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Collecting data and samples from ALS patients and controls

ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants

Observational St. Joseph's Hospital and Medical Center, Phoenix · NCT06578195

This study is collecting health information and samples from people with ALS, those who carry ALS-related genes, and healthy individuals to help future research on ALS and similar conditions.

Quick facts

Study typeObservational
Enrollment2000 (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 IDNCT06578195 on ClinicalTrials.gov

What this trial studies

The ASSESS ALL ALS initiative aims to gather a comprehensive range of clinical information and biological samples from individuals diagnosed with Amyotrophic Lateral Sclerosis (ALS), ALS gene carriers, and control participants. This observational study is funded by the NIH and managed by clinical coordinating centers at Barrow Neurological Institute and Massachusetts General Hospital, with multiple sites across the country. Participants will be followed for two years, and the collected data will be harmonized and made available for future research into ALS and related neurological disorders.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of ALS or those without ALS who meet specific control criteria.

Not a fit: Patients with conditions such as Progressive Muscular Atrophy or Primary Lateral Sclerosis, or those with a familial history of ALS without prior negative genetic testing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of ALS and lead to improved diagnostic and therapeutic strategies.

How similar studies have performed: Other studies focusing on ALS biomarkers and observational data collection have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
6. 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.

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 SclerosisALSbiomarkerobservational
Last reviewed 2026-06-09 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.