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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05474235

Enrollment

3000

Registered

2022-07-26

Start date

2007-12-01

Completion date

2038-12-01

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood Collection	50 years	Total number of blood samples collected

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBjorn Oskarsson, MD

Mayo Clinic

Outcome results