Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06578195

ASSESS ALL ALS Study

Led by St. Joseph's Hospital and Medical Center, Phoenix · Updated on 2026-01-12

2000

Participants Needed

32

Research Sites

260 weeks

Total Duration

On this page

Sponsors

S

St. Joseph's Hospital and Medical Center, Phoenix

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ASSESS ALL ALS Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Capable of providing informed consent
  • Willing to follow study procedures
  • Diagnosis of ALS by a physician (for ALS participants)
  • No diagnosis of ALS, Progressive Muscular Atrophy (PMA), or Primary Lateral Sclerosis (PLS) (for control participants)
  • No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member unless previously tested negative for known ALS genes (for control participants)
  • Access to a smartphone, computer, or tablet with internet access (home or public access)
Not Eligible

You will not qualify if you...

  • Significant cognitive impairment, clinical dementia, or unstable psychiatric illness that would interfere with study procedures
  • Clinically significant unstable medical condition other than ALS making 12 months follow-up unlikely
  • Medically unable to undergo lumbar puncture (for those opting for lumbar puncture)
  • Allergy to local anesthetics such as Lidocaine (for lumbar puncture)
  • Use of anticoagulant or antiplatelet medications that cannot be safely stopped before lumbar puncture
  • Blood disorders or dialysis treatment for renal failure (for lumbar puncture)
  • Current pregnancy (for lumbar puncture)
  • Investigator judgment deeming participant unable to undergo multiple lumbar punctures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

University of Alabama Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

Actively Recruiting

3

University of California, Irvine

Irvine, California, United States, 92868

Actively Recruiting

4

University of California San Diego

La Jolla, California, United States, 98037

Actively Recruiting

5

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

6

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

7

Hospital For Special Care

New Britain, Connecticut, United States, 06053

Actively Recruiting

8

Georgetown University

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

9

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

10

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States, 83704

Actively Recruiting

11

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

12

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

John Hopkins University

Baltimore, Maryland, United States, 21205

Actively Recruiting

14

Nih/Ninds

Bethseda, Maryland, United States, 20892

Actively Recruiting

15

Massachusetts General Brigham

Boston, Massachusetts, United States, 02145

Actively Recruiting

16

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

17

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

18

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

19

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

20

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

21

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

22

Columbia University

New York, New York, United States, 10032

Actively Recruiting

23

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

24

Ohio State University

Colombus, Ohio, United States, 43221

Actively Recruiting

25

Providence ALS Center

Portland, Oregon, United States, 97213

Actively Recruiting

26

Penn State Health

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

27

Temple University

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

28

Texas Neurology

Dallas, Texas, United States, 75206

Actively Recruiting

29

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

30

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

31

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

32

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

San Juan, Puerto Rico, Puerto Rico, 00935

Actively Recruiting

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Research Team

A

ALL ALS Patient Navigator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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