# Core C:  Clinical Core

> **NIH NIH U19** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2022 · $788,668

## Abstract

Clinical Core Abstract
Virtually all adults with Down Syndrome (DS) have neuropathological changes consistent with Alzheimer Disease
(AD) by age 40, including deposition of β amyloid peptide (Aβ) in diffuse and neuritic plaques, and most will
develop clinical dementia by their late 60s.The high risk for AD has been attributed, at least in part, to triplication
and overexpression of the gene for amyloid precursor protein (APP) on chromosome 21, leading to elevated
levels of Aβ peptides The ABC-DS study is designed to understand the pathophysiological and clinical changes
in adults with DS as they experience progression of AD from its earliest preclinical stages through frank dementia.
The purpose of the Clinical Core is to provide participants with DS (and sibling controls), clinical data, and
biological specimens to enable the goals of each project. This ultimately involves providing a best practice profile
of abilities and health status to arrive at a valid clinical classification of dementia status. The Core will undertake
the longitudinal assessment of a cohort of 720 individuals to maintain an active cohort of 550 adults with DS and
50 sibling controls. Over the course of this five-year project, participants will be seen for up to four evaluations
(separated by 16 months). Data collection will include neuropsychological evaluations, caregiver questionnaires
of functioning and possible dementia symptoms, a physical/neurological examination, blood for genetics,
lipidomics and proteomics analyses, MRI and PET scans (amyloid, tau, FDG) and LP. The accumulating clinical
data will be entered comprehensively into the ATRI database so it can be available for correlative analyses with
the rich biological data generated from the same participants in Projects 1-3. The prospective clinical data will
form the basis of cross sectional and longitudinal analyses of potential biomarkers and will enable the phenotypic
correlations essential to understanding how they relate to disease risk, onset, severity, progression, and
symptoms.

## Key facts

- **NIH application ID:** 10683429
- **Project number:** 3U19AG068054-03S1
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** BENJAMIN L HANDEN
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $788,668
- **Award type:** 3
- **Project period:** 2020-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10683429

## Citation

> US National Institutes of Health, RePORTER application 10683429, Core C:  Clinical Core (3U19AG068054-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10683429. Licensed CC0.

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