Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders
Overview
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.
Primary outcome measures
- Blood Collection [Time frame: 50 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT05474235 · 07-005711 · 5P01NS084974