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The Alzheimer’s Therapeutic Research Institute, Keck School of Medicine of USC (ATRI) will be participating in the Alzheimer’s Biomarker Consortium — Down syndrome (ABC-DS) project. The National Institutes of Health (NIH) recently funded the study, providing an expected $109 million over five years, to help researchers better understand how Alzheimer’s disease develops in people with Down syndrome.

“We are very excited to be part of this large, collaborative project to better understand Alzheimer’s disease in people with Down syndrome” said Michael Rafii, MD, PhD, Director of Medical Safety at the ATRI and principal investigator of the Alzheimer’s Clinical Trial Consortium-Down syndrome (ACTC-DS). “This effort will be critical to developing treatments for AD in people with Down syndrome, a population that is genetically predisposed to developing AD.” ACTC-DS is an NIH-funded consortium that will bring the latest Alzheimer’s therapeutics to the Down syndrome population.

Michael Rafii

“The ABC-DS project is built on a strong foundation of research tracking the trajectory of AD-related biomarkers in people with Down syndrome. While there are some features in the biomarker profiles that are shared with late onset AD, the unique biology accompanying Down syndrome requires focused investigation. With renewed funding from NIH, ABC-DS will provide valuable information and fill gaps in our knowledge of how biomarker changes relate to the development of Alzheimer’s disease and cognitive decline in Down syndrome. The valuable experience that ATRI brings to ABC-DS will ensure that the ACTC-DS effort led by Rafii will effectively use this information to design Alzheimer’s disease prevention trials ideally suited for people with Down syndrome.” said Dr. Brad Christian, Professor of Medical Physics and Psychiatry at the University of Wisconsin–Madison and one of the Principal Investigators of ABC-DS.”  

The Coordinating Center for the project is based at the University of Pittsburgh. ATRI’s Clinical Operations, Medical Safety and Informatics Units will be involved in the development and conduct of this study. ATRI’s Clinical Operations Unit will provide data management expertise of data collection, data transfer, maintenance, reporting, and quality control for this project. The Medical Safety Unit will coordinate and perform on-site and remote clinical site monitoring of hundreds of participants’ visits over the next 5 years across all clinical sites. Key efforts of the ATRI Informatics Unit include the development and maintenance of the ATRI electronic data capture (ATRI EDC) system, a secure, cloud and web based clinical trial management system. The ATRI EDC serves as the anchor of a comprehensive trial information management platform that is a central component of ATRI’s global trial management infrastructure. This platform supports the efficient collection of multiple data types that include clinical, demographic, neuropsychological, concomitant medications, adverse events, intervention compliance, biosamples (fluid, tissue), neuroimaging, genetic, and multimedia data.

Arthur Toga

Arthur W. Toga, PhD, director of the Mark and Mary Stevens Neuroimaging and Informatics Institute (USC Stevens INI) at the Keck School of Medicine of USC, is also part of the ABC-DS project. The USC Stevens INI will contribute its expertise in databasing and Alzheimer’s disease.

Funding support for this research is provided by NIH’s National Institute on Aging, Eunice Kennedy Shriver National Institute of Child Health and Human Development and INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project. The INCLUDE project seeks to investigate conditions that affect individuals with Down syndrome and the general population, such as Alzheimer’s disease, autism, cataracts, celiac disease, congenital heart disease and diabetes.

The ABC-DS project involves collaboration between the  following institutions: University of Pittsburgh School of Medicine, University of Wisconsin-Madison, University of Cambridge, Columbia University Irving Medical Center, New York State Institute for Basic Research in Developmental Disabilities, University of California Irvine, University of Kentucky, Massachusetts General Hospital, Washington University School of Medicine in St. Louis, and University of North Texas Health Science Center.

The ABC-DS research will be funded by NIH grant U19AG068054.

ACTC is funded by a NIH Cooperative Agreement number U24AG057437.

For more information, visit: https://www.nia.nih.gov/health/abc-ds-information-patients-and-families.