# Preparing For What Is Next With Aducanumab In Real World Settings

> **NIH NIH R33** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2022 · $434,125

## Abstract

PROJECT SUMMARY/ABSTRACT
The HCSRN-OAICs AGING Initiative seeks an Alzheimer’s-focused administrative supplement (NOT-AG-21-
018) to R33 AG057806 to partner with Harvard Pilgrim Health Care Institute to address the following
overarching goal: to develop a “shovel-ready” master protocol with detailed analytic approaches that can be
executed efficiently on administrative claims data to address the following questions: (1) Among those who are
prescribed aducanumab, is use limited to indications specified in the label?; (2) What are the characteristics of
patients prescribed aducanumab and what can be ascertained about equity and inclusion in relation to early
use of this therapy?; (3) How often are patients prescribed aducanumab who have potential contraindications
to therapy, such as being on anticoagulants in view of the risk of brain microhemorrhages?; (4) What
diagnostic testing precedes initiation of therapy (e.g., MRI, PET scan, lumbar puncture)?; (5) What are the
patterns of monitoring with imaging subsequent to initiation of aducanumab?; (6) How frequently do patients
discontinue treatment and at what point after initiation?; (7) What health outcomes are most meaningful to
patients and their care partners (recognizing that aducanumab is prescribed to make things “less worse” and
not better)?; and (8) Do patients or their care partners perceive a change in clinical course following initiation of
aducanumab? The “Advancing Geriatrics Infrastructure and Network Growth” (AGING) Initiative brings
together the Health Care Systems Research Network (HCSRN) and the OAICs to advance an interdisciplinary
research agenda focused on older adults with multiple chronic conditions (MCCs). The specific aims under the
AGING Initiative R33 are: (1) to expand on and further develop innovative methods related to measurement
and analytics, observational research, and pragmatic clinical trial design and implementation, to inform the
development and testing of novel interventions that improve the care and outcomes of older persons with
MCCs; (2) to foster the career development and success of new and early-stage investigators, including
underrepresented minorities; (3) to create a new core function as part of an elaborated infrastructure that
promotes patient-centered research by engaging patients and care partners in all stages of the research
process; and (4) to fund a series of “P-2-R” (“Pilot-to-R award”) grants. The proposed project will expand the
toolbox of methodologic approaches and data resources that can be applied to the portfolio of research
conducted under and fostered by the R33. The expectation is that the efforts undertaken through this
supplement will be applicable to other novel therapies for Alzheimer’s disease that may receive FDA approval
over the coming months and years and will lay the groundwork for a future comparative effectiveness study
which emulates a randomized controlled trial.

## Key facts

- **NIH application ID:** 10497313
- **Project number:** 3R33AG057806-05S1
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** JERRY H GURWITZ
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $434,125
- **Award type:** 3
- **Project period:** 2018-08-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10497313

## Citation

> US National Institutes of Health, RePORTER application 10497313, Preparing For What Is Next With Aducanumab In Real World Settings (3R33AG057806-05S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10497313. Licensed CC0.

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