# UNDERSTANDING HOW THE STUDY PARTNER REQUIREMENT IMPACTS THE DISCOVERY AND TRANSLATION OF PRECLINICAL ALZHEIMERS DISEASE

> **NIH NIH K01** · UNIVERSITY OF PENNSYLVANIA · 2021 · $127,305

## Abstract

The applicant’s career goal is to be an independent investigator whose research assures the successful,
ethically-informed translation of the preclinical Alzheimer’s disease construct into clinical practice. As a first
step toward that goal, the applicant seeks to answer a fundamental question: how does the requirement that
participants in preclinical Alzheimer’s disease trials enroll with a knowledgeable informant or “study partner”
affect diverse recruitment and the study partners themselves? This question is important because until it is
answered, it will be difficult to meet the overarching goal of the NIA’s National Strategy for Recruitment and
Participation in Alzheimer’s Disease Clinical Research, which is to engage broad segments of the population in
research to better understand and eventually cure Alzheimer’s disease. The overall objective in this
application is to understand the effects of the study partner requirement in preclinical Alzheimer’s disease
research. The central hypothesis is that race, gender, and the nature of the relationship between the
participant and the study partner (i.e., spousal/non-spousal) affect both the availability of a study partner to
participate and the study partner’s research experience. The rationale for the proposed research is that
understanding the effects of the study partner requirement has the potential to facilitate diverse recruitment
and inform the future of biomarker disclosure in clinical practice. Guided by strong preliminary data, the
applicant will test this hypothesis by pursuing three specific aims: (1) Describe how a study partner’s
knowledge of a preclinical Alzheimer’s disease trial participant’s brain amyloid status influences the study
partner’s psychological well-being and planning for the future, and examine the differences by race, gender,
and relationship. (2) Characterize the role of the study partner in the preclinical Alzheimer’s disease trial
enrollment decision, and examine the differences by race, gender, and relationship. (3) Identify psychosocial
determinants associated with the intention to ask someone to serve as a study partner in a preclinical
Alzheimer’s disease trial, the beliefs associated with those determinants, and the differences in intention by
race, gender, and relationship. Under the first and second aims, individual interviews, which have already been
established as feasible in the applicant’s hands, will be used to understand key aspects of the study partner
experience. Under the third aim, the applicant will conduct a nationally-representative survey of older adults.
This approach is innovative because it departs from the status quo by focusing on study partners rather than
exclusively on preclinical Alzheimer’s disease trial participants. The proposed research is significant because
it is expected to inform the design of preclinical Alzheimer’s disease trials to enhance recruitment and
biomarker disclosure practices. The training activities during the ...

## Key facts

- **NIH application ID:** 10134186
- **Project number:** 5K01AG064123-03
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Emily Largent
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $127,305
- **Award type:** 5
- **Project period:** 2019-08-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10134186

## Citation

> US National Institutes of Health, RePORTER application 10134186, UNDERSTANDING HOW THE STUDY PARTNER REQUIREMENT IMPACTS THE DISCOVERY AND TRANSLATION OF PRECLINICAL ALZHEIMERS DISEASE (5K01AG064123-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10134186. Licensed CC0.

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