Novartis, Amgen and the Banner Alzheimer's Institute (BAI) have expanded their collaboration to initiate a new study investigating 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 AD years before clinical symptoms begin.
The Generation Study 2 is a five-year trial that will eventually include more than 180 sites in more than 20 countries and around 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 differs from the Generation Study 1, which only targeted those who carry two copies of the APOE4 gene, a major genetic risk factor for late-onset Alzheimer's disease.
"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, 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."