# RFA-TS-23-001: Assessment of ALS Risk Factors from ALS TDI's Ongoing Natural History Study (n = 784)

> **NIH ALLCDC R01** · ALS THERAPY DEVELOPMENT FOUNDATION · 2024 · $480,595

## Abstract

Project Summary/Abstract
This application is from investigators at the ALS Therapy Development Institute (ALS TDI) with
expertise in the conduct of longitudinal cohort studies to study people living with amyotrophic
lateral sclerosis and Johns Hopkins University with expertise in data management, statistics,
analysis, and ALS patient advocacy. In addition, we have a consultant, a person living with ALS,
who is a specialist in geographic information software, location intelligence and mapping.
Under the umbrella of ALS TDI’s Precision Medicine Program (PMP) we have two cohorts
totaling more than 800 people with ALS enrolled. Using a secure, web-based portal we collect
extensive natural history data on topics such as head and neck injuries, residential geography,
military service, and much more. We gather data over time by re-administering survey
questions every three months.
We also collect data on clinical data types including:
 · Monthly Self-Administered ALS Functional Rating Scale (FRS)
 · Monthly Voice Recording Data
 · Monthly Accelerometer Based Activity Data
 · Longitudinal Blood Sample Data – Genome Sequencing, Proteomics,
 Transcriptomics, Complete Blood Count, Clinical Chemistry Metabolic Panel
We intend to perform a comprehensive analysis on our natural history data to confirm potential
risk factors or identify new ones. Once potential risk factors are identified or confirmed, we
then plan to further elucidate how these factors affect various features of ALS such as clinical
diagnosis, progression, and outcomes. For example, we have the tools to explore associations
between potential risk factors and progression rates using any or all of the data we have
collected tracking the ALS functional rating scale (ALSFRS-r), longitudinal voice recording data,
and longitudinal activity data. Further, we could compare confirmed risk factors to data
acquired from our blood sample donation program such as DNA sequence analysis data.
Further characterization of ALS risk factors and study of how they contribute to the
pathophysiology of ALS in humans may inform the conception and design of potential ALS
treatments. Also, identifying sub-sets within ALS patient populations may increase the success
of clinical trials in which distinct drugs may be administered to specific sub-groups. In addition,
we may identify risk factors, for example - toxic pollutants, that could be potentially avoided,
essentially preventing the development of ALS in individuals and improving the general health
of the population.

## Key facts

- **NIH application ID:** 10913283
- **Project number:** 5R01TS000341-02
- **Recipient organization:** ALS THERAPY DEVELOPMENT FOUNDATION
- **Principal Investigator:** Fernando Gameiro Vieira
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2024
- **Award amount:** $480,595
- **Award type:** 5
- **Project period:** 2023-09-30 → 2025-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10913283

## Citation

> US National Institutes of Health, RePORTER application 10913283, RFA-TS-23-001: Assessment of ALS Risk Factors from ALS TDI's Ongoing Natural History Study (n = 784) (5R01TS000341-02). Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/grant/nih/10913283. Licensed CC0.

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