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Research on individuals at risk for ALS

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

Observational St. Joseph's Hospital and Medical Center, Phoenix · NCT06581861

This study is looking to gather health information and samples from people who are at risk for ALS but don’t have symptoms yet, to help researchers learn more about the disease.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorSt. Joseph's Hospital and Medical Center, Phoenix Academic / other
Locations32 sites (Birmingham, Alabama and 31 other locations)
Trial IDNCT06581861 on ClinicalTrials.gov

What this trial studies

The PREVENT ALL ALS initiative aims to collect clinical data and biological samples from individuals who are asymptomatic but genetically at risk for Amyotrophic Lateral Sclerosis (ALS). Participants will be monitored over a period of up to 36 months, with annual in-person visits and additional remote assessments. This observational study is part of a larger consortium funded by the NIH, which seeks to harmonize data for future ALS research. The collected information will be made available to the broader research community to advance understanding of ALS and related neurological disorders.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 or older who have a family history of ALS or frontotemporal dementia (FTD) and are asymptomatic.

Not a fit: Patients who are already exhibiting neurological signs or symptoms of ALS or FTD will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance early detection and understanding of ALS, potentially leading to improved prevention strategies.

How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding genetic risks associated with ALS.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Amyotrophic Lateral SclerosisALSBiomarkerObservationalat-risk
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.