 gene. APOE4 is the major genetic risk factor for late-onset Alzheimer’s disease. Patients will be given placebo or one of two doses of CNP520 (15 mg or 50 mg), co-developed by Novartis and the biotechnology company Amgen.
Pierre N. Tariot, co-director of API and director of BAI, a division of Banner Health, one of the largest nonprofit healthcare systems in the U.S. said that this approach is attacking Alzheimer’s disease’s 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,” said Tariot.
Image: A sign marks a building on Novartis’ campus in Cambridge, Massachusetts, U.S., February 28, 2017. Picture taken February 28, 2017. REUTERS/Brian Snyder