ALS Research Collaborative

NCT ID: NCT06885918

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-12

Study Completion Date

2035-01-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ALS Therapy Development Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fernando G Vieira, M.D.

Role: PRINCIPAL_INVESTIGATOR

ALS Therapy Development Institute

Locations

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ALS Therapy Development Institute

Watertown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alan S Premasiri, M.S.

Role: CONTACT

617-441-7200 ext. 7291

Beth Levine

Role: CONTACT

617-441-7200

Facility Contacts

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Alan S Premasiri, M.S.

Role: primary

6174417200 ext. 7291

References

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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.

Reference Type BACKGROUND
PMID: 39707523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37604821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35396385 (View on PubMed)

Related Links

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https://arc.als.net/

ARC Sign Up Page

https://www.als.net/arc/data-commons/

ARC Data Commons Inquiry Page - for researcher access to ARC data

Other Identifiers

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ALSTDI0103

Identifier Type: -

Identifier Source: org_study_id

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