Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03865420
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria for participation in biosample portion of the study:
* Known HIV
* Known hepatitis B
* Known hepatitis C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
105 Years
Study:
NCT03865420
Study Brief:
Protocol Section:
NCT03865420