Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS)

Completed

Conditions studied: Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease, Primary Lateral Sclerosis, Nervous System Diseases, Hereditary Spastic Paraparesis

In brief

The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as other neurodegenerative diseases and from people with no neurological disorder. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to diagnose ALS and monitor disease progression. Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis. Studying components of the blood, such as DNA, may help us understand what happens when genes function abnormally and how it might be related to disease.

Key facts

Study ID

NCT00677768

Run by

Massachusetts General Hospital

People needed

475

Starts

2008-04-01

Expected to finish

2015-11-01

Last updated by the study team

2016-06-03

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of possible (excluding volunteers with UMN signs ONLY), probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to revised El Escorial criteria
• Disease duration of less than or equal to two years from symptom onset
• Age 30-80 years at the time of disease onset
• Ability to provide informed consent
• Ability to comply with study procedures
• Medically safe to have lumbar puncture (lumbar puncture volunteers only)

You may not qualify if…

• Clinical evidence of chronic liver or renal failure
• Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
• Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
• Suspected ALS (PMND) Volunteers
• Inclusion Criteria:
• Diagnosis of suspected ALS defined as presence of UMN or LMN signs alone and the diagnosis of Clinically Probably Laboratory-Supported ALS CANNOT be proven by evidence in clinical grounds in conjunction with electrodiagnostic, neurophysiologic, neuroimaging or clinically laboratory studies
• Disease duration of less than or equal to four years from symptom onset
• Age 30-80 years at time of disease onset
• Ability to provide informed consent
• Ability to comply with study procedures
• Medically safe to have lumbar puncture (lumbar puncture volunteers only)
• Exclusion Criteria:
• Clinical evidence of chronic liver or renal failure
• Genetically confirmed diagnosis of hereditary spastic paraparesis or spinal motor atrophy (SMA) disease
• Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
• Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
• Neurological Disease Mimic Volunteers
• Inclusion Criteria:
• Diagnosis of one of the following:
• Pure Lower Motor Neuron Disease (LMND) mimics:
• Multi-focal motor neuropathy
• Autoimmune motor neuropathy
• Cervical or lumbosacral radiculopathies
• Peripheral mononeuropathies:
• Ulnar neuropathy

Where it is running

• Phoenix Neurological Associates, Ltd. — Phoenix, Arizona, United States
• University of California Irvine — Orange, California, United States
• Mayo Clinic Neurology — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Saint Mary's Healthcare — Grand Rapids, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Robert Wood Johnson/UMDNJ — New Brunswick, New Jersey, United States
• Upstate Clinical Research, LLC — Albany, New York, United States
• Beth Israel Medical Center, PACC — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Carolinas Health Care — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• OSU Medical Center — Columbus, Ohio, United States
• Providence ALS Clinic — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Pennsylvania State University — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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