NCT00317616 The Pre-symptomatic Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study
| NCT ID | NCT00317616 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2006-04 |
| Primary Completion | 2037-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2006-04 with a primary completion date of 2037-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) people from familial ALS (fALS) pedigrees in which a known genetic mutation associated with ALS has been identified; for this study, a fALS pedigree is one with two biologically related individuals who have or have had ALS and/or FTD. Individuals who may be at genetic risk for ALS and who belong to families with at least one affected family member who has tested positive for a known ALS genetic mutation may also be eligible to participate. Our goal is to study the pre-symptomatic phase, onset and progression of ALS and to learn more about genetic and environmental factors that put people at risk for developing ALS.
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.
Contact & Investigator
Michael G Benatar, MD, PhD.
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT00317616 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00317616 currently recruiting?
Yes, NCT00317616 is actively recruiting participants. Contact the research team at fals@med.miami.edu for enrollment information.
Where is the NCT00317616 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT00317616 clinical trial?
NCT00317616 is sponsored by University of Miami. The principal investigator is Michael G Benatar, MD, PhD. at University of Miami. The trial plans to enroll 500 participants.
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