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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT01699451
Eligibility Criteria:
Inclusion Criteria:
* ALS Patient
1. Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features
2. \> or = 18 years of age and willing to provide consent, or assent, if unable to consent
* Subject with family history of ALS or other relevant neurodegenerative disease
1. No personal history of ALS, ALS-FTD or other motor neuron disease
2. Family history of ALS, ALS-FTD in a first, second or third degree blood relative
3. \> or = 18 years of age and willing to provide consent
* Control
1. No personal or family history (first or second degree blood relative) of ALS, dementia, Parkinson disease or other relevant neurodegenerative disorder
2. \> or = 18 years of age and willing to provide consent
Exclusion Criteria:
* ALS Subject and subject with family history of ALS/ALS-FTD or other neurodegenerative motor neuron disorder but no personal history of such conditions
1. History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be contributed to by an acquired condition
2. Limited mental capacity rendering the subject unable to comply with skin punch biopsy or standard phlebotomy procedures
3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
* Healthy Control Subject
1. Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.)
2. Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures
3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01699451
Study Brief:
Protocol Section:
NCT01699451