Collecting data and samples from ALS patients and controls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama Birmingham
  Birmingham, Alabama, United States Recruiting
• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• University of California, Irvine
  Irvine, California, United States Recruiting
• University of California San Diego
  La Jolla, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.