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NCT06578195Recruiting

ASSESS ALL ALS Study

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2000 (estimated)
First submitted
20 Aug 2024
Start date
25 Jul 2024
Primary completion date
31 Jan 2029
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
NCT number
NCT06578195

What you commit to

  • Study type: Observational
  • Planned participants: 2000
  • From 25 Jul 2024 to the primary completion date, 31 Jan 2029
  • 37 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.

Other illness

  • 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.
  • 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.
  • 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.
  • Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.

Other

  • Current pregnancy based on participant self-report
  • Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.

Who the study is looking for

  • Age 18 years or older
  • Capable of providing informed consent
  • Willing to follow study procedures
  • Diagnosis of ALS by a physician
  • 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 or older
  • Capable of providing informed consent
  • Willing to follow study procedures
  • No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)
  • 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.
  • 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 in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
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San JuanPuerto RicoRecruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesRecruiting
John Hopkins University
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BaltimoreUnited StatesRecruiting
Nih/Ninds
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BethsedaUnited StatesRecruiting
University of Alabama Birmingham
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BirminghamUnited StatesRecruiting
Saint Alphonsus Regional Medical Center
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BoiseUnited StatesRecruiting
Massachusetts General Brigham
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BostonUnited StatesRecruiting
Synapticure (Remote Participation Only)
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ChicagoUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Ohio State University
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ColombusUnited StatesRecruiting
Texas Neurology
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DallasUnited StatesRecruiting
Nova Southeastern University
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DavieUnited StatesRecruiting
Henry Ford Health
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DetroitUnited StatesRecruiting
Duke University
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DurhamUnited StatesRecruiting
Penn State Health
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HersheyUnited StatesRecruiting
Indiana University
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IndianapolisUnited StatesRecruiting
University of California, Irvine
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IrvineUnited StatesRecruiting
Mayo Clinic
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JacksonvilleUnited StatesRecruiting
University of California San Diego
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La JollaUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesRecruiting
University of California, Los Angeles
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Los AngelesUnited StatesRecruiting
University of Minnesota
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MinneapolisUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Hospital for Special Care
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New BritainUnited StatesRecruiting
Columbia University
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New YorkUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
Temple University
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PhiladelphiaUnited StatesRecruiting
Barrow Neurological Institute
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PhoenixUnited StatesRecruiting
Providence ALS Center
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PortlandUnited StatesRecruiting
Virginia Commonwealth University
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RichmondUnited StatesRecruiting
University of Utah
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Salt Lake CityUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
University of Washington
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SeattleUnited StatesRecruiting
Washington University
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St LouisUnited StatesRecruiting
Georgetown University
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.