Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05474235

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT05474235

Start date

Dec, 2007

Status verified date

Aug, 2026

Completion date

Dec, 2038

Anticipated

Primary completion date

Dec, 2038

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

ALS or Suspected ALS Patient

Subjects with clinical diagnosis of possible, laboratory-supported probable, probable or definite, ALS or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features or a blood relative (first, second or third degree) with history of ALS or neurodegenerative disorder with evidence of ALS plus extramotor features.

Blood Relative of ALS Patient

Subjects with family history (first, second or third degree blood relative) of ALS or other motor neuron disease.

Healthy Control

Subjects with no personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease

Primary outcome measure

  • Blood Collection [ Time Frame: 50 years ]

Central Contacts and Locations

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Chris Liriano

904-953-5325liriano.christion@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.