# Clinical Core

> **NIH NIH U19** · NORTHERN CALIFORNIA INSTITUTE/RES/EDU · 2023 · $14,151,087

## Abstract

Clinical Core: Summary/Abstract
The Clinical Core serves two primary functions for the ADNI project: day-to-day coordination of all clinical
activities at the ADNI sites, and oversight of the scientific clinical aims. Project management, regulatory
oversight, site management and monitoring, clinical data collection and management and site contracting are
managed at the USC Alzheimer’s Therapeutic Research Center (ATRI), which also coordinates the NIA
Alzheimer’s Clinical Trials Consortium; ADNI procedures mirror the ATRI clinical trials procedures. Overall
direction to the scientific aims of the Clinical Core, focused on the study of relationships among the cognitive,
clinical, biofluid and imaging markers of AD to inform therapeutic trial design are jointly led by Drs. Ron Petersen
at the Mayo Clinic and Paul Aisen at USC.
To maintain the value of the longstanding ADNI cohorts, the Clinical Core will focus on retention and continued
follow-up of the ADNI3 cognitively normal (CN) participants and those with mild cognitive impairment (MCI) or
dementia. New participants will be recruited from a web-based cohort utilizing plasma assays of AD
neurobiology. The Clinical Core will collaborate closely with the new Engagement Core to assure that 50-60%
of new participants will be from under-represented populations (URPs; e.g., Black, Latinx; low socioeconomic
status). Almost all ADNI3 assessments will be continued in ADNI4 to preserve the rich longitudinal dataset, but
novel web-based unsupervised computerized cognitive assessments and new sociocultural measures will be
added in ADNI4.
The scientific aims of the Clinical Core include continued characterization of the cross-sectional features and
longitudinal trajectories of CN and MCI participants, including those who progress to dementia; assessment of
the cross-sectional and predictive value of remote and in-person cognitive assessments along with plasma
amyloid, phosphorylated tau and neurodegeneration assays; and application of these findings to optimal clinical
trial designs.

## Key facts

- **NIH application ID:** 10704658
- **Project number:** 5U19AG024904-17
- **Recipient organization:** NORTHERN CALIFORNIA INSTITUTE/RES/EDU
- **Principal Investigator:** Paul S. Aisen
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $14,151,087
- **Award type:** 5
- **Project period:** 2004-09-30 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10704658

## Citation

> US National Institutes of Health, RePORTER application 10704658, Clinical Core (5U19AG024904-17). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10704658. Licensed CC0.

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