API Generation Program data now accessible to researchers on the AD Workbench
The API Generation Program data can now be analyzed with user-friendly tools on a cloud-based platform to characterize cognitive and biomarker alterations in an exceptionally large number of cognitively unimpaired older adults with one or two copies of the APOE4 allele, the major genetic risk factor for Alzheimer’s disease (AD) and the initial impact of an investigational active amyloid beta immunotherapy and BACE inhibitor in the prevention of AD.
Researchers from around the world can now use the AD Workbench to request access to data from the Alzheimer’s Prevention Initiative (API) Generation Studies 1 and 2, two of the world’s first Alzheimer’s prevention trials of investigational amyloid-modifying drug therapies in persons with the major genetic risk factor for the disease.
Data comes from the Alzheimer’s Prevention Initiative (API), an international research collaboration led by Banner Alzheimer’s Institute that includes public and private partners. The API leads prevention trials in cognitively unimpaired persons who, based on their biological measurements and/or genetic risk, are at increased risk for developing Alzheimer’s at older or younger ages. The program is committed to sharing trial data and samples with the field to advance the early detection, tracking, study, and prevention of the disease.
In addition to the data being available through the Laboratory on Neuroimaging (LONI), the AD Workbench will give additional researchers access to the data and tools needed to capitalize on this shared resource of data. The AD Workbench is a global, cloud-based platform with cutting-edge tools and resources that allow researchers to study, analyze, and compare data in new ways and uncover previously unseen insights. It is interoperable with other data sharing platforms such as DPUK, EPND, GAAIN, and Vivli, and can serve as a connective thread through research projects and data sources. The AD Workbench is available to users at no cost.
“When the world’s best data is made available, findable, and usable by the brightest minds, we enable the discovery and potential validation of novel insights” said Niranjan Bose, interim executive director of the Alzheimer’s Disease Data Initiative. “We thank our partners at API for their commitment not only to groundbreaking therapeutic research, but also making available the data to researchers around the world. Broader access to these datasets can help accelerate progress on early detection, therapeutic development, and prevention of Alzheimer’s disease”.
The API Generation Program studies were sponsored by Novartis and Amgen, in partnership with Banner Alzheimer's Institute and with support from the U.S. National Institute on Aging (NIA) and Banner. They included 120 trial sites from 24 countries.
API Generation Study 1 (NCT0256551) was designed to evaluate cognitive, clinical and biomarker effects of the investigational beta-secretase (BACE1) inhibitor umibecestat and the investigational amyloid beta immunotherapy (i.e., vaccine) CAD106 in cognitively unimpaired 60-75 year-old APOE4 homozygotes (i.e., those with two copies of this gene), including those with or without elevated brain amyloid.
API Generation Study 2 (NCT03131453) was designed to evaluate umibecestat’s effects in a cognitively unimpaired 60-75 year-old APOE4 carriers (APOE4 homozygotes and heterozygotes); APOE4 heterozygotes (i.e., those with one copy of the gene) were required to have elevated brain amyloid.
While the studies were discontinued early due to mild (but ultimately reversible) cognitive worsening in persons treated with umibecestat, the data and related biological samples will give researchers a chance to further assess some of the earliest biological and cognitive changes associated with the predisposition to the disease, evaluate initial effects of the two investigational anti-amyloid treatments, and help inform the design of future prevention trials.
Together, API Generation Studies 1 and 2 provide screening data from about 1,250 APOE4 homozygotes and 9,500 heterozygotes, including about 700 homozygotes and 2,600 heterozygotes who were assessed for the presence or absence of elevated amyloid plaques using positron emission tomography (PET) or cerebrospinal fluid (CSF). In addition, they provide baseline cognitive and clinical, PET, MRI, CSF and plasma biomarker, and related data in up to 690 amyloid-positive and negative homozygotes and up to 1,000 amyloid-positive heterozygotes, with a median follow-up of 6 months. CSF, blood, DNA, and RNA samples are also available to researchers.
“We are excited to provide a shared resource of available prevention trial data (and soon-to-be-available biological samples) and do so in such a large number of persons with one or two copies of the APOE4 gene,” said Eric Reiman, MD, executive director of Banner Alzheimer’s Institute and an API co-leader. “When it comes to advancing the study and prevention of Alzheimer’s, we are all in this together.”
About the Alzheimer’s Disease Data Initiative
The Alzheimer’s Disease Data Initiative is a coalition of leading academic, advocacy, government, industry, and philanthropy organizations that recognizes the need for dementia researchers to find easier ways to share unpublished data, analytical tools, and scientific findings. These partners are working together to accelerate progress towards new diagnostics, treatments, and cures in Alzheimer’s disease and related dementias.
About the Alzheimer’s Prevention Initiative
The Alzheimer’s Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer’s prevention research and find effective prevention therapies as soon as possible. Led by Banner Alzheimer’s Institute, API includes a growing number of prevention trials of putative AD-modifying treatments in cognitively unimpaired persons at biomarker and/or genetic risk, registries, to support enrollment in prevention trials, and a commitment to share data and biological samples with the field in appropriate ways to have the greatest possible impact. For more information, go to alzheimerspreventioninitiative.com.
About Banner Alzheimer’s Institute
Since its inception in 2006, Banner Alzheimer’s Institute has sought to find effective Alzheimer’s disease prevention therapies without losing another generation, establish a new model of dementia care for patients and family caregivers, and forge new models of collaboration in biomedical research. It has made groundbreaking contributions to the unusually early detection, tracking, diagnosis and study of Alzheimer’s, and aims to find the first effective prevention therapy by 2025. It includes API, numerous observational studies and clinical trials comprehensive clinical, family and community service programs, a leading brain imaging research program, and strategic partnerships with public and private research organizations around the world. Learn more at BannerHealth.com/Alzheimers.