Clinical trial NCT06885918: ALS Research Collaborative
Official title: ALS Translational Research Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: ALS Therapy Development Institute
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants can be located anywhere but require internet access.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ALS Functional Rating Scale - Revised (ALSFRS-R)
timeFrame: Monthly, through study completion, an average of 1 year
Secondary outcomes:
measure: Machine-Learning Based Speech Scoring
timeFrame: Monthly, through study completion, an average of 1 year
measure: Limb-based Accelerometry
timeFrame: monthly, through study completion, an average of 6 months
measure: Medications, Supplements, and Clinical Trial Participation Surveys
timeFrame: quarterly, through study completion, an average of 1 year
measure: Social and Environmental Surveys
timeFrame: One-time or quarterly at months 1, 4, 7, 10
Other outcomes:
Locations:
city: Watertown
country: United States
facility: ALS Therapy Development Institute
state: Massachusetts
Study officials:
affiliation: ALS Therapy Development Institute
name: Fernando G Vieira, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.