Process for differential diagnosis of Alzheimer's dementia and device therefor
AssigneeSyn X Pharma, Inc.
InventorsGeorge Jackowski, Miyoko Takahashi
Life of this patent
Estimating the term…
Abstract
A method for diagnosing Alzheimer's disease(AD) is disclosed. The method involves directly detecting the presence of a biochemical marker, specifically human glutamine synthetase, in bodily fluid, preferably blood or a blood product. The detection is by an immunoassay incorporating an antibody specific to human glutamine synthetase. In addition, a method for distinguishing between AD and non-AD dementia is disclosed.
Claims43
A method for diagnosing and differentiating Alzheimer's dementia in a mammal comprising:
- obtaining a sample of body fluid from said mammal;
- contacting said sample with at least one antibody which specifically binds to a biochemical marker of Alzheimer's disease;
- determining a presence of said biochemical marker in said sample;
- and
- correlating the presence of said biochemical marker with the occurrence of Alzheimer's dementia.
A method for distinguishing Alzheimer's dementia from non-AD dementia in a mammal exhibiting clinical manifestations indicative of dementia, comprising:
- obtaining a sample of a body fluid from said mammal;
- contacting said sample with at least one antibody having specific binding properties for a biochemical marker of Alzheimer's disease;
- measuring a level of said biochemical marker in said sample;
- and
- correlating said measured level of said biochemical marker with statistically significant levels indicative of Alzheimer's and non-Alzheimer's dementia;
- whereby a differential diagnosis between AD and nonAD dementia is determined.
A diagnostic kit for diagnosing and monitoring the progression of Alzheimer's dementia comprising:
- at least one antibody which is specific for at least one marker indicative of Alzheimer's dementia, said antibody or marker immobilized on a solid support;
- and at least one labeled antibody, which binds to said marker;
- whereby at least one analysis to determine a presence of a marker, an antibody specific thereto, or their immunologically detectable fragments, is carried out on a sample of a body fluid.
A hybridoma cell line 1G3 deposited with American Type Culture Collection under Accession Number PTA-3339.
A monoclonal antibody produced from hybridoma cell line 1G3 deposited with American Type Culture Collection under Accession Number PTA-3339.
A method of detecting human glutamine synthetase in a sample using a monoclonal antibody produced from hybridoma cell line 1G3, deposited with American Type Culture Collection under Accession Number PTA-3339, which comprises contacting the sample with the monoclonal antibody to effect an immunoreaction between the glutamine synthetase in the sample and the monoclonal antibody;
- and detecting the immunoreaction.
A hybridoma cell line 5G4, deposited with American Type Culture Collection under Accession Number PTA-3340.
A monoclonal antibody produced from hybridoma cell line 5G4 deposited with American Type Culture Collection under Accession Number PTA-3340.
A method of detecting human glutamine synthetase in a sample using a monoclonal antibody produced from hybridoma cell line 5G4, deposited with American Type Culture Collection under Accession Number PTA-3340, which comprises contacting the sample with the monoclonal antibody to effect an immunoreaction between the glutamine synthetase in the sample and the monoclonal antibody;
- and detecting the immunoreaction.
Polyclonal antibodies produced against human glutamine synthetase in at least one animal host.
An antibody that specifically binds human glutamine synthetase or immunologically detectable fragments thereof.
A method for diagnosing and differentiating Alzheimer's dementia and the progression thereof in a mammal comprising:
- obtaining a sample of body fluid from said mammal;
- contacting said sample with at least one antibody or antibody fragment selected from the group consisting of antibodies which have specific binding properties for at least one biochemical marker protein selected from the group consisting of the beta isoform of S-100 protein, neuron specific enolase (NSE), and glutamine synthetase (GS) or immunologically detectable fragments thereof, said antibodies capable of being immobilized on a solid support;
- further contacting said sample with at least one labeled antibody, wherein each of said labeled antibodies have an affinity for one of said selected biochemical marker proteins,
- whereby at least one analysis to determine and measure a presence of each of said markers, an antibody specific thereto, or their immunologically detectable fragments, is carried out on a sample of a body fluid;
- determining a presence of each said selected biochemical marker proteins in said sample;
- and
- correlating the presence of each of said selected biochemical marker proteins with the occurrence of Alzheimer's dementia.
A method for distinguishing Alzheimer's dementia from non-AD dementia in a mammal exhibiting clinical manifestations indicative of dementia, comprising:
- obtaining a sample of a body fluid from said mammal;
- contacting said sample with at least one antibody or antibody fragment selected from the group consisting of antibodies which have specific binding properties for at least one biochemical marker protein selected from the group consisting of the beta isoform of S-100 protein, neuron specific enolase (NSE), and glutamine synthetase (GS) or immunologically detectable fragments thereof, said antibodies capable of being immobilized on a solid support;
- measuring a level of said selected biochemical marker protein in said sample;
- and
- correlating said measured level of said selected biochemical marker protein with statistically significant levels indicative of Alzheimer's and non-Alzheimer's dementia;
- whereby a differential diagnosis between AD and non-AD dementia is determined.
A diagnostic kit for diagnosing and monitoring the progression of Alzheimer's dementia comprising:
- from one to three antibodies which are specific for each of three different marker proteins, said antibodies capable of being immobilized on a solid support, wherein
- a. a first marker protein is the beta isoform of S100 protein and a first antibody or antibody fragment is specific therefor,
- b. a second marker protein is neuron specific enolase and a second antibody or antibody fragment is specific therefor,
- c. a third marker protein is glutamine synthetase (GS) and a third antibody or antibody fragment is specific therefor,
- d. from one to three labeled antibodies, each of said labeled antibodies binding to one of said marker proteins, and
- e. means for comparing each of said three marker proteins to specific threshold values of each of said marker proteins to determine the presence of statistically significant concentrations thereof of at least about two standard deviations above normal levels;
- whereby at least one analysis to determine a presence of at least one marker, an antibody specific thereto, or their immunologically detectable fragments, is carried out on a sample of a body fluid;
- wherein said step of comparing said three markers confirms the occurrence of Alzheimer's dementia.
Dependencies are inferred from the claim text.