201901 INCLUDE Project Clinical Trial

Program seeks Council approval for an initiative titled “INCLUDE Project Clinical Trials for Co-Occurring Conditions in Down Syndrome.” 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 development of clinical trials to treat critical and co-occurring health conditions in individuals with DS. The emphasis will be on the acquisition of knowledge that can be translated into new, enhanced, or tailored therapies for treating DS. Research is needed to develop or test new and innovative adaptations of current drugs, interventions, and therapies for the treatment and management of co-occurring conditions in DS. Projects will be encouraged that focus on delivering better healthcare outcomes and should seek solutions that are effective, deliverable, and sustainable in clinical settings beyond the research environment. Projects may address a particular co-occurring condition at a particular stage of development or across the lifespan in people with DS. Outcomes research and health services research related to DS will also be encouraged. Because some aspects of this research area may be new for the trans-NIH scientific community, there will likely be a need to obtain preliminary data or conduct early-stage clinical trial preparatory activities before moving to a full-scale project in this domain.

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; and promote translational and implementation research that will support optimal outcomes for those with IDD.

Program Contact

Melissa Parisi
Intellectual Developmental Disabilities Branch (IDDB)

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