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ALS Families Project: Understanding Familial ALS

This observational study, called the ALS Families Project, is looking for people aged 18 to 105 who do not have symptoms of ALS (Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's Disease) or fronto-temporal dementia. You can join if you've already had genetic testing showing an ALS-related gene mutation, or if a close family member carries such a mutation. The study aims to understand why motor neuron degeneration begins and how it progresses in people with a family history of ALS. It will follow participants annually for up to 10 years to gather information that could help develop new ways to prevent and treat ALS. Genetic counseling and testing are provided to help you understand your genetic status and risk.

Study design
This is an observational study planning to enroll 300 participants. It is designed to watch and learn from people over time without giving any specific intervention.
What's involved
If you join, you will have research visits every 6-12 months. The study will follow you for up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to observe the time it takes for symptoms related to gene mutations to appear.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03865420

Amyotrophic Lateral Sclerosis (ALS) Families Project

Recruiting
Not specifiedAges 18+Observational
Columbia University
~300 participants
Updated 2026-01-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to emergence of symptoms attributable to gene mutations
Measured over Up to 10 years

Conditions

ALS

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NCT03865420

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Matthew Harms, MD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Elizabeth Harrington, MS, CGC
[email protected]
347-852-5315
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Men or women of any race or ethnicity aged 18 or older
No symptoms of ALS or fronto-temporal dementia at enrollment
Scenario 1: has already had genetic testing that identified an ALS-spectrum gene mutation.
Scenario 2: has a first degree relative who was/is an obligate carrier of a familial ALS-spectrum gene mutation.
Scenario 3: has a first degree relative who has/had an ALS-spectrum diagnosis who had a confirmed ALS-spectrum gene mutation or comes from a family with a high burden of ALS-spectrum diagnoses and a known ALS-spectrum gene mutation.
Scenario 4: is deemed to be at high risk for carrying an ALS-spectrum gene mutation as judged by a review of the family structure and genetic information by the study team.
Willing to undergo genetic analysis, with option of whether or not to learn results
Willing to travel to Columbia University Irving Medical Center (CUIMC) every 6-24 months for study procedures
Capable of providing informed consent and following study procedures, or has a legally authorized representative who is able to consent for the subject.

Exclusion

Known HIV
Known hepatitis B
Known hepatitis C

What this trial measures

  • Time to emergence of symptoms attributable to gene mutationsUp to 10 years

    Emergence of symptoms will defined by the development of any of the following: a) any weakness on neurological examination, b) evidence of nerve loss on electromyography (EMG)-nerve conduction studies, or c) evidence of cognitive impairment on the ECAS or ALS-Cognitive Behavioral Scale (ALS-CBS).