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NCT06581861RecruitingAccepts Healthy Volunteers

PREVENT ALL ALS Study

St. Joseph's Hospital and Medical Center, Phoenix

Start Date

7/25/2024

Completion Date

7/25/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age 18 years or older 2. Capable of providing informed consent 3. Willing to follow study procedures 4. 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. 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) Exclusion Criteria: 1. 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. 2. 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 3. 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 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. Inclusion Criteria for Genetic Testing Results Sub-study 1. Age 18 years of age or older 2. Capable of providing informed consent 3. Willing to follow study procedures 4. Currently enrolled in the PREVENT ALS Study

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Conditions

Amyotrophic Lateral Sclerosis

Locations

University of Alabama Birmingham

Birmingham, Alabama 35294

United States

Barrow Neurological Institute

Phoenix, Arizona 85013

United States

University of California San Diego

La Jolla, California 92037

United States

University of California Irvine

Orange, California 92868

United States

University of California, San Francisco

San Francisco, California 94143

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Hospital for Special Care

New Britain, Connecticut 06053

United States

Georgetown University

Washington D.C., District of Columbia 200007

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Saint Alphonsus Regional Medical Center

Boise, Idaho 83704

United States

Northwestern University

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

John Hopkins University

Baltimore, Maryland 21205

United States

Nih/Ninds

Bethesda, Maryland 20892

United States

Massachusetts General Brigham

Boston, Massachusetts 02145

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health

Detroit, Michigan 48202

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Washington University

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Columbia University

New York, New York 10032

United States

Duke University

Durham, North Carolina 27705

United States

Ohio State University

Columbus, Ohio 43221

United States

Providence ALS Center

Portland, Oregon 97213

United States

Penn State Health

Hershey, Pennsylvania 17033

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

Texas Neurology

Dallas, Texas 75206

United States

University of Utah

Salt Lake City, Utah 84132

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

University of Washington

Seattle, Washington 98195

United States

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

San Juan, Puerto Rico 00935

Puerto Rico