PREVENT ALL ALS Study

January 9, 2026 updated by: St. Joseph's Hospital and Medical Center, Phoenix

PREVENT ALL ALS - Longitudinal Biomarker Study for Participants Who Are Genetically at Risk for Amyotrophic Lateral Sclerosis (ALS)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ALL ALS Patient Navigator
  • Phone Number: 602-845-0248
  • Email: info@all-als.org

Study Locations

  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00935
        • Recruiting
        • CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
        • Contact:
        • Principal Investigator:
          • Valerie Wojna Muniz, MD, FAAN
        • Principal Investigator:
          • Brenda Deliz Roldan, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Principal Investigator:
          • Nan Jiang, MD
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Principal Investigator:
          • Shafeeq Ladha, MD
        • Contact:
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • John Ravits, MD
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
        • Principal Investigator:
          • Namita Goyal, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Laura Rosow, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Laura Foster, MD
        • Contact:
    • Connecticut
      • New Britain, Connecticut, United States, 06053
        • Recruiting
        • Hospital for Special Care
        • Principal Investigator:
          • Kevin Felice, DO
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 200007
        • Recruiting
        • Georgetown University
        • Principal Investigator:
          • Shakti Nayar, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Saint Alphonsus Regional Medical Center
        • Principal Investigator:
          • Jackie Whitesell, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Senda Ajroud-Driss, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Cynthia Bodkin, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • John Hopkins University
        • Contact:
        • Principal Investigator:
          • Nicholas Maragakis, MD
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • Nih/Ninds
        • Principal Investigator:
          • Justin Kwan, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02145
        • Recruiting
        • Massachusetts General Brigham
        • Principal Investigator:
          • James Berry, MD, MPH
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Eva Feldman, MD, PhD
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Ximena Arcila-Londono, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • David Walk, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Timothy Miller, MD, PhD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Americo Fernandes, MD, FAAN
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Principal Investigator:
          • Mark Garret, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Neil Shneider, MD, PhD
    • North Carolina
      • Durham, North Carolina, United States, 27705
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Stephen Kolb, MD, PhD
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence ALS Center
        • Principal Investigator:
          • Nicholas Olney, MD
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Principal Investigator:
          • Terry Heiman-Patterson, MD
        • Contact:
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Mark Bromberg, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Kelly Gwathmey, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Michael Weiss, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Approximately 600 participants are planned for this study enrolled. They are aged 18 years or older, and are at risk of developing ALS.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS Symptoms Questionnaire
Time Frame: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline
Questions to identify development of symptoms related to ALS
Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Environmental History
Time Frame: Once at Month 1 from Baseline
Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Once at Month 1 from Baseline
Cognitive assessment (ECAS)
Time Frame: at Baseline, 12, 24 and 36 months from baseline
ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function
at Baseline, 12, 24 and 36 months from baseline
Cognitive assessment (CDR-FTLD)
Time Frame: at Baseline, 12, 24 and 36 months from baseline
CDR-FTLD is a global assessment scale that evaluates severity of impairment across multiple domains in patients with Frontotemporal dementia (FTLD) spectrum disorders.
at Baseline, 12, 24 and 36 months from baseline
Hand-Held Dynamometry (HHD)
Time Frame: at Baseline, 12, 24 and 36 months from baseline
HHD is used as a quantitative measure of muscle strength. This will involve testing of the bilateral deltoid, biceps, triceps, wrist extension, FDI, ADM, APB, hip extension, quadriceps, hamstring, TA and grip strength.
at Baseline, 12, 24 and 36 months from baseline
Digital Speech Assessment
Time Frame: at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months
Participants will be asked to record voice samples at home once a month using a digital application installed on their device.
at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months
Vital Capacity (VC)
Time Frame: at Baseline, 12, 24 and 36 months from baseline
It is the change in respiratory function over time as measured by Slow Vital Capacity (SVC).
at Baseline, 12, 24 and 36 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Collaborators

Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Foundation for the National Institutes of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 25, 2029

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P001131
  • 1OT2NS136938 (U.S. NIH Grant/Contract)
  • 1OT2NS136939 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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