201901 INCLUDE Project Clinical Trial

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 third domain and will support clinical projects that address critical needs for clinical trial readiness in DS. Projects may facilitate DS research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for DS and its co-occurring conditions, or may increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with DS to enable the design of future clinical trials

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; understanding the complexity of comorbid symptoms in IDD conditions, including DS; support natural history studies in IDD; and develop appropriate and valid biomarkers and preclinical and clinical outcome measures for those with IDD.

Program Contact

Melissa Parisi 
Intellectual Developmental Disabilities Branch (IDDB)

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