Status:
RECRUITING
The Pre-symptomatic Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study
Lead Sponsor:
University of Miami
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
Pre-fALS is a prospective natural history and biomarker study of people not yet affected with ALS, but who are at genetic risk for developing ALS. The investigators aim to recruit unaffected (healthy)...
Detailed Description
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 mutat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00317616
Start Date
April 1 2006
End Date
December 1 2037
Last Update
February 26 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136