Clinical trial NCT05474235: Studies in Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Motor Neuron Disorders
Official title: Clinical & Genetic Studies in ALS and Other Neurodegenerative Motor Neuron Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-07-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: Blood Collection
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bjorn Oskarsson, MD
role: PRINCIPAL_INVESTIGATOR
References: