PREVENT ALL ALS Study

NCT06581861 | Recruiting

• 3 other identifiers: 2024P0011311OT2NS1369381OT2NS136939
• Study Type: observational
• Target: 600
• 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 begin 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. PREVENT protocol is specific for asymptomatic participants who are genetically at risk for ALS. The participants will be followed for up to 36 months (3 years), and will include 4 in-person on-site visits once a year and 6 off-site(remote) visits once in 4 months. The study includes 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 in 4 months. Participants may also provide optional Cerebrospinal Fluid (CSF) samples.The participants may also opt into a sub-study if they are interested in genetic testing for ALS causative genes. The sub-study will involve a minimum of 3 visits over a course of 2-3 months. This will include a screening/pre-test genetic counseling visit, a return of genetic results and a post-test counseling visit.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; Amyotrophic Lateral Sclerosis; Biomarker; Observational; at-risk

Outcome Measures

Primary Outcomes (1)

• ALS Symptoms Questionnaire

  Questions to identify development of symptoms related to ALS

  Baseline, 4, 8, 12,16,20, 24, 28, 32 and 36 months form baseline

Secondary Outcomes (6)

• Environmental History

  Once at Month 1 from Baseline

• Cognitive assessment (ECAS)

  at Baseline, 12, 24 and 36 months from baseline

• Cognitive assessment (CDR-FTLD)

  at Baseline, 12, 24 and 36 months from baseline

• Hand-Held Dynamometry (HHD)

  at Baseline, 12, 24 and 36 months from baseline

• Digital Speech Assessment

  at Baseline, and at months 4,8,12,16,20,24,28,32 and 36 months

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

Approximately 600 participants are planned for this study enrolled. They are aged 18 years or older, and are at risk of developing ALS.

You may qualify if:

• Age 18 years or older
• Capable of providing informed consent
• Willing to follow study procedures
• First-degree relative of a known carrier of any ALS causative gene1 (regardless of whether ALS or FTD has actually been symptomatic in the family) OR First-degree relative of an individual with ALS and/or FTD in a family with a "compelling family history" of ALS/FTD, regardless of whether genetic testing has occurred in symptomatic family members. A "compelling family history" is defined as a pedigree with at least 2 close relatives who had ALS or FTD, with at least one of those family members having had ALS.
• 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:

• Evidence of neurological signs or symptoms concerning for ALS of FTD, at the discretion of the site investigator which will be communicated to the applicant along with referral for appropriate clinical follow-up.
• Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \<= 90 days (about 3 months) of screening, which in the opinion of the Investigator would interfere with the study procedures
• Clinically significant, unstable medical condition (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.
• Age 18 years of age or older
• Capable of providing informed consent
• Willing to follow study procedures
• Currently enrolled in the PREVENT ALS Study

Sponsors & Collaborators

• Massachusetts General Hospital: collaborator
• Foundation for the National Institutes of Health: collaborator
• St. Joseph's Hospital and Medical Center, Phoenix: lead
• 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 San Diego

La Jolla, California, 92037, United States

RECRUITING

University of California Irvine

Orange, California, 92868, 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, 200007, 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

Bethesda, 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

Columbus, 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 21, 2024
• First Posted: September 3, 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: 2025-01

Locations

US (31); PR (1)