Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2024-07-25
2029-07-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic ALS on-site participants
Symptomatic ALS Participants who are completing on-site visits at one of the 35 participating ALL ALS sites.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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)
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
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.
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.
18 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Foundation for the National Institutes of Health
OTHER
St. Joseph's Hospital and Medical Center, Phoenix
OTHER
Responsible Party
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Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California San Diego
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Hospital For Special Care
New Britain, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
John Hopkins University
Baltimore, Maryland, United States
Nih/Ninds
Bethseda, Maryland, United States
Massachusetts General Brigham
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Colombus, Ohio, United States
Providence ALS Center
Portland, Oregon, United States
Penn State Health
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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