# Pilot Studies Core

> **NIH NIH U54** · BROWN UNIVERSITY · 2024 · $470,907

## Abstract

PROJECT SUMMARY
The lack of research testing interventions targeting patients with dementia (PWD) and their caregivers in real-
world settings hinders the ability of health care systems (HCS) to adequately care for this rapidly expanding
and highly vulnerable population. Pragmatic clinical trials that are embedded in HCS (ePCTs) can address this
shortcoming. However, ePCTs are complex, require specific methodologies, skilled investigators, close
partnerships with HCS, robust data infrastructures, and special regulatory and ethical considerations. Over the
past several years, individual teams of investigators have begun to acquire experience conducting ePCTs
among PWD and their caregivers. Their experience has reinforced how indispensable a pilot phase is to inform
the successful conduct of the full ePCT. The Pilot Core of the National Institute on Aging (NIA) AD/ADRD HCS
Research Collaboratory will therefore solicit, and fund over 30 pilot ePCTs and then guide all aspects of these
studies throughout their lifecycles. The Core will 1) create a robust and transparent review process, 2) provide
active technical assistance to increase the success of funded pilots, 3) promote the development of
investigator expertise and leverage experiences across projects through structured trainings, and 4) facilitate
the adaptation of pilot tested interventions into well-designed ePCTs. Ultimately, this will lead to full-scale
ePCTs, and simultaneously build investigator capacity to conduct ePCTs. The Pilot Core will be led by Dr.
Abraham Brody, PhD, RN, FAAN, Associate Professor of Nursing and Medicine at New York University, a
nurse researcher with significant experience in dementia and ePCTs, who will work with a highly skilled,
interdisciplinary, Executive Committee. The Pilot Core will leverage the overall infrastructure of the NIA
AD/ADRD HCS Collaboratory to achieve: Aim 1: Solicit, rigorously review, select, and fund projects that will
lead to future full-scale ePCTs focused on PWD and their caregivers; Aim 2: Provide the monitoring,
mentorship, and resources to ensure rigorous, timely completion of pilot milestones, and effective sharing of
pilot data and results; Aim 3: Promote the expertise of pilot project investigators in conducting ePCTs with
PWD and their caregivers by: 1. Integrating them into the activities of the AD/ADRD Collaboratory and Working
Group Cores, 2. Providing access to structured training opportunities led by the Training Core, and 3. Holding
an annual Scientific Conference in Years 3-5 to present and share research and experiences; Aim 4: Assist
pilot projects to transform completed pilot projects into successfully funded full-scale ePCTs in PWD and/or
their caregivers. IMPACT: The NIA AD/ADRD Collaboratory Pilot Core will assist researchers to investigate
practical interventions that can be implemented in HCS that serve over 5 million PWD and their caregivers.
These pilots will seed multiple full-scale ePCTs aimed at improving the ...

## Key facts

- **NIH application ID:** 11092543
- **Project number:** 3U54AG063546-05S2
- **Recipient organization:** BROWN UNIVERSITY
- **Principal Investigator:** Abraham Aizer Brody
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $470,907
- **Award type:** 3
- **Project period:** 2019-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11092543

## Citation

> US National Institutes of Health, RePORTER application 11092543, Pilot Studies Core (3U54AG063546-05S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11092543. Licensed CC0.

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