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NCT Number: NCT06885918

ALS Research Collaborative

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.

Recruiting

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Key information

Conditions

Amyotrophic Lateral Sclerosis AIDS-Related Complex ALS (Amyotrophic Lateral Sclerosis) ALS With Frontotemporal Dementia (ALS/FTD) Blood-Borne Infections Central Nervous System Diseases Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Diseases Motor Neuron Disease Motor Neuron Disease, Amyotrophic Lateral Sclerosis Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Spinal Cord Diseases TDP-43 Proteinopathies Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ALS Therapy Development Institute

Watertown, Massachusetts, 02472, United States

Location status: Recruiting

Location contact

Alan S Premasiri, M.S.

CONTACT

[email protected]

6174417200 ext. 7291

Fernando G Vieira, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. ALS Functional Rating Scale - Revised (ALSFRS-R)

    Time frame: 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 outcomes

  1. Machine-Learning Based Speech Scoring

    Time frame: 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)

  2. Limb-based Accelerometry

    Time frame: 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.

  3. Medications, Supplements, and Clinical Trial Participation Surveys

    Time frame: 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.

  4. Social and Environmental Surveys

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alan S Premasiri, M.S.

CONTACT

[email protected]

617-441-7200 ext. 7291

Beth Levine

CONTACT

[email protected]

617-441-7200

Sponsors and collaborators

Lead sponsor

ALS Therapy Development Institute

Other

Registry information

Official study title

ALS Translational Research Program

Acronym: ARC

Important dates

Study start
2014
Primary completion
2035
Study completion
2035
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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