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RECRUITING

ASSESS ALL ALS Study

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

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

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. This consortium is being 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. ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include 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 a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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)
•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.
+2 more criteria

Exclusion Criteria

•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.
•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.

Locations (32)

University of Alabama Birmingham

Birmingham, Alabama, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

University of California, Irvine

Irvine, California, United States

University of California San Diego

La Jolla, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Hospital For Special Care

New Britain, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Mayo Clinic

Jacksonville, Florida, United States

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Key Dates

Start Date

July 25, 2024

Primary Completion Date

January 31, 2029

Completion Date

July 25, 2029

Last Updated

January 12, 2026

Enrollment

2,000

ESTIMATED participants

Conditions

Amyotrophic Lateral Sclerosis

Contacts

ALL ALS Patient Navigator

CONTACT

602-845-0248 info@all-als.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ASSESS ALL ALS Study

Inclusion Criteria

Exclusion Criteria

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