Creating a biorepository of biofluids and clinical data for ALS research

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish a biorepository of longitudinal biofluids, including blood, cerebrospinal fluid, and urine, linked to genetic and clinical information from patients with Amyotrophic Lateral Sclerosis (ALS) and healthy controls. Over a five-year period, 800 ALS patients and 200 healthy participants will be enrolled from various global sites. Participants will undergo regular clinical assessments and provide biofluid samples, which will be stored in a de-identified manner for future research. The goal is to facilitate the identification and validation of ALS biomarkers to enhance drug development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• University of California San Diego
  San Diego, California, United States Recruiting
• Georgetown University
  Georgetown, District of Columbia, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Laura Dugom, MPH
• Email: laura.dugom@targetals.org
• Phone: 919-440-2073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.