The National Institutes of Health INvestigation of Co‐occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project: Accelerating research discoveries for people with Down syndrome across the lifespan

Abstract

The National Institutes of Health (NIH) has a long‐standing history of support for research in Down syndrome (DS). In response to a 2018 congressional directive for a trans‐NIH initiative to address medical issues in DS, NIH launched the INCLUDE Project (INvestigation of Co‐occurring conditions across the Lifespan to Understand Down syndromE). Reflecting the three INCLUDE components of basic science research, cohort development, and clinical trials, the Project has published funding opportunities to address conditions such as immune disorders and Alzheimer's disease. Due to a steady expansion in dedicated funding over its first 5 years, INCLUDE has invested $258 M in over 250 new research projects. INCLUDE also supports training initiatives to expand the number and diversity of investigators studying DS. NIH has funded an INCLUDE Data Coordinating Center that is collecting de‐identified clinical information and multi‐omics data from research participants for broad data sharing and secondary analyses. Through the DS‐Connect® registry, INCLUDE investigators can access recruitment support. The INCLUDE Research Plan articulates research goals for the program, with an emphasis on diversity of research participants and investigators. Finally, a new Cohort Development Program is poised to increase the impact of the INCLUDE Project by recruiting a large DS cohort across the lifespan.

Establishment of a Biorepository for Down Syndrome: Experience of the Inter-Institutional Multidisciplinary BioBank - BioBIM

“…In this context, a dedicated biobank with serum, plasma, nucleic acids, and PBMCs linked to continually updated clinical data is the best strategy for conducting translational research studies to identify novel therapeutic approaches for individuals with DS [ 17 ]. A biobank is essential for the rapid application of “omics” scientific tools to translational and clinical trials to identify new biomarkers for therapeutic targets and response predictivity [ 46 ], guide the decision making process, and optimize the therapeutic strategy; as suggested by the “precision medicine” of DS [ 15 , 17 ].…”