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sCD163 in ALS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02325375
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive muscle weakness leading to severe disability and eventually death.Since the diagnosis relies on clinical features and electromyographic abnormalities, which may occur rather late in the disease course, there is a need to identify diagnostic tests that can confirm or exclude the diagnosis of ALS in the earlier phase of the disease.

More recently, there are studies suggesting neuroinflammation to play a role for the development of ALS. Cluster of differentiation 163 is found to be up regulated in a large range of inflammatory diseases.

At the investigators lab, pilot data (Kallestrup M et al, unpublished data) has shown promising results. There was an increased level of cluster of differentiation 163 (sCD163) in cerebrospinal fluid in 7 patients with ALS compared with controls.

The purpose of the investigators study is to define the concentration of sCD163 in the cerebrospinal fluid and serum in patients with ALS compared with controls (patients with unspecified neurological symptoms). Furthermore, the investigators will define the concentrations of protein, glucose, immunoglobulin G index and other factors in the spinal fluid.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Procedure: lumbar puncture for spinal fluid and blood sample

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Study Type : Observational
Actual Enrollment : 20 participants
Official Title: Inflammation in Amyotrophic Lateral Sclerosis - a Study of Soluble Cluster of Differentiation 163 in the Cerebrospinal Fluid
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Group/Cohort Intervention/treatment
ALS newly diagnosed Procedure: lumbar puncture for spinal fluid and blood sample
lumbar puncture for spinal fluid and blood sample

ALS treated Procedure: lumbar puncture for spinal fluid and blood sample
lumbar puncture for spinal fluid and blood sample

controls Procedure: lumbar puncture for spinal fluid and blood sample
lumbar puncture for spinal fluid and blood sample




Primary Outcome Measures :
  1. Concentrations of sCD-163 in patients with ALS. [ Time Frame: day 1 ]
  2. Concentration of sCD163 in newly diagnosed compared with established ALS [ Time Frame: day 1 ]

Biospecimen Retention:   Samples Without DNA
spinal fluid and blood sample for identification of different factors


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ALS, treated or newly diagnosed
Criteria

Inclusion Criteria:

  • ALS and controls(lumbar puncture at our department)

Exclusion Criteria:

  • <18 years
  • Other CNS disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325375


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus

Additional Information:
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02325375    
Other Study ID Numbers: ALS CD163
1-10-72-348-14 ( Other Identifier: The National Committee on Health Research Ethics (Denmark) )
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: December 2014
Keywords provided by University of Aarhus:
Amyotrophic Lateral Sclerosis
spinal fluid
CD163
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases