sCD163 in ALS Patients

NCT02325375 | Completed DMC

• 2 other identifiers: ALS CD1631-10-72-348-14
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 At the investigators lab, pilot data (Kallestrup M et al, unpublished data) has shown promising results.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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; spinal fluid; CD163

Outcome Measures

Primary Outcomes (2)

• Concentrations of sCD-163 in patients with ALS.

  day 1

• Concentration of sCD163 in newly diagnosed compared with established ALS

  day 1

Study Arms (3)

ALS newly diagnosed

Procedure: lumbar puncture for spinal fluid and blood sample

ALS treated

Procedure: lumbar puncture for spinal fluid and blood sample

controls

Procedure: lumbar puncture for spinal fluid and blood sample

Interventions

lumbar puncture for spinal fluid and blood sample PROCEDURE

lumbar puncture for spinal fluid and blood sample

ALS newly diagnosed; ALS treated; controls

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALS, treated or newly diagnosed

You may qualify if:

• ALS and controls(lumbar puncture at our department)

You may not qualify if:

• \<18 years
• Other CNS disease

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (10)

• Vucic S, Rothstein JD, Kiernan MC. Advances in treating amyotrophic lateral sclerosis: insights from pathophysiological studies. Trends Neurosci. 2014 Aug;37(8):433-42. doi: 10.1016/j.tins.2014.05.006. Epub 2014 Jun 11.

  PMID: 24927875 BACKGROUND

• Menon P, Kiernan MC, Vucic S. Biomarkers and future targets for development in amyotrophic lateral sclerosis. Curr Med Chem. 2014;21(31):3535-50. doi: 10.2174/0929867321666140601161148.

  PMID: 24934359 BACKGROUND

• Liao B, Zhao W, Beers DR, Henkel JS, Appel SH. Transformation from a neuroprotective to a neurotoxic microglial phenotype in a mouse model of ALS. Exp Neurol. 2012 Sep;237(1):147-52. doi: 10.1016/j.expneurol.2012.06.011. Epub 2012 Jun 23.

  PMID: 22735487 BACKGROUND

• Evans MC, Gaillard PJ, de Boer M, Appeldoorn C, Dorland R, Sibson NR, Turner MR, Anthony DC, Stolp HB. CNS-targeted glucocorticoid reduces pathology in mouse model of amyotrophic lateral sclerosis. Acta Neuropathol Commun. 2014 Jun 13;2:66. doi: 10.1186/2051-5960-2-66.

  PMID: 24923195 BACKGROUND

• Italiani P, Carlesi C, Giungato P, Puxeddu I, Borroni B, Bossu P, Migliorini P, Siciliano G, Boraschi D. Evaluating the levels of interleukin-1 family cytokines in sporadic amyotrophic lateral sclerosis. J Neuroinflammation. 2014 May 23;11:94. doi: 10.1186/1742-2094-11-94.

  PMID: 24884937 BACKGROUND

• Dumont AO, Goursaud S, Desmet N, Hermans E. Differential regulation of glutamate transporter subtypes by pro-inflammatory cytokine TNF-alpha in cortical astrocytes from a rat model of amyotrophic lateral sclerosis. PLoS One. 2014 May 16;9(5):e97649. doi: 10.1371/journal.pone.0097649. eCollection 2014.

  PMID: 24836816 BACKGROUND

• Noh MY, Cho KA, Kim H, Kim SM, Kim SH. Erythropoietin modulates the immune-inflammatory response of a SOD1(G93A) transgenic mouse model of amyotrophic lateral sclerosis (ALS). Neurosci Lett. 2014 Jun 27;574:53-8. doi: 10.1016/j.neulet.2014.05.001. Epub 2014 May 10.

  PMID: 24820540 BACKGROUND

• Kjaergaard AG, Rodgaard-Hansen S, Dige A, Krog J, Moller HJ, Tonnesen E. Monocyte expression and soluble levels of the haemoglobin receptor (CD163/sCD163) and the mannose receptor (MR/sMR) in septic and critically ill non-septic ICU patients. PLoS One. 2014 Mar 17;9(3):e92331. doi: 10.1371/journal.pone.0092331. eCollection 2014.

  PMID: 24637679 BACKGROUND

• Etzerodt A, Moestrup SK. CD163 and inflammation: biological, diagnostic, and therapeutic aspects. Antioxid Redox Signal. 2013 Jun 10;18(17):2352-63. doi: 10.1089/ars.2012.4834. Epub 2012 Oct 19.

  PMID: 22900885 BACKGROUND

• Moller HJ. Soluble CD163. Scand J Clin Lab Invest. 2012 Feb;72(1):1-13. doi: 10.3109/00365513.2011.626868. Epub 2011 Nov 7.

  PMID: 22060747 BACKGROUND

Related Links

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Biospecimen

Retention: SAMPLES WITHOUT DNA

spinal fluid and blood sample for identification of different factors

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Spinal Puncture; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 25, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 16, 2016

Record last verified: 2014-12

Locations

DK (1)