Program seeks Council approval for initiatives under the auspices of the NIH “INCLUDE Project” (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE). 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, but 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 NIH-wide INCLUDE Project was launched in 2018 to enhance the understanding of health and quality-of-life needs for individuals with DS, addressing conditions that are common in people with and without the condition, such as Alzheimer’s disease, autism, leukemia, and heart disease. The INCLUDE Project address these issues by advancing research on DS in 3 components: (1) Targeted, high-risk, high-reward basic science studies in areas highly relevant to DS; (2) Assembly of a large cohort of individuals with DS across the lifespan to perform deep phenotyping and study co-existing conditions; and (3) Inclusive clinical trials of existing and future treatments and interventions for co-occurring conditions in individuals with DS. Since 2018, NIH has invested more than $183 million in over 200 projects on a wide variety of basic science and clinical topics and supported numerous training awards focused on DS. A data coordinating center (DCC) is collating cohort data across the lifespan for visualization and secondary analyses while striving to increase participant and researcher diversity.
This concept will allow initiatives to be developed over the next cycle to meet the purposes of the INCLUDE Project. In FY19-FY20, several FOAs and RFAs were released that focused on innovative basic science projects, animal model generation, clinical trial readiness, phased clinical trials, mentored training and fellowships, and data acquisition and analysis. Many of these funding opportunities were renewed in FY22. In addition, new programs were developed to adapt mobile Health (mHealth) platforms for the DS population, encourage community-based participatory research, and create short courses to train diverse investigators. In FY23, plans include support for a large cohort study that will collect rich phenotypic data, including clinical and blood-based biomarkers, from diverse communities with DS, as well as a biobanking initiative to ensure biospecimens are collected in a uniform manner for broad distribution. Other initiatives may be developed to meet the needs of the program as it evolves and to ensure representation and diversity.
These initiatives align with NICHD Strategic Plan theme 1 (understanding molecular/cellular basis of development), theme 4 (improving child/adolescent health and adult transitions) and theme 5 (advancing safe and effective therapies for those with IDDs). They address many IDD Branch priorities as well.
INCLUDE is being developed by the Office of the Director of NIH, which is supporting and coordinating the INCLUDE Project initiatives. Due to the large number of participating NIH Institutes and Centers involved (at least 18), concept clearance will only be obtained at a single institute; NICHD is serving as the institute of record for clearance for funding opportunities that arise within the INCLUDE Project.
Intellectual and Developmental Disabilities Branch (IDDB)
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