<table class="infobox infobox-institution"> <tr> <th class="infobox-header" colspan="2">ALS Clinical Trials Consortium (NEALS)</th> </tr> <tr> <td class="label">Location</td> <td>Multiple sites across the United States and internationally</td> </tr> <tr> <td class="label">Type</td> <td>Clinical Trial Network</td> </tr> <tr> <td class="label">Founded</td> <td>1997 (NEALS); coordinated consortium formed 2010s</td> </tr> <tr> <td class="label">Funding</td> <td>National Institute of Neurological Disorders and Stroke (NINDS), ALS Association, MDA</td> </tr> <tr> <td class="label">Website</td> <td><a href="https://www.neals.org" target="_blank">neals.org</a></td> </tr> <tr> <td class="label">Focus Areas</td> <td>[Amyotrophic Lateral Sclerosis](/diseases/als), Clinical Trials, Therapeutic Development</td> </tr> <tr> <td class="label">Parent Institution</td> <td>[NIH - National Institutes of Health](/institutions/nih)</td> </tr> </table>
ALS Clinical Trials Consortium (NEALS)
The ALS Clinical Trials Consortium refers to the coordinated network of clinical trial sites and researchers dedicated to accelerating ALS therapeutic development. In the United States, this function is primarily served by NEALS (Network of Excellence for ALS), a global network of researchers, clinicians, and people with ALS working together to accelerate the discovery and delivery of effective treatments[@neals].
Overview
...
<table class="infobox infobox-institution"> <tr> <th class="infobox-header" colspan="2">ALS Clinical Trials Consortium (NEALS)</th> </tr> <tr> <td class="label">Location</td> <td>Multiple sites across the United States and internationally</td> </tr> <tr> <td class="label">Type</td> <td>Clinical Trial Network</td> </tr> <tr> <td class="label">Founded</td> <td>1997 (NEALS); coordinated consortium formed 2010s</td> </tr> <tr> <td class="label">Funding</td> <td>National Institute of Neurological Disorders and Stroke (NINDS), ALS Association, MDA</td> </tr> <tr> <td class="label">Website</td> <td><a href="https://www.neals.org" target="_blank">neals.org</a></td> </tr> <tr> <td class="label">Focus Areas</td> <td>[Amyotrophic Lateral Sclerosis](/diseases/als), Clinical Trials, Therapeutic Development</td> </tr> <tr> <td class="label">Parent Institution</td> <td>[NIH - National Institutes of Health](/institutions/nih)</td> </tr> </table>
ALS Clinical Trials Consortium (NEALS)
The ALS Clinical Trials Consortium refers to the coordinated network of clinical trial sites and researchers dedicated to accelerating ALS therapeutic development. In the United States, this function is primarily served by NEALS (Network of Excellence for ALS), a global network of researchers, clinicians, and people with ALS working together to accelerate the discovery and delivery of effective treatments[@neals].
Overview
| Attribute | Details | |-----------|---------| | Full Name | NEALS (Network of Excellence for ALS) | | Type | Clinical Trial Consortium | | Founded | 1997 | | Headquarters | Boston, MA (Massachusetts General Hospital) | | Coverage | 100+ clinical sites globally | | Focus | ALS and frontotemporal dementia (FTD) |
Mission and Objectives
NEALS' mission is to accelerate the development of effective treatments for ALS by:
Clinical Trial Infrastructure: Providing standardized protocols and site coordination
Patient Recruitment: Enhancing enrollment through outreach and awareness
Data Sharing: Creating harmonized data collection and open-access repositories
Biomarker Development: Supporting identification and validation of ALS biomarkers
Training: Developing the next generation of ALS clinical researchers
Regulatory Engagement: Working with FDA on innovative trial designs
History
Foundation and Growth
The Northeast ALS (NEALS) Consortium was established in 1997 by Dr. Michael Benatar and Dr. Matthew B. Harms at the Massachusetts General Hospital in Boston. What began as a regional network of academic medical centers in the northeastern United States has grown into one of the most influential ALS clinical trial networks globally[@nealsa].
Key milestones:
| Year | Milestone | |------|-----------| | 1997 | NEALS founded as regional consortium | | 2000s | Expanded to national coverage | | 2010 | Integrated with NIH ALS clinical research | | 2015 | Launch of adaptive platform trials | | 2020 | Remote trial capabilities expanded |
Structure and Leadership
Administrative Structure
Executive Director: Dr. Jeremy M. Shefner (University of Rochester)
Co-Principal Investigators: Dr. Matthew B. Harms, Dr. Michael Benatar
Scientific Advisory Board: Leading ALS researchers internationally
Patient Advisory Board: People living with ALS and caregivers
Clinical Trial Sites
NEALS encompasses over 100 clinical sites across North America, Europe, and Asia-Pacific, including:
Major academic medical centers
University-affiliated research hospitals
Specialized ALS clinics
International partner sites
Key Functions
Clinical Trial Operations
NEALS provides comprehensive infrastructure for ALS clinical trials:
| Function | Description | |----------|-------------| | Site Certification | Standardized training and certification for trial sites | | Protocol Development | Expert input on trial design and endpoints | | Patient Recruitment | Centralized databases and outreach programs | | Data Management | Standardized data collection and quality control | | Regulatory Support | IND filing and FDA engagement |
Research Programs
Therapeutic Focus Areas
Neuroprotective Agents: Compounds to protect motor [neurons](/entities/neurons) from degeneration
Gene Therapy: AAV-based treatments for genetic forms of ALS (SOD1, [C9orf72](/entities/c9orf72), FUS)
Antisense Oligonucleotides: RNA-targeted therapies (e.g., tofersen for SOD1)
Small Molecule Drugs: Metabolic modulators, anti-inflammatory agents
Cell-Based Therapies: Stem cell approaches and regenerative medicine
Biomarker Initiatives
Biofluid Biomarkers: [Neurofilament light](/biomarkers/neurofilament-light-chain-nfl) chain (NfL), neurofilament heavy chain (NfH)
Neuroimaging: MRI and PET biomarkers
Electrophysiology: Motor unit number estimation (MUNE)
Digital Biomarkers: Wearable devices and remote monitoring
Major Clinical Trials
Completed Landmark Trials
Edaravone (Radicava) Trials: Contributed to FDA approval (2017) — first new ALS drug in 22 years[@edaravone]