# Alzheimer's Clinical Trials Consortium (ACTC)

> **NIH NIH U24** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2024 · $28,436,169

## Abstract

SUMMARY. This is a multi-PI application renewing the U24 Cooperative Agreement to sustain and expand the
NIA’s state-of-the-art Alzheimer Clinical Trial Consortium (ACTC) responsible for conducting academic clinical
trials across the continuum of Alzheimer’s disease (AD). This ACTC will continue to leverage the depth and
breadth of AD clinical research teams at USC, Harvard, and the Mayo Clinic, as well as the considerable
experience of investigators at 35 expert AD trial sites. We aim to sustain the optimized infrastructure that
efficiently develops and conducts high quality NIH supported clinical trials in AD and related dementias, while
addressing the need for Justice, Equity, Diversity, and Inclusion (JEDI) by incorporating JEDI principles across
all consortium infrastructure, activities, and studies. Building on our first five years of experience, we will utilize
streamlined contracting processes, a centralized IRB with a specific focus on neurodegenerative diseases, and
incorporate state-of-the-art informatics and statistical analyses. We will effectively manage performance of
clinical trial sites, while identifying, mentoring and supporting new trial sites to improve access to clinical trials.
We will foster continued innovation in AD trial design, providing expertise on novel cognitive, imaging, and
biomarker outcomes to support future ACTC trial applications. We will evaluate promising exploratory
measures imbedded in our current trials, such as Tau PET imaging and computerized cognitive testing, and
work to incorporate these measures into a robust platform for future Proof of Concept (POC) trials to rapidly
assess signals of efficacy. The ACTC Coordinating Center will leverage the highly experienced teams in
Clinical Operations, Data Systems and Management, and Biostatistics at USC. The MRI Unit, led by Mayo,
and PET Unit, led by Harvard and UC Berkeley, will capitalize on unparalleled experience with multi-site
protocols through ADNI, the A4 Study, and multiple ongoing clinical trials. The Clinical Outcome Instrument
and Biomarkers Units will leverage world-class expertise from Mayo, Harvard, and USC to incorporate both
standard and novel outcome measures in future trial designs. The new IDEA-CT Unit will provide training and
leadership opportunities to young clinical investigators to facilitate continued innovation in trial design, and
catalyze the next generation of AD clinical trials.
The experts comprising this infrastructure provide the highest levels of expertise to design and conduct trials
across the full continuum of AD, from primary prevention initiatives to combination trials for advanced
symptomatic stages. We will build on our successes with public/private partnerships and continue to
strengthen our strategic alliances to conduct large scale trials, while also supporting novel approaches to
smaller investigator-initiated POC studies that will better inform Phase 3 decision-making. A program
facilitating the longitudinal fo...

## Key facts

- **NIH application ID:** 10930090
- **Project number:** 5U24AG057437-07
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Paul S. Aisen
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $28,436,169
- **Award type:** 5
- **Project period:** 2017-12-02 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10930090

## Citation

> US National Institutes of Health, RePORTER application 10930090, Alzheimer's Clinical Trials Consortium (ACTC) (5U24AG057437-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10930090. Licensed CC0.

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