ASSESS ALL ALS Study

June 15, 2026 updated by: St. Joseph's Hospital and Medical Center, Phoenix

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 00935
        • Recruiting
        • CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
        • Contact:
        • Principal Investigator:
          • Valerie Wojna Muniz, MD, FAAN
        • Principal Investigator:
          • Brenda Deliz Roldan, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Principal Investigator:
          • Nan Jiang, MD
        • Contact:
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Institute
        • Principal Investigator:
          • Shafeeq Ladha, MD
        • Contact:
    • California
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Namita Goyal, MD
        • Contact:
      • La Jolla, California, United States, 98037
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • John Ravits, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Laura Roscow, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Principal Investigator:
          • Laura Foster, MD
        • Contact:
    • Connecticut
      • New Britain, Connecticut, United States, 06053
        • Recruiting
        • Hospital For Special Care
        • Principal Investigator:
          • Kevin Felice, DO
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University
        • Principal Investigator:
          • Shakti Nayar, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Saint Alphonsus Regional Medical Center
        • Principal Investigator:
          • Jackie Whitesell, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Senda Ajroud-Driss, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Cynthia Bodkin, MD
        • Contact:
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • John Hopkins University
        • Contact:
        • Principal Investigator:
          • Nicholas Maragakis, MD
      • Bethseda, Maryland, United States, 20892
        • Recruiting
        • Nih/Ninds
        • Principal Investigator:
          • Justin Kwan, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02145
        • Recruiting
        • Massachusetts General Brigham
        • Contact:
        • Principal Investigator:
          • James Berry, MD, MPH
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Eva Feldman, MD, PhD
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Ximena Arcila-Londono, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • David Walk, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Timothy Miller, MD, PhD
        • Contact:
          • Jesse Markway
          • Phone Number: 1-844-257-2273
          • Email: als@wustl.edu
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph Americo Fernandes, MD, FAAN
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Principal Investigator:
          • Mark Garret, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Neil Shneider, MD, PhD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Xiaoyan Li, MD, PhD
        • Contact:
    • Ohio
      • Colombus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Stephen Kolb, MD, PhD
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence ALS Center
        • Principal Investigator:
          • Nicholas Olney, MD
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University
        • Principal Investigator:
          • Terry Heiman-Patterson, MD
        • Contact:
    • Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Mark Bromberg, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Kelly Gwathmey, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Michael Weiss, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

An initial cohort of approximately 2000 to 3000 participants will be recruited for this study. This includes at least 1600 symptomatic ALS participants (Cohort 1) and at least 450 control participants (Cohort 2). Though the exact percentages of in-clinic and remote participants are unknown at this time, it is anticipated that approximately 600 of the symptomatic ALS participants and 450 of the control participants will be recruited from the site clinic or local ALS community and will be coming to the sites for study visits. These numbers may differ substantially from the final enrollment numbers based on preference of participants enrolling in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Symptomatic ALS on-site participants
Symptomatic ALS Participants who are completing on-site visits at one of the 35 participating ALL ALS sites.
Symptomatic ALS off-site (remote) participants
Symptomatic ALS Participants who are completing visits study visits remotely through video-conferencing. Home Phlebotomy is being used to collect blood from these participants.
Control participants
Control participants who do not have a diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS). These participants complete on-site visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS Functional Rating Scale-Revised (ALSFRS-R)
Time Frame: Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.
Questionnaire administered by a clinician that includes a series of questions about participants' ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.
ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE)
Time Frame: Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only
Questionnaires completed by participants that includes questions about participants ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS Impairment Multidomain scale (AIMS)
Time Frame: 1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only
Questionnaires completed by participants that assess severity of the ALS disease
1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only
Social Determinants of Health
Time Frame: Months 3 and 4 for all cohorts
Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Months 3 and 4 for all cohorts
Environmental History
Time Frame: Month 1 for all cohorts
Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc.
Month 1 for all cohorts
Cognitive assessment (ECAS)
Time Frame: Baseline, 12 and 24 months for all cohorts
ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function
Baseline, 12 and 24 months for all cohorts
Vital Capacity
Time Frame: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants
Digital Speech Assessment
Time Frame: Baseline, and monthly (at month 1,2, 3 through month 24 from baseline)
Participants will be asked to record voice samples at home once a month using a digital application installed on their device.
Baseline, and monthly (at month 1,2, 3 through month 24 from baseline)
HHD of 3 hand muscles bilaterally
Time Frame: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants
Hand-held dynamometry (HHD) will be used as a quantitative measure of muscle strength for the three intrinsic hand muscles, bilaterally
Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Collaborators

Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Foundation for the National Institutes of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 25, 2029

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P001132
  • 1OT2NS136938 (U.S. NIH Grant/Contract)
  • 1OT2NS136939 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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