Researchers from the Banner Alzheimer's Institute (BAI), Novartis, and Amgen announced another step forward in the international effort to prevent Alzheimer's disease. The new study, known as the Alzheimer's Prevention Initiative (API) Generation Study 2, will focus on high-risk older adults to determine whether an investigational drug can prevent or delay the emergence of symptoms by combatting the accumulation of amyloid plaques, the protein fragments that form between nerve cells in the brain as a prime hallmark of Alzheimer's.
"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 United States. "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."
The five-year Generation Study 2 will involve more than 2,000 cognitively healthy volunteers, ages 60 to 75, who are at high risk of developing symptoms of Alzheimer's because of their age and because they carry either one or two copies of the e4 type of the apolipoprotein E (APOE) gene, the major genetic risk factor for late-onset Alzheimer's disease. Eligible participants will be randomized to receive one of two doses of the investigational anti-amyloid compound CNP520 (15 mg or 50 mg), co-developed by Novartis Pharmaceutical Corporation and biotechnology company Amgen, or a placebo. The Generation Study 2 began enrolling participants in August and will be conducted at more than 180 sites in more than 20 countries around the world.
Both studies are part of a research effort known as the API Generation Program. The first trial, Generation Study 1, is examining whether two investigational anti-amyloid compounds – CAD106, an active immunotherapy, and CNP520 – can prevent or delay the emergence of symptoms of Alzheimer's among higher-risk cognitively healthy older adults who have two copies of the e4 type of the APOE gene, one from each parent.
Roughly one in four people carry a single copy of the e4 type of the APOE gene, but only about two percent of the world's population carries two copies. The Generation Study 2 will include volunteers with two copies, as well as those with one copy who already show evidence of elevated brain amyloid. Both these groups are at particularly elevated risk of developing symptoms of Alzheimer's by age 85.
The API Generation Program is the first to incorporate both genetic testing and counseling in addition to amyloid disclosure education into the study screening process. For both studies, prospective participants referred to the trial will be required to learn their APOE test results. Only those who learn they have one or two copies may be eligible to participate in the study. In Generation Study 2, testing will also determine the participant's amyloid status, which will be disclosed by qualified medical personnel. Genetic counseling will be provided in person or by phone.