201901 INCLUDE Project Transformative

Program seeks Council approval for an initiative titled “INCLUDE Project Clinical Trial Readiness Award.”  Although Down syndrome (DS) is the most common genetic cause of intellectual and developmental disabilities (IDD), and in the past 25 years, the average lifespan has doubled, from 30 to 60 years, individuals with DS face significant and changing health challenges and have often been excluded from participation in research that could improve their health outcomes and quality of life.

The FY18 Budget appropriation required “a new trans-NIH Down syndrome initiative… to study trisomy 21 [and] to improve the health and neurodevelopment of individuals with Down syndrome and typical individuals at risk for Alzheimer's disease, cancer, cardiovascular disease, immune system dysregulation, and autism, among others.…” The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) initiative aims to address these issues by advancing research on Down syndrome in 3 domains: (1) targeted, high-risk, high-reward basic science studies of trisomy 21; (2) assembly of a large clinical cohort of individuals with DS across the lifespan; and (3) inclusive clinical trials research of current and future therapies for co-occurring conditions in DS.

This initiative will focus on research in the first domain and will support unusually innovative research projects, which, if successful, would have a major impact in understanding the biology of DS and the development of new treatments for health conditions experienced by individuals with DS. To be considered transformative, projects would have the potential to create or overturn fundamental scientific paradigms through novel approaches, transform the way research is conducted through the development of novel tools or technologies, or lead to major improvements in health through the development of highly innovative therapies, diagnostic tools, or preventive strategies.

This initiative is being developed by the Office of the Director of NIH, which is supporting and coordinating the 4 planned new INCLUDE initiatives in 2019. Due to the large number of participating NIH Institutes and Centers involved (at least 18), the NIH Office of Extramural Research indicated that concept clearance will only be required at a single institute. Therefore, NICHD is serving as the institute for clearance for this initiative and the three additional ones proposed as part of INCLUDE.

This initiative relates to the NICHD Vision and IDD Branch priorities that include: understanding developmental trajectories and key biological markers for 5 behavioral or cognitive disorders and understanding the complexity of comorbid symptoms in IDD conditions, including DS.

Program Contact

Melissa Parisi 
Intellectual Developmental Disabilities Branch (IDDB)

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