The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

This study is currently recruiting participants.

Verified by Emory University, February 2009

First Received: April 24, 2006 Last Updated: February 16, 2009 History of Changes

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00317616

Purpose

We aim to recruit unaffected (healthy) people from SOD1 positive families in which at least two relatives have been affected with ALS. Our goal is to identify factors, both genetic and environmental, which put people at risk for developing ALS in the future.

Condition
Amyotrophic Lateral Sclerosis

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study

Further study details as provided by Emory University:

Primary Outcome Measures:

Risk Factors for Progression to familial ALS [ Time Frame: Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	April 2006

Detailed Description:

Healthy people from SOD1 positive familial ALS families will be included in this study. We encourage people who know that they are SOD1 positive as well as those who do not know their SOD1 status to contact us. Those who wish to participate and to learn the results of genetic testing, may do so after undergoing genetic counseling. It is also possible to participate without learning the results of genetic testing. Participants in the study will travel to Emory (at our expense) on an annual basis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Healthy individuals who harbor a mutation in the SOD1 gene.

Criteria

A member of a family in which at least two relatives have been or currently are affected with ALS.
The presence of a genetic change (mutation) in the SOD1 gene in a family member.
No symptoms to suggest the presence of ALS (i.e. study participants must currently be healthy).
Willingness to undergo genetic testing, with the option of whether or not to learn the results.
Willingness to travel to Emory annually for in-person study evaluations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317616

Contacts

Contact: Sue Gronka, RN

888-413-9315

fALS@emory.edu

Locations

United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Michael Benatar, MD, PhD.

Emory University

More Information

No publications provided

Responsible Party:	Emory University ( Michael Benatar )
Study ID Numbers:	1369-2005
Study First Received:	April 24, 2006
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00317616 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

FALS, SOD1, familial, genetic testing, genetic counseling, Emory, ALS

Study placed in the following topic categories:

Lou Gehrig's Disease
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases

Sclerosis
Neurodegenerative Diseases
Degenerative Motor System Disease
Motor Neuron Disease

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on May 07, 2009