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Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
NCT05137665 · View on ClinicalTrials.gov ↗
Study Summary
The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.
Conditions Studied
Study Locations (12)
Other
- Instituto Roosevelt — Bogotá
- CHALS-CCT UPR MScience — San Juan
Arizona
- Barrow Neurological Institute — Phoenix
California
- University of California San Diego — San Diego
District of Columbia
- Georgetown University — Georgetown
Florida
- Mayo Clinic — Jacksonville
Illinois
- Northwestern University — Chicago
Massachusetts
- Massachusetts General Hospital — Boston
Missouri
- Washington University — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2031-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05137665
The ClinicalTrials.gov registry entry for NCT05137665 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Target ALS Foundation, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05137665 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Other, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05137665 about?
NCT05137665 is a clinical study titled "Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures". The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amy...
What is the current status of trial NCT05137665?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2021-06-01. Estimated completion is 2031-12-31.
What conditions does trial NCT05137665 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Movement Disorders, Motor Neuron Disease, Degenerative Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT05137665?
This trial is sponsored by Target ALS Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05137665 being conducted?
This trial has 12 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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