Banner Alzheimer’s Institute (BAI) researchers in Phoenix have begun enrolling the first participants in a multi-site study to determine whether two investigational anti-amyloid compounds—an active immunotherapy and an oral medication—can prevent or delay the emergence of symptoms of Alzheimer’s in people identified by genetic markers as being at particularly high risk for developing the disease at older ages.
The five-year Alzheimer’s Prevention Initiative (API) Generation Study will involve more than 1,300 cognitively healthy older adults, ages 60 to 75, who are at high risk of developing Alzheimer’s symptoms because they inherited two copies of the e4 type of the apolipoprotein (APOE) gene—one from each parent. Roughly one in four people carry a single copy of the e4 type of the APOE gene, which is strongly linked to late-onset Alzheimer’s, and about two percent of the world’s population carries two copies.
“Enrolling the first study participants marks a major milestone for the trial and Alzheimer’s prevention research,” said Pierre N. Tariot, MD, one of the API leaders and director of BAI, a division of Banner Health, one of the largest nonprofit healthcare systems in the United States. “By studying this high-risk population, we hope to assess each treatment’s potential to preserve memory and thinking as well as their effects on biological measures of the disease.”
The study is sponsored by Novartis, a Swiss pharmaceutical company, and Amgen, a biotechnology company based in Thousand Oaks, CA, in collaboration with BAI, with funding from the National Institute on Aging, part of the National Institutes of Health (NIH), as well as the Alzheimer’s Association, FBRI, GHR Foundation and Banner Alzheimer’s Foundation.
The Generation Study is part of the API, an international collaborative led by BAI to accelerate the evaluation of promising treatments. It will enroll at about 90 sites across North America, Europe and Australia, including BAI’sPhoenix headquarters.
The API Generation Study is the first to incorporate genetic testing and counseling into the screening process. Participants will be required to learn whether they carry none, one or two copies of the e4 type of the APOE gene. Only those who learn they have two copies will be invited to participate. The API Generation Study will provide genetic counseling in person, by phone or through video-conferencing.
Participants will be recruited via multiple venues, including the Alzheimer’s Prevention Registry’s GeneMatch program. – PRNewswire