ALS Research Collaborative

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; ALS (Amyotrophic Lateral Sclerosis); ALS with Frontotemporal Dementia (ALS/FTD); Motor Neuron Disease; Motor Neuron Disease, Amyotrophic Lateral Sclerosis

• Registration Number: NCT06885918
• Lead Sponsor: ALS Therapy Development Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-12
• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2035-01-31
• Study Completion: 2035-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 18 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALS Functional Rating Scale - Revised (ALSFRS-R)	Monthly, through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Machine-Learning Based Speech Scoring	Monthly, through study completion, an average of 1 year	Participants submit a scripted voice recording of 5 different, short phrases that are then scored by a machine-learning based algorithm that assess dysarthria on a non-integer scale of 0 (fully impaired) to 4 (normal speech)
Limb-based Accelerometry	monthly, through study completion, an average of 6 months	Participants wear four, ActiGraph devices on each limb. Passive and active (video-directed) wear time data is collected over one week. The devices measure acceleration and represent the strength of each limb during movement. Outputs include activity counts and raw acceleration data.
Medications, Supplements, and Clinical Trial Participation Surveys	quarterly, through study completion, an average of 1 year	Participants complete questionnaires describing usage information about medications and supplements they have taken and are currently taking, as well as clinical trial participation.
Social and Environmental Surveys	One-time or quarterly at months 1, 4, 7, 10	Participants complete questionnaires about their familial, educational, and geographical background, as well as lifestyle habits and past medical conditions and injuries. These are non-current factors that may have an affect on current health outcomes.

Trial Locations

Locations (1)

ALS Therapy Development Institute; 🇺🇸 Watertown, Massachusetts, United States