ASSESS ALL ALS Study

NCT06578195 | Recruiting

• 3 other identifiers: 2024P0011321OT2NS1369381OT2NS136939
• Study Type: observational
• Target: 2,000
• Locations: 2 countries
• Sites: 32

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; Amyotrophic Lateral Sclerosis; biomarker; observational

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (7)

• ALS Impairment Multidomain scale (AIMS)

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

• Social Determinants of Health

  Months 3 and 4 for all cohorts

• Environmental History

  Month 1 for all cohorts

• Cognitive assessment (ECAS)

  Baseline, 12 and 24 months for all cohorts

• Vital Capacity

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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Massachusetts General Hospital: collaborator
• Foundation for the National Institutes of Health: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (32)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

University of California, Irvine

Irvine, California, 92868, United States

RECRUITING

University of California San Diego

La Jolla, California, 98037, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Hospital For Special Care

New Britain, Connecticut, 06053, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83704, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

John Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Nih/Ninds

Bethseda, Maryland, 20892, United States

RECRUITING

Massachusetts General Brigham

Boston, Massachusetts, 02145, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Ohio State University

Colombus, Ohio, 43221, United States

RECRUITING

Providence ALS Center

Portland, Oregon, 97213, United States

RECRUITING

Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Texas Neurology

Dallas, Texas, 75206, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

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

San Juan, Puerto Rico, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

ALL ALS Patient Navigator

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 29, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): July 25, 2029
• Last Updated: January 12, 2026

Record last verified: 2025-09

Locations

PR (1); US (31)