Clinical Research in ALS Study (CRiALS)

Clinical Research in Amyotrophic Lateral Sclerosis

CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis

Detailed Description

Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Anne-Laure Grignon, MD; Phone Number: 888-413-9315; Email: fals@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Anne-Laure Grignon, MD; Phone Number: 888-413-9315; Email: fals@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The CRiALS research program aims to recruit three types of participants:

• Individuals affected with ALS or a related neurodegenerative disease
• Unaffected individuals from pedigrees in which the genetic cause of ALS is known
• Healthy controls

Description

Inclusion Criteria:

1. At least 18 years of age.

2. Member of at least one of the following categories:

   1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
   2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
   3. Healthy controls
3. Able and willing to comply with relevant procedures.

Exclusion Criteria:

1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Healthy controls
Individuals affected with ALS; This population be sporadic or familial ALS.
Unaffected individuals from families in which the genetic cause of ALS is known; This population includes pre-symptomatic individuals at genetic risk for ALS or a related neurodegenerative disorder (i.e., FTD).
Individuals affected with an ALS-related neurodegenerative disease; This would include FTD, MSP, IBMPFD, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Since this is an umbrella/gateway protocol through which individuals are recruited to participate in a range of studies, outcome is assessed in terms of recruitment.	Annually

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: ALS Association; ALS Recovery Fund
• Investigators: Principal Investigator: Michael Benatar, MD, PhD., University of Miami

Publications and helpful links

Helpful Links

• ALS Research Collaboration

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037

Study Registration Dates

• First Submitted: August 25, 2005
• First Submitted That Met QC Criteria: August 26, 2005
• First Posted (Estimated): August 29, 2005

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: genetics; biomarkers; natural history; pre-symptomatic
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 20101021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No