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The Pre-symptomatic Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study
NCT00317616 · University of Miami
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Healthy individuals from fALS families with a known genetic mutation will be included in this study. We encourage people who have previously undergone genetic testing and were found to carry the mutation that affects their family as well as those who do not know their genetic 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 eligible to complete study visits will travel to Miami (at our expense) approximately every 12-24 months for a period of 10 years or longer and will perform various biomarker procedures. Between visits, participants will complete phone calls about their health.
Eligibility criteria
Inclusion Criteria
* A member of a family in which a mutation in a gene associated with ALS has been identified.
* No symptoms to suggest the presence of ALS (i.e. study participants must currently be healthy).
* Having at least 50% probability of carrying an ALS associated gene mutation based on family pedigree.
* Willingness to undergo genetic testing, with the option of whether or not to learn the results.
* Willingness and availability to travel to Miami for a few days approximately every 12 to 24 months to complete biomarker procedures (e.g, MRI, blood draws, spinal tab/lumbar puncture, cognitive testing)
Exclusion Criteria
* Diagnosis of ALS
* Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions.
Study design
Enrollment target: 500 participants
Age groups: adult, older_adult
Timeline
Starts: 2006-04
Estimated completion: 2037-12
Last updated: 2026-03-20
Primary outcomes
- • Risk Factors for Progression to familial ALS (Years)
Sponsor
University of Miami · other
With: ALS Association
Contacts & investigators
ContactAnne-Laure M Grignon, MD · contact · fals@med.miami.edu · 1-888-413-9315
InvestigatorMichael G Benatar, MD, PhD. · principal_investigator, University of Miami
All locations (1)
University of MiamiRecruiting
Miami, Florida, United States