Novartis, Amgen, and the Banner Alzheimer’s Institute (BAI) have expanded their collaboration in Alzheimer’s disease to initiate a new clinical trial, the Alzheimer’s Prevention Initiative Generation Study 2.

Since 2015, Amgen and Novartis have collaborated to develop and commercialize treatments in the field of migraine and Alzheimer’s disease. This includes investigational Amgen drugs in the migraine field, including Aimovig (erenumab) (biologics license application accepted by the US Food and Drug Administration in July 2017) and AMG 301 (currently in Phase I development). In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the US. For the migraine programs, Amgen retains exclusive commercialization rights in the US (other than for Aimovig) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. The companies are also collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in Alzheimer’s disease.

This new trial follows the launch of the Generation Study 1 and is designed to determine whether Novartis’ and Amgen’s CNP520, a BACE1 inhibitor, can prevent or delay the onset of Alzheimer’s disease symptoms in a high-risk population. BACE1 is an enzyme that plays a 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, according to Novartis.

The Generation Study 2 started enrolling participants in the US in August 2017 and is planned to eventually include more than 180 sites in more than 20 countries. This five-year study will recruit approximately 2,000 cognitively healthy participants, aged 60 to 75, who are at high risk of developing Alzheimer’s disease 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 a major genetic risk factor for late-onset Alzheimer’s disease, according to Novartis. 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 Amgen.

Participants will be recruited via multiple venues, including, in the US, the Alzheimer’s Prevention Registry’s GeneMatch program. GeneMatch is a 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.

Source: Novartis and Amgen