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OpenTrials
Recruiting

NCT Number: NCT05474235

Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Location contact

Chris Liriano

CONTACT

[email protected]

904-953-5325

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Blood Collection

    Time frame: 50 years

    Total number of blood samples collected

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders

Important dates

Study start
2007
Primary completion
2038
Study completion
2038
First posted
Jul 26, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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