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Amyotrophic Lateral SclerosisNCT06581861

PREVENT ALL ALS Study

An observational study of Amyotrophic Lateral Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 32 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
600 participants
Where
32 sitesin 2 countries
Study dates
25 Jul 2024to 25 Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.
  • 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
  • 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
  • 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).
  • Allergy to Lidocaine or other local anesthetic agents.
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  • Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
  • Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
  • Current pregnancy based on participant self-report
  • Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

United States31 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • John Hopkins University

    Baltimore, Maryland, 21205

  • Nih/Ninds

    Bethesda, Maryland, 20892

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83704

  • Massachusetts General Brigham

    Boston, Massachusetts, 02145

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio State University

    Columbus, Ohio, 43221

  • Texas Neurology

    Dallas, Texas, 75206

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27705

  • Penn State Health

    Hershey, Pennsylvania, 17033

  • Indiana University

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of California San Diego

    La Jolla, California, 92037

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Hospital for Special Care

    New Britain, Connecticut, 06053

  • Columbia University

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California Irvine

    Orange, California, 92868

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Providence ALS Center

    Portland, Oregon, 97213

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California, San Francisco

    San Francisco, California, 94143

  • University of Washington

    Seattle, Washington, 98195

  • Washington University

    St Louis, Missouri, 63110

  • Georgetown University

    Washington D.C., District of Columbia, 200007

Other trials in United States

Puerto Rico1 site

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

    San Juan, Puerto Rico, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Keywords
ALS, Amyotrophic Lateral Sclerosis, Biomarker, Observational, at-risk
Medical subject headings
Amyotrophic Lateral Sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ALS Symptoms Questionnaire

    Questions to identify development of symptoms related to ALS

    Measured: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline

Secondary outcomes (6)

  1. Environmental History

    Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes

    Measured: Once at Month 1 from Baseline

  2. Cognitive assessment (ECAS)

    ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function

    Measured: at Baseline, 12, 24 and 36 months from baseline

  3. Cognitive assessment (CDR-FTLD)

    CDR-FTLD is a global assessment scale that evaluates severity of impairment across multiple domains in patients with Frontotemporal dementia (FTLD) spectrum disorders.

    Measured: at Baseline, 12, 24 and 36 months from baseline

  4. Hand-Held Dynamometry (HHD)

    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.

    Measured: at Baseline, 12, 24 and 36 months from baseline

  5. Digital Speech Assessment

    Participants will be asked to record voice samples at home once a month using a digital application installed on their device.

    Measured: at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months

  6. Vital Capacity (VC)

    It is the change in respiratory function over time as measured by Slow Vital Capacity (SVC).

    Measured: at Baseline, 12, 24 and 36 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start25 Jul 2024
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion25 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06581861
Sponsor's protocol ID
2024P001131
Other IDs
1OT2NS136938, 1OT2NS136939
Status last verified
Oct 2026
First submitted
21 Aug 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ALS Symptoms Questionnaire (time frame: Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06581861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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