# Developing processes and tools to assess the safety of anti-amyloid treatments for Alzheimer's disease using real-world data

> **NIH NIH R33** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2024 · $379,646

## Abstract

PROJECT SUMMARY/ABSTRACT
The HCSRN-OAICs AGING Initiative seeks an Alzheimer’s-focused administrative supplement (NOT-AG-23-
032) to 2R33AG057806-06A1 to partner with Harvard Pilgrim Health Care Institute with an overarching goal to
develop the tools and processes required to generate high-quality, real-world evidence on the benefits and
risks of novel therapies for AD, such as lecanemab and future anti-amyloid therapies. We propose the
following specific aims to be accomplished through this supplement: (1) to develop and validate an algorithm,
employing health administrative claims data, for important safety-related events relating to anti-amyloid
therapies including amyloid-related imaging abnormalities (ARIA); and (2) to formulate the processes required
to establish linkages between the CMS registry or other CMS approved registries and health plan data to
address research questions on health outcomes related to use of anti-amyloid therapies not captured by
registries alone. The “Advancing Geriatrics Infrastructure and Network Growth” (AGING) Initiative brings
together the Health Care Systems Research Network (HCSRN) and the Claude D. Pepper Older American
Independence Centers (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 foster
research innovation and translation of research findings into practice through a Multiple Chronic Conditions
(MCCs) Research Innovation, Translation, and Dissemination Core; (2) to foster development of innovative
methods under a Methods, Measures, and Data Core; (3) to foster the career development and success of
new and early-stage investigators through an expanded nation-wide cohort of MCCs Scholars. The proposed
project will expand the toolbox of methodologic approaches and data resources, linkages, and validation
studies 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 lecanemab and other
future novel therapies for Alzheimer’s disease that may receive FDA approval over the coming months and
years, and therefore, will lay the groundwork to provide critical insights into the real-world safety of these novel
therapies to support decisions in their use in patients with Alzheimer’s disease.

## Key facts

- **NIH application ID:** 10938215
- **Project number:** 3R33AG057806-07S1
- **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:** 2024
- **Award amount:** $379,646
- **Award type:** 3
- **Project period:** 2023-09-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10938215

## Citation

> US National Institutes of Health, RePORTER application 10938215, Developing processes and tools to assess the safety of anti-amyloid treatments for Alzheimer's disease using real-world data (3R33AG057806-07S1). Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/grant/nih/10938215. Licensed CC0.

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