ASSESS ALL ALS Study

Last updated: March 31, 2025
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT06578195
2024P001132
1OT2NS136939
1OT2NS136938
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include 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 a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.

Eligibility Criteria

Inclusion

Inclusion Criteria for ALS participants:

  1. Age 18 years or older

  2. Capable of providing informed consent

  3. Willing to follow study procedures

  4. Diagnosis of ALS by a physician

  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)

Inclusion Criteria for control participants:

  1. Age 18 years or older

  2. Capable of providing informed consent

  3. Willing to follow study procedures

  4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)

  5. No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.

  • ** Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.
  1. 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 for all participants:

  1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.

  2. Clinically significant unstable medical condition (other than ALS) (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.

Study Design

Total Participants: 2000
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, Irvine

    Irvine, 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 20007
    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

  • 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

  • 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

    Colombus, Ohio 43221
    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

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.