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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2038-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Blood Relative of ALS Patient

Subjects with family history (first, second or third degree blood relative) of ALS or other motor neuron disease.

No interventions assigned to this group

Healthy Control

Subjects with no personal or family history (first, second or third degree blood relative) of ALS or other motor neuron disease

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes