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ASSESS ALL ALS Study

NCT06578195 · St. Joseph's Hospital and Medical Center, Phoenix
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Official title
ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants
About this study
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.
Eligibility criteria
Inclusion Criteria for ALS participants: 1. Age 18 years or older 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) Inclusion Criteria for control participants: 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 for all participants: 1. 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. 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. 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.
Study design
Enrollment target: 2000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-07-25
Estimated completion: 2029-07-25
Last updated: 2026-01-12
Primary outcomes
  • ALS Functional Rating Scale-Revised (ALSFRS-R) (Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.)
  • ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE) (Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only)
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix · other
With: Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), Foundation for the National Institutes of Health
Contacts & investigators
ContactALL ALS Patient Navigator · contact · info@all-als.org · 602-845-0248
All locations (32)
University of Alabama BirminghamRecruiting
Birmingham, Alabama, United States
Barrow Neurological InstituteRecruiting
Phoenix, Arizona, United States
University of California, IrvineRecruiting
Irvine, California, United States
University of California San DiegoRecruiting
La Jolla, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Hospital For Special CareRecruiting
New Britain, Connecticut, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Saint Alphonsus Regional Medical CenterRecruiting
Boise, Idaho, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
John Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Nih/NindsRecruiting
Bethseda, Maryland, United States
Massachusetts General BrighamRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Columbia UniversityRecruiting
New York, New York, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Ohio State UniversityRecruiting
Colombus, Ohio, United States
Providence ALS CenterRecruiting
Portland, Oregon, United States
Penn State HealthRecruiting
Hershey, Pennsylvania, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
Texas NeurologyRecruiting
Dallas, Texas, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
University of WashingtonRecruiting
Seattle, Washington, United States
CHALS-CCT, University of Puerto Rico, Medical Sciences CampusRecruiting
San Juan, Puerto Rico, Puerto Rico
ASSESS ALL ALS Study · TrialPath