Actively Recruiting

Age: 18Years +
All Genders
NCT00317616

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

Led by University of Miami · Updated on 2026-03-20

500

Participants Needed

1

Research Sites

1652 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

A

ALS Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a member of a family with a known genetic mutation linked to ALS.
  • Be currently healthy with no symptoms suggesting ALS.
  • Have at least a 50% chance of carrying an ALS-related gene mutation based on family history.
  • Be willing to undergo genetic testing and decide whether or not to learn the results.
  • Be willing and able to travel to Miami approximately every 12 to 24 months for biomarker testing (e.g., MRI, blood draws, spinal tap, cognitive tests).
Not Eligible

You will not qualify if you...

  • Have a diagnosis of ALS.
  • Have any condition or situation that could interfere with biomarker data or participation, including neurological, psychological, or medical issues as determined by the study doctor.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

A

Anne-Laure M Grignon, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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