# Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease

> **NIH NIH R01** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2020 · $4,929,565

## Abstract

Project Summary
Based on growing recognition that the long pre-dementia stages of Alzheimer's disease (AD) represent the
optimal time for interventions aimed at modifying the neurobiology of the disease, most recent drug development
programs enroll participants at the preclinical/asymptomatic and prodromal/mild cognitive impairment stages.
However, the timeframe, complexity and expense of the recruitment process and site activation for these
secondary prevention trials are extremely challenging, and indeed site start-up and trial enrollment, in general,
represent the greatest bottleneck for drug development for AD. Thus, there is growing consensus in our field that
we must fundamentally overhaul the current clinical trial recruitment and assessment process for these early
intervention trials. The overarching goal of this proposal is to accelerate current and future secondary prevention
trial enrollment through an innovative, highly efficient approach to identify, evaluate, and enroll appropriate
preclinical and prodromal trial candidates, supported by a new site network with enhanced capacities for more
efficient and effective conduct of AD clinical trials. The specific goal of the current project is to build a large trial-
ready cohort (TRC) for preclinical/prodromal AD (PAD) trials (TRC-PAD). TRC-PAD (n=2000; 1000
preclinical/1000 prodromal AD) will facilitate enrollment into ongoing PAD trials using the ACTC framework. This
application describes a process of connecting existing “feeder” registries and studies to a web based Registry to
capture demographic, genetic and longitudinal clinical and cognitive information on older, non-demented
individuals interested in trials. The Registry data generates risk scores for AD pathology (initially elevated
amyloid in brain, but with methods adaptable to tau pathology and other biomarkers), that allows efficient
selection of candidates for in-person biomarker (initially amyloid PET scans) and clinical assessment. The
results of these assessments, in turn, allow an adaptive statistical algorithm to improve the selection process
moving forward. Individuals with PET scans showing amyloid accumulation in brain (or alternative biomarker
confirmation) are invited to join with semi-annual in-person follow-up within the network of pre-qualified clinical
sites, from which they can be invited to enroll in early stage trials. Overall, the process will dramatically shorten
the timeline for preclinical/prodromal trials, and will address a series of scientific hypotheses to guide further
development in the field.

## Key facts

- **NIH application ID:** 9885998
- **Project number:** 3R01AG053798-02S1
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Paul S. Aisen
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $4,929,565
- **Award type:** 3
- **Project period:** 2017-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9885998

## Citation

> US National Institutes of Health, RePORTER application 9885998, Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (3R01AG053798-02S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9885998. Licensed CC0.

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