Recruiting

Observational Study

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT06581861

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is begin funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.

PREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening/pre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT06581861

Start date

Jul 25, 2024

Status verified date

Jun, 2026

Completion date

Jul 25, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 years or older
2. Capable of providing informed consent
3. Willing to follow study procedures
4. First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
5. Access to a smartphone, computer, or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)

Exclusion Criteria:

1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.
2. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures
3. Clinically significant, unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment

Exclusion Criteria for Participants Undergoing Optional Lumbar Puncture

1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).
2. Allergy to Lidocaine or other local anesthetic agents.
3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
5. Current pregnancy based on participant self-report
6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.

Inclusion Criteria for Genetic Testing Results Sub-study

1. Age 18 years of age or older
2. Capable of providing informed consent
3. Willing to follow study procedures
4. Currently enrolled in the PREVENT ALS Study

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • ALS Symptoms Questionnaire [ Time Frame: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline ]

Central Contacts and Locations

Central contacts

ALL ALS Patient Navigator

602-845-0248info@all-als.org

Locations

University of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Nan Jiang, MD

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Principal Investigator:

Shafeeq Ladha, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

John Ravits, MD

University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Principal Investigator:

Namita Goyal, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Laura Rosow, MD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Laura Foster, MD

Hospital for Special Care

Recruiting

New Britain, Connecticut, United States, 06053

Contacts

Sabine Lebel-Hardenac

shardenack@hfsc.org

Principal Investigator:

Kevin Felice, DO

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 200007

Contacts

Principal Investigator:

Shakti Nayar, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Bjorn Oskarsson, MD

Saint Alphonsus Regional Medical Center

Recruiting

Boise, Idaho, United States, 83704

Contacts

Principal Investigator:

Jackie Whitesell, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Senda Ajroud-Driss, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Cynthia Bodkin, MD

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Principal Investigator:

Nicholas Maragakis, MD

Nih/Ninds

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Principal Investigator:

Justin Kwan, MD

Massachusetts General Brigham

Recruiting

Boston, Massachusetts, United States, 02145

Contacts

Principal Investigator:

James Berry, MD, MPH

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Eva Feldman, MD, PhD

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Ximena Arcila-Londono, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator:

David Walk, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Timothy Miller, MD, PhD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Joseph Americo Fernandes, MD, FAAN

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Mark Garret, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Neil Shneider, MD, PhD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Xiaoyan Li, MD, PhD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Principal Investigator:

Stephen Kolb, MD, PhD

Providence ALS Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Nicholas Olney, MD

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Principal Investigator:

Zachary Simmons, MD

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Principal Investigator:

Terry Heiman-Patterson, MD

Texas Neurology

Recruiting

Dallas, Texas, United States, 75206

Contacts

Principal Investigator:

Daragh Heitzman, MD, FAAN

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Principal Investigator:

Mark Bromberg, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Kelly Gwathmey, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Principal Investigator:

Michael Weiss, MD

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Aug 24, 2026

Last verified

Jun, 2026

Keywords

  • ALS
  • Amyotrophic Lateral Sclerosis
  • Biomarker
  • Observational
  • at-risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2026-08-24.