# Comparison of Demographics: National Amyotrophic Lateral Sclerosis Registry and Clinical Trials Data

## TL;DR

This study compares the demographics of participants in an ALS registry and clinical trials data to identify differences in age and diversity.

## Contribution

The study highlights demographic disparities in ALS research populations to improve patient inclusion and study generalizability.

## Key findings

- PRO-ACT had more younger participants and fewer older ones compared to the Registry.
- The Registry had higher minority representation, while PRO-ACT had significant missing race data.
- Registry participants had a longer delay between symptom onset and diagnosis compared to PRO-ACT participants.

## Abstract

To characterize the participant demographics in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database compared with the web-portal National Amyotrophic Lateral Sclerosis (ALS) Registry (the Registry).

Demographics and ALS symptom information were compared between the self-reported registrant data in the Registry web portal (2010–2021) and the latest available PRO-ACT data (updated August 2022), which is a collection of clinical trials data.

Greater percentages of younger (≤ 59 years old) but smaller percentages of older (60 + years old) participants were represented in PRO-ACT compared to Registry. Enrollment for minority race groups was greater in the Registry portal data, but race information was largely missing/unknown in PRO-ACT database. Median age at the time of diagnosis and age at the time of symptom onset were significantly higher for Registry enrollees compared to the participants of PRO-ACT. Symptom onset sites were similarly reported, but duration between self-noted symptom onset and diagnosis was slight, but significantly longer for the Registry enrollees (11 vs. 9 months). Hispanic were as likely as non-Hispanic to participate in research studies, based on the Registry data.

There was a notable difference in the age distribution and minority representation of enrollees between the PRO-ACT and Registry study populations. Age distribution in the PRO-ACT database skewed to a younger and less diverse cohort. Despite the clinical heterogeneity and complex disease mechanism of ALS, identifying the underrepresented demographic niche in the PRO-ACT and Registry study populations can help improve patient participation and criteria for patient selection to enhance generalizability.

The online version contains supplementary material available at 10.1007/s40615-024-02047-4.