ASSESS ALL ALS Study

Purpose

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.

Condition

  • Amyotrophic Lateral Sclerosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 35294
Contact:
Melanie Benge
205-975-0445
melaniebenge@uabmc.edu

Barrow Neurological Institute
Phoenix, Arizona 85013
Contact:
Christopher Shiver
6024067773
fulton.research@dignityhealth.org

University of California, Irvine
Irvine, California 92868
Contact:
Rosa Gonzalez
714-456-6191
rosaig1@hs.uci.edu

University of California San Diego
La Jolla, California 98037
Contact:
Gil Gutierrez
858-246-2325
grg005@health.ucsd.edu

University of California, San Francisco
San Francisco, California 94143
Contact:
Hannah George
415-353-2959
hannah.george@ucsf.edu

University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
Alexis Shepardson
303-724-4644
neuroresearch@cuanschutz.edu

Hospital For Special Care
New Britain, Connecticut 06053
Contact:
Sabine Lebel-Hardenac
shardenack@hfsc.org

Georgetown University
Washington, District of Columbia 20007
Contact:
Arthur Zimmer
301-956-6489
az642@georgetown.edu

Mayo Clinic
Jacksonville, Florida 32224
Contact:
Jany Dagher
904-953-3730
dagher.jany@mayo.edu

Saint Alphonsus Regional Medical Center
Boise, Idaho 83704
Contact:
Helena Snider
208-367-7397
neuro.research@saintalphonsus.org

Northwestern University
Chicago, Illinois 60611
Contact:
Anirudh Muralidharan
312-503-6823
anirudh.muralidharan@northwestern.edu

Indiana University
Indianapolis, Indiana 46202
Contact:
Angela Micheels
317-963-7385
amicheel@iu.edu

John Hopkins University
Baltimore, Maryland 21205
Contact:
Delayne Willie
(410)502-6597
dwillie2@jh.edu

Nih/Ninds
Bethseda, Maryland 20892
Contact:
Katelyn Porter
301-451-1229
katelyn.porter@nih.gov

Massachusetts General Brigham
Boston, Massachusetts 02145
Contact:
Aisling Finnegan
(617) 726-1880
mghassessallals@mgb.org

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Caroline Piecuch
734-936-8781
carolinp@med.umich.edu

Henry Ford Health
Detroit, Michigan 48202
Contact:
Anne Vallis
313-916-1364
avallis1@hfhs.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Julia Munoz
612-624-9989
munoz156@umn.edu

Washington University
Saint Louis, Missouri 63110
Contact:
Jesse Markway
1-844-257-2273
als@wustl.edu

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Nicholas Miller
(402) 552-6241
nicholas.miller@unmc.edu

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Kathleen Sullivan
603-650-6496
neuroresearch@hitchcock.org

Columbia University
New York, New York 10032
Contact:
Ben Hoover
646-574-7399
bnh2119@cumc.columbia.edu

Duke University
Durham, North Carolina 27705
Contact:
Emma Ward
919-600-3626
emma.ward@duke.edu

Ohio State University
Colombus, Ohio 43221
Contact:
Carly Failor
614-293-4973
alsresearch@osumc.edu

Providence ALS Center
Portland, Oregon 97213
Contact:
Kimberly Perry
(971) 231-8245
kimberly.perry2@providence.org

Penn State Health
Hershey, Pennsylvania 17033
Contact:
Michele Hare
717-531-8257
nervemuscle@pennstatehealth.psu.edu

Temple University
Philadelphia, Pennsylvania 19140
Contact:
John Furey
267-694-0573
tuf40109@temple.edu

Texas Neurology
Dallas, Texas 75206
Contact:
Haley Rucker
214-827-3610
hrucker@texasneurology.com

University of Utah
Salt Lake City, Utah 84132
Contact:
Scott Redlin
801-581-7437
scott.redlin@utah.edu

Virginia Commonwealth University
Richmond, Virginia 23298
Contact:
Brianne Schibley-Laird
315-651-9378
brianna.schibleylaird@vcuhealth.org

University of Washington
Seattle, Washington 98195
Contact:
Kinsey Chapman
(206) 543-0081
kinseyc@uw.edu

CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico 00935
Contact:
Frances M Aponte
734-936-8781
frances.aponte2@upr.edu

More Details

NCT ID
NCT06578195
Status
Recruiting
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix

Study Contact

ALL ALS Patient Navigator
602-845-0248
info@all-als.org