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RecruitingNCT05474235Updated Aug 27, 2026

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

An observational study in Amyotrophic Lateral Sclerosis, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Dec 2007; still recruiting 18 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
3,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Amyotrophic Lateral Sclerosis
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In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 106 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Eligible subjects with ALS or suspected ALS or family history of ALS will be identified from patients seen in the Department of Neurology at Mayo Clinic Jacksonville. Inclusion criteria include standardized diagnostic criteria for ALS as used in ALS therapeutic trials and patients with clinically suspected ALS.

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

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.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Blood Collection

    Total number of blood samples collected

    Time frame: 50 years

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05474235
Lead sponsor
Mayo Clinic
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Bjorn E. Oskarsson (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 26, 2022
Start date
Dec 2007
Primary completion
Dec 2038 (estimated)
Completion
Dec 2038 (estimated)
Last update
Aug 27, 2026

Study contacts

Bjorn Oskarsson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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