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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT05474235
Eligibility Criteria:
Inclusion Criteria
ALS or Suspected ALS Patient
* 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; OR
* Blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features; OR:
* A clinical suspicion or referral for ALS;
* \> 18 years of age;
* Willing and able to give signed informed consent or assent that has been approved by the Institutional Review Board (IRB).
Blood Relative of ALS Patient
* Family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
* \> 18 years of age;
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
Healthy Control
* No personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease;
* \> 18 years of age;
* No personal history of other neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease);
* Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
Exclusion Criteria:
ALS or Suspected Patient • Limited mental capacity rendering the subject unable to provide written informed consent or assent or comply with standard phlebotomy procedures.
Blood Relative of ALS Patient
• Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
Healthy Control Subject
* Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.);
* Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05474235
Study Brief:
Protocol Section:
NCT05474235