Amgen and Novartis said today they will expand their two-year-old collaboration with the Banner Alzheimer’s Institute by launching a new Phase II/III trial designed to assess whether the oral beta-site APP-cleaving enzyme-1 (BACE1) inhibitor CNP520 codeveloped by the companies can prevent or delay symptoms in people at high risk for the memory-robbing ailment.
The value of the expanded collaboration was not disclosed.
The new trial—the Alzheimer’s Prevention Initiative (API) Generation Study 2 (NCT03131453)—will be a five-year study set to recruit approximately 2000 cognitively healthy participants, ages 60 to 75, deemed to be at high risk of developing Alzheimer’s due to their age and their carrying either two copies of the apolipoprotein E (APOE) 4 gene—a major genetic risk factor for late-onset Alzheimer’s disease—or one copy of the gene with evidence of elevated brain amyloid.
Primary endpoints include diagnosis of mild cognitive impairment due to Alzheimer’s or dementia due to Alzheimer’s, whichever occurs first during the study, and change in the Alzheimer’s Prevention Initiative Composite Cognitive (APCC) test score.
Generation Study 2 started enrolling U.S. patients in August and will eventually include more than 180 sites in more than 20 countries. Patients will be randomized to receive placebo or one of two doses of CNP520 (15 mg or 50 mg).  CNP520 is the lead compound of the Amgen–Novartis neuroscience collaboration launched in September 2015, and also of undisclosed value.Testing will also determine the participant’s amyloid status, which will be disclosed by qualified medical personnel. Genetic counselling will be provided in person or by phone. “Through the unique combination of genetic testing and counseling in cognitively healthy adults, the Generation Study 2 exhibits an innovative clinical approach that may offer insight toward Alzheimer’s prevention for those at highest risk for developing the disease,” Sean E. Harper, M.D., EVP of R&D at Amgen, said in a statement.