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Amyotrophic Lateral SclerosisNCT06578195

ASSESS ALL ALS Study

An observational study of Amyotrophic Lateral Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 37 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
2,000 participants
Where
37 sitesin 2 countries
Study dates
25 Jul 2024to 25 Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 12Show fewer
  • 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)

Who cannot join

  • 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.
  • Exclusion Criteria for participants undergoing optional Lumbar Puncture
  • 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.
  • Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.
Show all 9Show fewer
  • Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.
  • Current pregnancy based on participant self-report
  • Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.

Trial locations and contacts

37 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

ALL ALS Patient Navigator contact

602-845-0248

info@all-als.org

37 sites in 2 countries

United States36 sites, 36 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Caroline Piecuch, 734-936-8781, carolinp@med.umich.edu

    Eva Feldman, MD, PhD

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Alexis Shepardson, 303-724-4644, neuroresearch@cuanschutz.edu

    Laura Foster, MD

    Recruiting

  • John Hopkins University

    Baltimore, Maryland, 21205

    Colleen Kane, 410-502-6184, Ckane13@jh.edu

    Nicholas Maragakis, MD

    Recruiting

  • Nih/Ninds

    Bethseda, Maryland, 20892

    Katelyn Porter, 301-451-1229, katelyn.porter@nih.gov

    Justin Kwan, MD

    Recruiting

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

    Melanie Benge, 205-975-0445, melaniebenge@uabmc.edu

    Nan Jiang, MD

    Recruiting

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83704

    Helena Snider, 208-367-7397, neuro.research@saintalphonsus.org

    Jackie Whitesell, MD

    Recruiting

  • Massachusetts General Brigham

    Boston, Massachusetts, 02145

    Miranda Duncan, (617) 643-9550, mghassessallals@mgb.org

    James Berry, MD, MPH

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Aeryn Hopwood, (312) 503-5166, aeryn.hopwood@northwestern.edu

    Senda Ajroud-Driss, MD

    Recruiting

  • Synapticure (Remote Participation Only)

    Chicago, Illinois, 60612

    Lindsey Haddock, (708) 507-9691, lindsey@synapticure.com

    Anuj Dhir, MD

    Recruiting

  • Ohio State University

    Colombus, Ohio, 43221

    Alexander Michael, 614-685-4741, alsresearch@osumc.edu

    Stephen Kolb, MD, PhD

    Recruiting

  • Texas Neurology

    Dallas, Texas, 75206

    Haley Rucker, 214-827-3610, hrucker@texasneurology.com

    Reham Azab, razab@texasneurology.com

    Recruiting

  • Nova Southeastern University

    Davie, Florida, 33314

    Donovan Mott, 954-262-6387, donovan.mott@nova.edu

    Eduardo Locatelli, MD

    Recruiting

  • Henry Ford Health

    Detroit, Michigan, 48202

    Maria Stotland, 313-916-3359, mstotla1@hfhs.org

    Ximena Arcila-Londono, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27705

    Duke Research Team, alsresearch@dm.duke.edu

    Xiaoyan Li, MD, PhD

    Recruiting

  • Penn State Health

    Hershey, Pennsylvania, 17033

    Michele Hare, 717-531-8257, nervemuscle@pennstatehealth.psu.edu

    Zachary Simmons, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Lisa Grinstead, 317-963-7382, lgrinste@iu.edu

    Patti Hogan, 617-724-9196, hoganpr@iu.edu

    Recruiting

  • University of California, Irvine

    Irvine, California, 92868

    Rosa Gonzalez, 714-456-6191, rosaig1@hs.uci.edu

    Namita Goyal, MD

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Jany Dagher, 904-953-3730, dagher.jany@mayo.edu

    Jeffery Gainer, gainer.jeffery@mayo.edu

    Recruiting

  • University of California San Diego

    La Jolla, California, 98037

    Gil Gutierrez, 858-246-2325, grg005@health.ucsd.edu

    John Ravits, MD

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Gina Kersey, 603-650-6496, DHALLALS@Hitchcock.org

    Mark Garret, MD

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Elizabeth Cruz, 310-825-6930, elizabethcruz@mednet.ucla.edu

    Yigit Karasozen, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Julia Munoz, 612-624-9989, munoz156@umn.edu

    David Walk, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Nicola Rutherford, 615-875-9137, nicola.j.rutherford.1@vumc.org

    Amanda Peltier, MD

    Recruiting

  • Hospital For Special Care

    New Britain, Connecticut, 06053

    Sabine Lebel-Hardenac, shardenack@hfsc.org

    Kevin Felice, DO

    Recruiting

  • Columbia University

    New York, New York, 10032

    Ben Hoover, 212-305-6788, alsresearch@cumc.columbia.edu

    Neil Shneider, MD, PhD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Veronica Alonso, 402-559-2012, valonso@unmc.edu

    Nathan McKain, (402) 552-6241, nmckain@unmc.edu

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Matthew Burst, 215-615-0550, matthew.burst@pennmedicine.upenn.edu

    Colin Quinn, MD

    Recruiting

  • Temple University

    Philadelphia, Pennsylvania, 19140

    John Furey, 267-694-0573, tuf40109@temple.edu

    Terry Heiman-Patterson, MD

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

    Christopher Shiver, 6024067773, fulton.research@dignityhealth.org

    Shafeeq Ladha, MD

    Recruiting

  • Providence ALS Center

    Portland, Oregon, 97213

    Kimberly Perry, (971) 231-8245, kimberly.perry2@providence.org

    Nicholas Olney, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Demetrius Carter, 804-655-0691, demetrius.r.carter@vcuhealth.org

    Kelly Gwathmey, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Scott Redlin, 801-581-7437, scott.redlin@utah.edu

    Mark Bromberg, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Hannah George, 415-353-2959, hannah.george@ucsf.edu

    Laura Roscow, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Lila Brisk, (206) 543-0454, lbrisk@uw.edu

    Michael Weiss, MD

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Jesse Markway, 1-844-257-2273, als@wustl.edu

    Timothy Miller, MD, PhD

    Recruiting

  • Georgetown University

    Washington D.C., District of Columbia, 20007

    Cassandra Holmes, 904-953-3730, cassie.holmes@georgetown.edu

    Shakti Nayar, MD

    Recruiting

Other trials in United States

Puerto Rico1 site, 1 recruiting

  • CHALS-CCT, University of Puerto Rico, Medical Sciences Campus

    San Juan, Puerto Rico, 00935

    Frances M Aponte, 734-936-8781, frances.aponte2@upr.edu

    Valerie Wojna Muniz, MD, FAAN

    Recruiting

Other trials in Puerto Rico

About this study

Official title: 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.

Keywords
ALS, Amyotrophic Lateral Sclerosis, biomarker, observational
Medical subject headings
Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06578195
Study groupRoleWhat they receive
Symptomatic ALS on-site participantsSymptomatic ALS Participants who are completing on-site visits at one of the 35 participating ALL ALS sites.
Symptomatic ALS off-site (remote) participantsSymptomatic ALS Participants who are completing visits study visits remotely through video-conferencing. Home Phlebotomy is being used to collect blood from these participants.
Control participantsControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. ALS Functional Rating Scale-Revised (ALSFRS-R)

    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.

    Measured: Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.

  2. ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE)

    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.

    Measured: Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only

Secondary outcomes (7)

  1. ALS Impairment Multidomain scale (AIMS)

    Questionnaires completed by participants that assess severity of the ALS disease

    Measured: 1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only

  2. Social Determinants of Health

    Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes

    Measured: Months 3 and 4 for all cohorts

  3. Environmental History

    Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc.

    Measured: Month 1 for all cohorts

  4. Cognitive assessment (ECAS)

    ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function

    Measured: Baseline, 12 and 24 months for all cohorts

  5. Vital Capacity

    Change in respiratory function over time as measured by Slow Vital Capacity (SVC).

    Measured: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants

  6. Digital Speech Assessment

    Participants will be asked to record voice samples at home once a month using a digital application installed on their device.

    Measured: Baseline, and monthly (at month 1,2, 3 through month 24 from baseline)

  7. HHD of 3 hand muscles bilaterally

    Hand-held dynamometry (HHD) will be used as a quantitative measure of muscle strength for the three intrinsic hand muscles, bilaterally

    Measured: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start25 Jul 2024
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion25 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578195
Sponsor's protocol ID
2024P001132
Other IDs
1OT2NS136938, 1OT2NS136939
Status last verified
Sep 2025
First submitted
20 Aug 2024
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by St. Joseph's Hospital and Medical Center, Phoenix at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ALL ALS Patient Navigator (602-845-0248, info@all-als.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ALS Functional Rating Scale-Revised (ALSFRS-R) (time frame: Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06578195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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ASSESS ALL ALS Study (NCT06578195) | AzTrials