Collects biofluid samples and clinical data from people with ALS and healthy adults
Builds a shared bank of blood, spinal fluid and urine samples from people with ALS.
Plain-language title generated from the registry record
Registry title: Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures
Key facts
- Where
- Boston, Chicago, Georgetown, Houston, Jacksonville, New York, Phoenix, San Diego, Seattle, and St Louis, United StatesSee the 10 sites
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- Georgetown UniversityGeorgetown, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Mayo ClinicJacksonville, United StatesTaking people
- Columbia UniversityNew York, United StatesTaking people
- Barrow Neurological InstitutePhoenix, United StatesTaking people
- University of California San DiegoSan Diego, United StatesTaking people
- University of WashingtonSeattle, United StatesTaking people
- Washington UniversitySt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Target ALS Foundation, Inc.
- Trial code
- NCT05137665
- Record updated
- 21 November 2025
- Original description
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.Read full original descriptionShow less
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 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.
ALS Participants:; Age 18 or older; A diagnosis of ALS in accordance with Gold Coast criteria; Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening; Ability to provide informed consent and understand the purpose and risks of the study; Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator; Healthy Control Participants:; Age 18 or older; No history of neurological disease, in the opinion of the Principal Investigator; No known ALS- associated genetic mutations at the time of consent; Ability to provide informed consent and understand the purpose and risks of the study; Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.