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

Target ALS Foundation, Inc. · NCT05137665

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
10
Study start
June 1, 2021
Record last updated
November 21, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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: Amyotrophic Lateral Sclerosis; Movement Disorders; Degenerative Disorder; Motor Neuron Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Barrow Neurological Institute

    Phoenix, AZ 85013

    Site contact: Whitney Dailey, MS · 602-406-7804 · whitney.dailey@dignityhealth.org

  • University of California San Diego

    San Diego, CA 92121

    Site contact: Gil Gutierrez · grg005@health.ucsd.edu

  • Georgetown University

    Georgetown, DC 20007

    Site contact: Cassie Holmes, NP · cjh278@georgetown.edu

  • Mayo Clinic

    Jacksonville, FL 32224

    Site contact: Huy Tran · tran.huy1@mayo.edu

  • Northwestern University

    Chicago, IL 60611

    Site contact: Arleen Matos · (312) 503-0748 · arleen.matos@northwestern.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Lada Filippov · 617-724-7048 · lfilippov@mgh.harvard.edu

  • Washington University

    St Louis, MO 63110

    Site contact: Nathan Budden · budden@wustl.edu

  • Columbia University

    New York, NY 10032

    Site contact: Ben Hoover · bnh2119@cumc.columbia.edu

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Hala Khan, MPH · Hala.Khan@bcm.edu

  • University of Washington

    Seattle, WA 98195

    Site contact: Kaycie Opiyo · tkaycie@uw.edu

Study contacts (from the official record)

  • Laura Dugom, MPH · 919-440-2073 · laura.dugom@targetals.org
  • Robert Bowser, PhD · 602-406-8989 · robert.bowser@dignityhealth.org
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Target ALS Biomarker Study; Longitudinal Biofluids, Clinical… (NCT05137665) | Bored Studies