# Clinic-based Multicenter ALS Natural History Data Collection

> **NIH FDA R01** · UNIVERSITY OF MINNESOTA · 2024 · $1,500,000

## Abstract

Project summary/abstract
Amyotrophic lateral sclerosis (ALS) is a universally disabling and fatal neurological condition.
Current treatments have only modest benefit. Development of effective therapeutics is
hampered in part by inadequate knowledge of ALS natural history. Though valuable, existing
ALS registries have either large samples sizes but limited clinical information, focus on relatively
small subsets of the ALS population, or provide information from a relatively brief period.
However, as a part of routine clinical care, ALS multidisciplinary clinics (MDCs) develop a rich
natural history dataset from all ALS patients, and most people living with ALS are seen at
MDCs. We have built a combined, de-identified natural history dataset from over 1,700 ALS
patients from 9 MDCs, with racial representation that is reflective of the ALS population at large
and broad geographic representation as well. We offer enrollment to all patients at our clinics.
We will build on our multicenter, longitudinal, prospective MDC dataset in collaboration with
industry and the ALS patient community to provide information critical for clinical trial
development and post-marketing evaluation. Specifically, we will do the following: record
clinically relevant baseline characteristics and serum neurofilament light (NfL) measurements at
enrollment as well as validated longitudinal measures of disease progression including
ALSFRS-R and disease staging, respiratory vital capacity, speaking rate and 10 meter walk test
(Aim 1), record disease milestones based upon patient-reported outcomes, durable medical
equipment orders in the electronic health record, and other events such as dates of
gastrostomy, hospitalizations, and death (Aim 2), and model time to events using baseline
characteristics as well as retrospective and prospective longitudinal data (Aim 3). We have
demonstrated the ability to enroll the vast majority of patients seeking care in our clinics so as to
best represent the ALS population. Baseline characteristics will include ALS phenotype and
results of genetic testing. Datasets will be made available to academic and industry
investigators to advance ALS care, drug development, and outcomes research. We will expand
existing engagement from industry and other stakeholders to include an advisory panel of
people living with ALS and will encourage opportunities for data dissemination through these
existing relationships and publications.

## Key facts

- **NIH application ID:** 11183152
- **Project number:** 3R01FD007630-01S2
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** David Walk
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $1,500,000
- **Award type:** 3
- **Project period:** 2022-09-20 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11183152

## Citation

> US National Institutes of Health, RePORTER application 11183152, Clinic-based Multicenter ALS Natural History Data Collection (3R01FD007630-01S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11183152. Licensed CC0.

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