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Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures

Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures

About This Trial

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.

Who May Be Eligible (Plain English)

ALS Participants: 1. Age 18 or older. 2. A diagnosis of ALS in accordance with Gold Coast criteria. 3. 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. 4. Ability to provide willing to sign a consent form and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator. Healthy Control Participants: 1. Age 18 or older. 2. No history of neurological disease, in the opinion of the Principal Investigator. 3. No known ALS- associated genetic mutations at the time of consent. 4. Ability to provide willing to sign a consent form and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

ALS Participants: 1. Age 18 or older. 2. A diagnosis of ALS in accordance with Gold Coast criteria. 3. 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. 4. Ability to provide informed consent and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator. Healthy Control Participants: 1. Age 18 or older. 2. No history of neurological disease, in the opinion of the Principal Investigator. 3. No known ALS- associated genetic mutations at the time of consent. 4. Ability to provide informed consent and understand the purpose and risks of the study. 5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.

Locations (12)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of California San Diego

San Diego, California, United States

Georgetown University

Georgetown, District of Columbia, United States

Mayo Clinic

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Columbia University

New York, New York, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Instituto Roosevelt

Bogotá, Colombia

CHALS-CCT UPR MScience

San Juan, Puerto Rico