# Memory Measures for Clinical Trials in Down syndrome and Fragile X syndrome

> **NIH NIH R01** · UNIVERSITY OF ARIZONA · 2020 · $53,951

## Abstract

Project Summary/Abstract
Many new pharmacological treatments for Down syndrome (DS), the most frequent genetic cause of
intellectual disability (ID), are on their way to clinical trial. It is therefore important that there be appropriate and
well-validated cognitive measures to assess their efficacy. We should expect these measures to be supported
by current neuroscientific understanding of the cognitive tasks they are designed to assess. This is the aim of
the current proposal: to support the validity of memory measures for use with children with ID. Many new and
developing pharmaceuticals are designed to work on the hippocampus and associated medial temporal lobe
memory systems, but little work has been done developing tests for ID populations that specifically and
comprehensively asses the memory systems known to correspond with these structures. For this reason, the
parent study has developed and is validating a comprehensive screen-based memory assessment and other
standard memory outcomes (the NIH toolbox) for children with ID. The current proposal sets a goal of
assessing a subset of the parent grant participants (n=30 DS, n=30 typically developing children (TD), ages
11-17 years), with magnetic resonance imaging (MRI). MRI visits will take place at the University of Arizona
where we will collect structural data and functional resting state scans for these participants, with a focus on
hippocampal integrity. The imaging data will make use of protocols developed by co-Is and mentors Chou and
Chen that are designed specifically for difficult-to-scan populations. The training candidate will also benefit
from the developmental cognitive neuroscience and DS expertise from parent award investigators Edgin (PI)
and Lee (co-I). Imaging data will be analyzed for correlation with memory measures in support of the aims of
the parent study, specifically to provide scientific support for 1) alternate form equivalence, 2) evaluation of
measurement reliability and validity, 3) evaluation of a syndrome-specific memory profile of DS, in the context
of 4) measurement of problem behavior. We will also analyze these imaging data alongside sleep data
gathered for the same participants through a competitive supplement, as sleep disruption may influence both
medial temporal lobe functioning and cognitive abilities. This project will provide brain-based evidence
regarding the correlates of these neuropsychological measures, a critical research gap required to
demonstrate their validity. These data will allow us to deepen our support for determining which measures
may provide strong primary outcomes for clinical trials in DS. The results of the proposed project will be novel
in terms of both neuroimaging data collection and in terms of the richness of memory data collected for the
same participants, which will allow us to more specifically understand the DS memory profile and provide well-
researched support for the memory measures assessed under the parent grant.

## Key facts

- **NIH application ID:** 10166053
- **Project number:** 3R01HD088409-05S1
- **Recipient organization:** UNIVERSITY OF ARIZONA
- **Principal Investigator:** Jamie Edgin
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $53,951
- **Award type:** 3
- **Project period:** 2016-09-22 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10166053

## Citation

> US National Institutes of Health, RePORTER application 10166053, Memory Measures for Clinical Trials in Down syndrome and Fragile X syndrome (3R01HD088409-05S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10166053. Licensed CC0.

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