# Pre-Clinical Testing Core

> **NIH NIH U54** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $2,096,019

## Abstract

PROJECT SUMMARY PRECLINICAL TESTING (PTC) CORE
The Preclinical Testing Core (PTC) of the IU/JAX/PITT MODEL-AD Center was established to serve as an expert
technical resource and provide the infrastructure to enable rigorous and unbiased preclinical screening of
proposed therapeutic interventions nominated by the greater research community, and to be tested in mouse
models of late onset Alzheimer’s disease (LOAD) characterized by the MODEL-AD Disease Modeling Project.
The PTC pipeline includes an initial primary screen, which evaluates drug stability, formulation, and confirmation
of the active pharmaceutical ingredient followed by pharmacodynamics (PD) and predictive PK/PD modeling to
inform the dose regimen for long-term chronic efficacy studies. The secondary screen includes chronic treatment
that evaluates in vivo target engagement and disease modifying activity utilizing translational non-invasive
PET/CT and behavioral assessments to determine a therapeutic window. Provided the compound meets the
pre-determined Go/No-GO criteria for these endpoints, evaluation for efficacy on cognitive endpoints correlated
to neurophysiological outcomes as measured by EEG, and fluid and imaging biomarkers are conducted. Finally,
at the conclusion of chronic drug treatment, multi-omics analysis (i.e. proteomics, transcriptomics, and
metabolomics) of brain, blood, and CSF are conducted to determine the molecular signatures in response to
drug treatment. In the initial funding period, the PTC established best practices and validated the pipeline for
both small molecules and biologics as well as established a mechanism for the research community to nominate
their compounds for screening through submission to the STOP-AD portal website. Building on these
milestones, for this next phase of MODEL-AD, the following complementary specific aims are proposed with the
ultimate goals to provide better predictive insight on drug response and improve preclinical to clinical translation:
Specific Aims
Aim 1: Support Drug Screening of STOP-AD Submissions Utilizing the Rigorous PTC Testing Strategy.
Aim 2: Enhance the PTC Screening Strategy to Establish Molecular Response Signatures to Therapeutic
Interventions.
Aim 3: To Establish the Utility of Novel Biomarkers to Predict Efficacy of Therapeutic Interventions.

## Key facts

- **NIH application ID:** 10590448
- **Project number:** 2U54AG054345-07
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Paul Richard Territo
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,096,019
- **Award type:** 2
- **Project period:** 2016-09-30 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10590448

## Citation

> US National Institutes of Health, RePORTER application 10590448, Pre-Clinical Testing Core (2U54AG054345-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10590448. Licensed CC0.

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