Csf Diagnostic in Vitro Method for Diagnosis of Dementias and Neuroinflammatory Diseases

Abstract

CSF diagnostic in vitro method for the diagnosis of dementias and neuroinflammatory diseases, in which a determination of the procalcitonin immunoreactivity (PCT immunoreactivity) is carried out in a sample of cerebrospinal fluid (CSF) of a patient who is suffering from a dementia or neuroinflammatory disease or is suspected of suffering from such a disease. Conclusions about the presence, the course, the severity or the success of a treatment of the dementia or neuroinflammatory disease are drawn from a measured PCT immunoreactivity which is above a threshold value typical for healthy individuals.

1 . A CSF diagnostic in vitro method for detection, determination of severity and monitoring and prognosis of dementias and neuroinflammatory diseases, wherein a determination of the procalcitonin immunoreactivity (PCT immunoreactivity) is carried out in a sample of the cerebrospinal fluid (CSF) of a patient who is suffering from a dementia or neuroinflammatory disease or is suspected of suffering from such a disease, and conclusions about the presence, the course, the severity or the success of a treatment of the dementia or neuroinflammatory disease are drawn from a measured PCT immunoreactivity which is above a threshold value typical for healthy control persons. 
     
     
         2 . The method according to  claim 1 , wherein the PCT immunoreactivity is determined with the aid of a highly sensitive PCT immunoassay having a functional assay sensitivity (FAS) of better than 100 ng of PCT per 1 (100 ng/l or 100 pg/ml), preferably better than 10 ng/l. 
     
     
         3 . The method according to  claim 1 , wherein an average value which is determined for healthy control persons and is about 50 pg/ml is used as a threshold value for the diagnosis “suspicion of neuroinflammatory disease”. 
     
     
         4 . The method according to  claim 1 , wherein the PCT immunoassay for measurement of the PCT immunoreactivity is a sandwich immunoassay using two antibodies which bind to those segments of the complete PCT peptide which are located on different members of the PCT partial peptides formed in the proteolytic processing of PCT with formation of calcitonin or which are located on PCT partial peptides which do not comprise the calcitonin sequence. 
     
     
         5 . The method according to  claim 4 , wherein one of the antibodies binds to a segment of the calcitonin sequence and the other of the antibodies binds to a segment of the katacalcin sequence, and in that at least one of the two antibodies is an affinity-purified polyclonal antibody. 
     
     
         6 . The method according to  claim 1 , wherein the dementia is a presenile dementia selected from the group consisting of Alzheimer's dementia (AD), dementia with Lewy bodies (DLB), frontotemporal dementia (FTD) and various forms of vascular dementia (VAD), and in that the method is carried out as part of differential diagnosis. 
     
     
         7 . The method according to  claim 6 , wherein the method is carried out as a differential diagnostic method in which the measured PCT immunoreactivity values are related to value ranges typical for the individual forms of dementia and a probability of the presence of one of the possible forms of dementia is determined. 
     
     
         8 . The method according to  claim 1 , wherein the neuroinflammatory disease is a chronic neuroinflammatory disease of non-infectious aetiology. 
     
     
         9 . The method according to  claim 1 , wherein said method is carried out as part of a multi-parameter determination in which at least one further biochemical or physiological parameter informative for the respective clinical picture is simultaneously determined and in which the measured result is obtained in the form of a set of at least two measured variables which is evaluated for the fine diagnosis of dementia or neuroinflammatory disease. 
     
     
         10 . The method according to  claim 9 , wherein, as part of the multi-parameter determination, in addition to the PCT immunoreactivity, at least one further inflammation mediator is determined which is selected from the group consisting of complement components, cytokines, chemokines, blood coagulants and fibrinolytic factors, acute-phase proteins and free radical compounds. 
     
     
         11 . The method according to  claim 9 , wherein the multi-parameter determination is carried out as a simultaneous determination by means of a chip technology measuring apparatus or an immunochromatographic measuring apparatus. 
     
     
         12 . The method according to  claim 9 , wherein the evaluation of the complex measured result of the multi-parameter determination is effected with the aid of a computer program. 
     
     
         13 . (canceled)