# Executive dysfunction as a treatment target for DS clinical trials: An evaluation of its real-world and neural correlates.

> **NIH NIH R21** · DREXEL UNIVERSITY · 2021 · $419,385

## Abstract

Project Summary/Abstract (Project Summary):
As highlighted in the NIH Research Plan on Down Syndrome (DS) and the INCLUDE Project Research Plan,
there is a need to assemble large cohorts of individuals with DS for studies that examine risk and resilience
factors relevant to health and well-being. These studies have implications not only for those with DS but for
individuals in the general population. The proposed research aims to examine factors which impact well-being
in adults with DS by focusing on adult outcomes that are important to individuals with DS and their families,
namely vocational status and adaptive behavior skills. In spite of their importance, these distal outcomes are
unlikely to be good candidate treatment targets for clinical trials research that aims to support developmental
outcomes in individuals with DS. Instead, cognitive skills are likely good proximal treatment targets, particularly
executive function or cognitive control processes that are important for self-regulation and the completion of
complex tasks. Therefore, the proposed research seeks to evaluate executive dysfunction as a treatment target
for DS in young adults. To establish the importance of executive dysfunction, this study, if funded, will: a) examine
links between executive dysfunction and two critically important functional outcomes, vocational status and
adaptive skills in a large cohort of young adults with DS (n=200) from across the United States (with data
gathered online to maximize participant numbers and geographic regions represented); b) evaluate the
moderating influence of autistic traits (co-occurring symptoms likely to have impacts in DS) on executive
dysfunction and these functional outcomes (which is relevant not only to the DS population but also the general
population impacted by autism spectrum disorder); and c) link executive dysfunction with prefrontal cortical
activity using the patient-friendly brain imaging methodology of functional near infrared spectroscopy (fNIRS)
among young adults with DS (n=25). Thus, the proposed research represents an important first step in identifying
the importance of executive dysfunction as a clinical trials treatment target through establishing its links with both
critical distal functional outcomes and proximal neural underpinnings, while also evaluating the potentially
informative moderating influence of co-occurring autistic traits.

## Key facts

- **NIH application ID:** 10295990
- **Project number:** 1R21HD106164-01
- **Recipient organization:** DREXEL UNIVERSITY
- **Principal Investigator:** Nancy Raitano Lee
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $419,385
- **Award type:** 1
- **Project period:** 2021-09-21 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10295990

## Citation

> US National Institutes of Health, RePORTER application 10295990, Executive dysfunction as a treatment target for DS clinical trials: An evaluation of its real-world and neural correlates. (1R21HD106164-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10295990. Licensed CC0.

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