Clinical Research in ALS Study

NCT00136500 | Recruiting

• 1 other identifier: 20101021
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Amyotrophic Lateral Sclerosis

Keywords

genetics; biomarkers; pre-symptomatic; natural history

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• At least 18 years of age.
• Member of at least one of the following categories:
• Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
• Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
• Healthy controls
• Able and willing to comply with relevant procedures.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• University of Miami: lead
• ALS Association: collaborator
• ALS Recovery Fund: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Related Links

• ALS Research Collaboration

Biospecimen

Retention: SAMPLES WITH DNA

DNA, blood, urine, CSF, skin biopsies

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Benatar, MD, PhD.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure Grignon, MD

CONTACT

888-413-9315; fals@med.miami.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: February 1, 2005
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)