NCT00677768

Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS)

A Multicenter Study for the Validation of ALS Biomarkers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 475 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers with neurological diseases other than ALS. These changes are called biomarkers. Biomarkers for ALS have been found in blood collected in earlier phases of this study. Biomarkers are non-genetic elements in your blood that may help to make diagnosing ALS easier. In the next phase, comparison of these changes in the blood of volunteers with ALS and without ALS will be used to confirm these biomarkers and to develop a tool to diagnose and monitor progression of ALS.

Conditions

• Amyotrophic Lateral Sclerosis
• Lou Gehrig's Disease
• Primary Lateral Sclerosis
• Nervous System Diseases
• Hereditary Spastic Paraparesis

Interventions

Type	Name	Description
OTHER	No intervention	Sample collection

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2008-05-14
• Last updated: 2016-06-03

Locations

30 sites across 2 countries: United States, Canada