# Core B: Clinical Core

> **NIH NIH P30** · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · 2020 · $747,137

## Abstract

PROJECT SUMMARY/ABSTRACT
The Clinical Core (CC) of the Arizona ADCC is a consortium of five recruitment sites providing catchment
areas throughout the state that comprise a standardized unit under a single Clinical Core Director. Since its
inception, the CC has had an over-arching interest in the study of preclinical Alzheimer's disease (AD) and the
accelerated evaluation of AD prevention therapies. It includes a cohort of cognitively unimpaired and annually
assessed APOE e4 homozygotes (HMs), heterozygotes, and non-carriers, and has led us to incorporate
longitudinal UDS assessments in an independently funded genetically enriched Arizona APOE cohort. CC
resources are used to adjudicate their progression to mild cognitive impairment (MCI) and dementia leading to
CC enrollment and consent for enrollment into our Brain and Body Donation Program (BBDP). The CC has
provided subjects, DNA, longitudinal cognitive data and blood samples to characterize the preclinical course
and trajectories of cognitive decline in unimpaired persons at three levels of genetic risk for AD; it has
supported our effort to characterize PET, MRI and cerebrospinal fluid (CSF) changes associated with
preclinical AD using independent NIA, state and organizational funds. It includes Latino and Native American
APOE4 carriers and non-carriers to clarify the relevance of our advances to these understudied populations. It
has led to collaborative research in other groups at genetic risk for AD, including children, young adult APOE4
carriers, Colombian presenilin 1 (PSEN1) E280A mutation carriers from the world's largest autosomal
dominant AD (ADAD) cohort, and Down syndrome patients. It has provided data to help inform the design,
statistical power, and optimized endpoints for our Alzheimer's Prevention Initiative (API) and API's ADAD and
APOE4 HM trials. The CC maintains a target of 500 participants at all stages of the aging-dementia spectrum
including 350 normal controls, 50 patients with MCI, and 100 with AD and other forms of degenerative
dementia. Embedded within these diagnostic categories are defined Latino and Native American cohorts. The
CC capitalizes on our multi-institutional diagnostic consensus conference, centralized data management
program, and close working relationships with each of the other Cores. All subjects undergo standardized
diagnostic testing that: 1) fulfills strict entrance criteria; 2) includes demographic, historical, medical,
neurological, psychiatric, neuropsychological, and genetic measures; 3) incorporates the NACC Uniform Data
Set (UDS); and 4) employs culturally sensitive test procedures. Patients eligible for enrollment and those
completing annual follow-up are discussed in a biweekly diagnostic consensus conference. All undergo APOE
genotyping at entry, and an annual standardized neuropsychological battery of tests at all sites. All are offered
enrollment in the Brain Donation Program for neuropathological confirmation of clinical diagnoses. ...

## Key facts

- **NIH application ID:** 9977081
- **Project number:** 5P30AG019610-21
- **Recipient organization:** ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
- **Principal Investigator:** Richard J. Caselli
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $747,137
- **Award type:** 5
- **Project period:** — → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9977081

## Citation

> US National Institutes of Health, RePORTER application 9977081, Core B: Clinical Core (5P30AG019610-21). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/9977081. Licensed CC0.

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