NCT05474235 · Mayo Clinic
Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
What this study is about
The purpose of this study is to collect, from patients with sporadic and familial ALS and their family members, clinical data and blood samples for extraction of DNA, RNA, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to ALS pathogenesis.
View original scientific description
The purpose of this study is to collect, from patients with sporadic and familial ALS and their family members, clinical data and blood samples for extraction of DNA, RNA, preparation of lymphocytes, plasma and serum to establish a repository for future investigations of genetic contributions to ALS pathogenesis. Blood samples for DNA extraction also would be collected from control subjects with no personal or family history of ALS phenotypes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations