ALS Research Collaborative

NCT06885918 | Recruiting

• 1 other identifier: ALSTDI0103
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.

Conditions

Amyotrophic Lateral Sclerosis; ALS (Amyotrophic Lateral Sclerosis); ALS With Frontotemporal Dementia (ALS/FTD); Motor Neuron Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Keywords

ARC; ALS Research Collaborative; ALS TDI; ALS Therapy Develeopment Institute

Outcome Measures

Primary Outcomes (1)

• ALS Functional Rating Scale - Revised (ALSFRS-R)

  A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale.

  Monthly, through study completion, an average of 1 year

Secondary Outcomes (4)

• Machine-Learning Based Speech Scoring

  Monthly, through study completion, an average of 1 year

• Limb-based Accelerometry

  monthly, through study completion, an average of 6 months

• Medications, Supplements, and Clinical Trial Participation Surveys

  quarterly, through study completion, an average of 1 year

• Social and Environmental Surveys

  One-time or quarterly at months 1, 4, 7, 10

Study Arms (3)

Person living with ALS/MND

An adult over the age of 18, that has received a diagnosis of ALS or other Motor Neuron Disease from a practicing physician.

Asymptomatic gene carrier

An adult over the age of 18 who does not have symptoms of ALS and carries a mutation known to be associated with ALS

Healthy Volunteer

An adult over the age of 18 who does not have any biological connection to ALS or other Motor Neuron Disease, and no significant health problems.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants can be located anywhere but require internet access.

You may qualify if:

• years of age or older
• Can communicate in written English
• Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation

You may not qualify if:

• Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.

Sponsors & Collaborators

• ALS Therapy Development Institute: lead

Study Sites (1)

ALS Therapy Development Institute

Watertown, Massachusetts, 02472, United States

RECRUITING

Related Publications (3)

• Straczkiewicz M, Burke KM, Calcagno N, Premasiri A, Vieira FG, Onnela JP, Berry JD. Free-living monitoring of ALS progression in upper limbs using wearable accelerometers. J Neuroeng Rehabil. 2024 Dec 21;21(1):223. doi: 10.1186/s12984-024-01514-7.

  PMID: 39707523 BACKGROUND

• Gupta AS, Patel S, Premasiri A, Vieira F. At-home wearables and machine learning sensitively capture disease progression in amyotrophic lateral sclerosis. Nat Commun. 2023 Aug 21;14(1):5080. doi: 10.1038/s41467-023-40917-3.

  PMID: 37604821 BACKGROUND

• Vieira FG, Venugopalan S, Premasiri AS, McNally M, Jansen A, McCloskey K, Brenner MP, Perrin S. A machine-learning based objective measure for ALS disease severity. NPJ Digit Med. 2022 Apr 8;5(1):45. doi: 10.1038/s41746-022-00588-8.

  PMID: 35396385 BACKGROUND

Related Links

• ARC Sign Up Page
• ARC Data Commons Inquiry Page - for researcher access to ARC data

Biospecimen

Retention: SAMPLES WITH DNA

Fibroblasts, Serum, Plasma, Whole Blood

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; AIDS-Related Complex

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Fernando G Vieira, M.D.

  ALS Therapy Development Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan S Premasiri, M.S.

CONTACT

617-441-7200; apremasiri@als.net

Beth Levine

CONTACT

617-441-7200; blevine@als.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 20, 2025
• Study Start: September 12, 2014
• Primary Completion (Estimated): January 31, 2035
• Study Completion (Estimated): January 31, 2035
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)