PREVENT ALL ALS Study

Last updated: April 14, 2025
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Scar Tissue

Myasthenia Gravis (Chronic Weakness)

Treatment

N/A

Clinical Study ID

NCT06581861
2024P001131
1OT2NS136939
1OT2NS136938
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofwhether ALS or FTD has actually been symptomatic in the family) OR First-degreerelative of an individual with ALS and/or FTD in a family with a "compelling familyhistory" of ALS/FTD, regardless of whether genetic testing has occurred insymptomatic family members. A "compelling family history" is defined as a pedigreewith at least 2 close relatives who had ALS or FTD, with at least one of thosefamily 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 issufficient)

Exclusion

Exclusion Criteria:

  1. Evidence of neurological signs or symptoms concerning for ALS of FTD, at thediscretion of the site investigator which will be communicated to the applicantalong with referral for appropriate clinical follow-up.

  2. Significant cognitive impairment, clinical dementia, or unstable psychiatricillness, including psychosis, active suicidal ideation, suicide attempt, oruntreated major depression <= 90 days (about 3 months) of screening, which in theopinion of the Investigator would interfere with the study procedures

  3. Clinically significant, unstable medical condition (e.g., cardiovascularinstability, systemic infection, untreated thyroid dysfunction, malignant andpotentially progressive cancer) that would render the participant unlikely to beable 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 siteinvestigator (i.e., bleeding disorder, a skin infection at or near the LP site,known or suspected intracranial or intraspinal tumor or other cause of increasedintracranial pressure).

  2. Allergy to Lidocaine or other local anesthetic agents.

  3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81mg) that cannot be safely withheld prior to lumbar puncture.

  4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renalfailure.

  5. Current pregnancy based on participant self-report

  6. Clinical judgement of the site investigator that the participant would be unable toundergo 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

Total Participants: 600
Study Start date:
July 25, 2024
Estimated Completion Date:
July 25, 2029

Connect with a study center

  • CHALS-CCT, University of Puerto Rico, Medical Sciences Campus

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • University of California San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Hospital for Special Care

    New Britain, Connecticut 06053
    United States

    Active - Recruiting

  • Georgetown University

    Washington, District of Columbia 200007
    United States

    Active - Recruiting

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • John Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Nih/Ninds

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Massachusetts General Brigham

    Boston, Massachusetts 02145
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • Providence ALS Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Texas Neurology

    Dallas, Texas 75206
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

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