Amyotrophic Lateral SclerosisNCT05474235
Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
An observational study of Amyotrophic Lateral Sclerosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2038
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Chris Liriano, 904-953-5325, liriano.christion@mayo.edu
About this study
Official title: Clinical & Genetic Studies in 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Collection
Total number of blood samples collected
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study startDec 2007
- Primary completionDec 2038 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Bjorn E. Oskarsson, Mayo Clinic
- Investigators
- Bjorn Oskarsson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474235
- Sponsor's protocol ID
- 07-005711
- Other IDs
- 5P01NS084974
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No