Clinical Research in ALS Study (CRiALS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease
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 Design

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Study Type :	Observational
Estimated Enrollment :	10000 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Clinical Research in Amyotrophic Lateral Sclerosis
Study Start Date :	February 2005
Estimated Primary Completion Date :	December 2027
Estimated Study Completion Date :	December 2027

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Recruitment [ Time Frame: Annually ]
   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.

Biospecimen Retention:   Samples With DNA

DNA, blood, urine, CSF, skin biopsies

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Criteria

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:

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).

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Eliana Reyes	888-413-9315	fals@med.miami.edu
Contact: Danielle Dauphin	888-413-9315	fals@med.miami.edu

Locations

United States, Florida
University of Miami	Recruiting
Miami, Florida, United States, 33136
Contact: Eliana Reyes 888-413-9315 fals@med.miami.edu

Sponsors and Collaborators

Michael Benatar

ALS Association

ALS Recovery Fund

Investigators

Principal Investigator:	Michael Benatar, MD, PhD.	University of Miami

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

ALS Research Collaboration 

Responsible Party:	Michael Benatar, MBChB, MS, DPhil, University of Miami
ClinicalTrials.gov Identifier:	NCT00136500 History of Changes
Other Study ID Numbers:	FALS feasibility
First Posted:	August 29, 2005
Last Update Posted:	March 16, 2018
Last Verified:	March 2018

Keywords provided by Michael Benatar, University of Miami:

genetics; biomarkers; pre-symptomatic; natural history

Additional relevant MeSH terms:

Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases	Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases