# Fluid Biomarker Core

> **NIH NIH P01** · WASHINGTON UNIVERSITY · 2021 · $341,319

## Abstract

Core C: Fluid Biomarker Project Summary/Abstract
 Biomarker data have been critical for defining Alzheimer disease (AD) as a continuum, with pathology
 developing decades prior to the onset of cognitive symptoms that eventually progress to dementia. This
 concept has impacted disease nomenclature, diagnostic criteria, prognostic potential, and clinical trial
 design. Revisions in diagnostic criteria to incorporate biomarker results have been proposed in order to
 increase the confidence of AD as the underlying etiology of a clinical impairment and to permit a diagnosis of
 AD across the disease continuum, perhaps even in the asymptomatic period. Individuals in this preclinical
 stage (as in the ACS) are receiving intense focus as a targeted population for prevention trials aimed at
 identifying disease-modifying therapies that have the best chance of preserving normal cognitive function.
 Since study inception, the Fluid Biomarker Core (Core C) has developed and implemented standard
operating procedures and efficient workflows for the standardized collection, storage, tracking and sharing of
fasted CSF and plasma samples. The ACS has identified biomarker abnormalities that characterize
preclinical AD, defined when these changes develop during the adult lifespan and how they progress. We
are now poised to expand our analyses to characterize the progression of preclinical AD over its 20+ year
course, investigate whether the biomarker changes observed during this preclinical period are predictive of
transition to symptomatic AD, and assess factors that may accelerate or retard this transition. In the next
funding cycle we will extend our proven track record for excellence by continuing to provide the infrastructure
for the collection, storage, and distribution of samples to Project 2 (for the measurement and evaluation of
established, emerging and novel biomarkers [e.g., inflammation] to predict clinical progression) and to
outside AD investigators studying preclinical AD. Fluid biomarker data generated in Project 2 will also be
used by other ACS Projects in their investigations of biomarker associations with imaging measures of
neuroinflammation (via DBSI) and tangle load (via tau PET) (Project 1), the gut microbiome (Project 3) and
physical activity and cardiovascular risk factors (Project 4). In keeping with our emphasis on biomarker
assay rigor, reproducibility and standardization efforts, Core C will also perform annual assay validation and
lot bridging experiments in support of sample analyses carried out in Project 2. We will also continue our
interactions and collaborations with other domestic and international research groups (industrial, academic
and clinical) to foster quality control (QC) efforts required for sample collection protocol harmonization and
biomarker assay standardization. To this end, we propose the following three Specific Aims: 1) Continue to
maintain and grow a biorepository of fasted CSF and plasma for present and futur...

## Key facts

- **NIH application ID:** 10168841
- **Project number:** 2P01AG026276-16
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Anne Fagan
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $341,319
- **Award type:** 2
- **Project period:** 2005-07-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10168841

## Citation

> US National Institutes of Health, RePORTER application 10168841, Fluid Biomarker Core (2P01AG026276-16). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10168841. Licensed CC0.

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