METHODS AND COMPOSITIONS FOR DIAGNOSIS, STRATIFICATION, AND MONITORING OF ALZHEIMER'S DISEASE AND OTHER NEUROLOGICAL DISORDERS IN BODY FLUIDS
First Claim
Patent Images
1. A method of aiding diagnosis of Alzheimer'"'"'s disease (“
- AD”
), comprising comparing a measured level of at least one AD diagnosis biomarker in a biological fluid sample from an individual to a reference level for the biomarker, wherein the AD diagnosis biomarker is selected from the group consisting of GCSF;
IFN-g;
IGFBP-1;
BMP-6;
BMP-4;
Eotaxin-2;
IGFBP-2;
TARO;
RANTES;
ANG;
PARC;
Acrp30;
AgRP(ART);
TIMP-1;
TIMP-2;
ICAM-1;
TRAIL R3;
uPAR;
IGFBP-4;
LEPTIN(OB);
PDGF-BB;
EGF;
BDNF;
NT-3;
NAP-2;
IL-1ra;
MSP-a;
SCF;
TGF-b3;
TNF-b;
MIP-1d;
IL-3;
FGF-6;
IL-6 R;
sTNF RII;
AXL;
bFGF;
FGF-4;
CNTF;
MCP-1;
MIP-1b;
TPO;
VEGF-B;
IL-8;
FAS;
EGF-R.
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Accused Products
Abstract
The inventors have discovered a collection of proteinaceous biomarkers (“AD biomarkers) which can be measured in peripheral biological fluid samples to aid in the diagnosis of neurodegenerative disorders, particularly Alzheimer'"'"'s disease and mild cognitive impairment (MCI). The invention further provides methods of identifying candidate agents for the treatment of Alzheimer'"'"'s disease by testing prospective agents for activity in modulating AD biomarker levels.
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Citations
34 Claims
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1. A method of aiding diagnosis of Alzheimer'"'"'s disease (“
- AD”
), comprising comparing a measured level of at least one AD diagnosis biomarker in a biological fluid sample from an individual to a reference level for the biomarker, wherein the AD diagnosis biomarker is selected from the group consisting of GCSF;
IFN-g;
IGFBP-1;
BMP-6;
BMP-4;
Eotaxin-2;
IGFBP-2;
TARO;
RANTES;
ANG;
PARC;
Acrp30;
AgRP(ART);
TIMP-1;
TIMP-2;
ICAM-1;
TRAIL R3;
uPAR;
IGFBP-4;
LEPTIN(OB);
PDGF-BB;
EGF;
BDNF;
NT-3;
NAP-2;
IL-1ra;
MSP-a;
SCF;
TGF-b3;
TNF-b;
MIP-1d;
IL-3;
FGF-6;
IL-6 R;
sTNF RII;
AXL;
bFGF;
FGF-4;
CNTF;
MCP-1;
MIP-1b;
TPO;
VEGF-B;
IL-8;
FAS;
EGF-R. - View Dependent Claims (2, 3, 4, 5, 6)
- AD”
-
7. A method of aiding diagnosis of Alzheimer'"'"'s disease (“
- AD”
), comprising;comparing a measured level of at least one AD diagnosis biomarker in a biological sample fluid sample from an individual to a reference level for the biomarker wherein the AD diagnosis biomarker is selected from the group consisting BTC;
SDF-1;
MCP-2;
IFN-gamma;
IGFBP-4;
IGF-1SR;
IL-8;
GM-CSF; and
ANG-2. - View Dependent Claims (8, 9, 10, 11, 12)
- AD”
-
13. A method of aiding diagnosis of Alzheimer'"'"'s disease (“
- AD”
), comprising;comparing a measured level of at least one AD diagnosis biomarker in a biological sample fluid sample from an individual to a reference level for the biomarker wherein the AD diagnosis biomarker is selected from the group consisting of TNF RII;
MSP-alpha;
uPAR;
TPO;
MIP-1beta;
VEGF-beta;
FAS;
MCP-1;
NAP-2;
ICAM-1;
TRAIL R3;
PARC;
ANG;
IL-3;
MIP-1delta;
IFN-gamma;
IL-8; and
FGF-6. - View Dependent Claims (14, 15, 16, 17, 19)
- AD”
-
18. A method of aiding diagnosis of Alzheimer'"'"'s disease (“
- AD”
), comprising;comparing a measured level of at least one AD diagnosis biomarker in a biological sample fluid sample from an individual to a reference level for the biomarker wherein the AD diagnosis biomarker is selected from the group consisting of lymphotactin and IL-11.
- AD”
- 20. A method for monitoring progression of Alzheimer'"'"'s disease (AD) in an AD patient, comprising comparing a measured level of at least one AD diagnosis biomarker in a biological sample fluid sample from an individual to a reference level for the biomarker wherein the AD diagnosis biomarker is selected from the group consisting of lymphotactin and IL-11.
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23. A method for stratifying Alzheimer'"'"'s disease (AD) in an individual, comprising:
comparing a measured level of at least one AD diagnosis biomarker in a biological sample from the individual with a reference level for the at least one biomarker, wherein the at least one biomarker is selected from the group consisting of lymphotactin and IL-11. - View Dependent Claims (24)
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25. A kit for use in aiding in the diagnosis of AD, wherein the kit comprises at least one reagent specific for at least one AD diagnosis marker, wherein said at least one AD diagnosis biomarker is selected from the group consisting of BTC;
- SDF-1;
MCP-2;
IFN-gamma;
IGFBP-4;
IGF-1SR;
IL-8;
GM-CSF; and
ANG-2, and instructions for carrying out a method of aiding in the diagnosis of AD. - View Dependent Claims (26)
- SDF-1;
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27. A kit for use in aiding in the diagnosis of AD, wherein the kit comprises at least one reagent specific for at least one AD diagnosis marker, wherein said at least one AD diagnosis biomarker is selected from the group consisting of sTNF RII;
- MSP-alpha;
uPAR;
TPO;
MIP-1beta;
VEGF-beta;
FAS;
MCP-1;
NAP-2;
ICAM-1;
TRAIL R3;
PARC;
ANG;
IL-3;
MIP-1delta;
IFN-gamma;
IL-8; and
FGF-6, and instructions for carrying out a method of aiding in the diagnosis of AD.
- MSP-alpha;
- 28. A kit for use in aiding in the diagnosis of AD, wherein the kit comprises at least one reagent specific for at least one AD diagnosis marker, wherein said at least one AD diagnosis biomarker is selected from the group consisting of the biomarkers lymphotactin and IL-11, and instructions for carrying out a method of aiding in the diagnosis of AD.
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32. A method for identifying at least one biomarker useful for the diagnosis of a neurological disease, comprising:
obtaining measured values from a set of peripheral biological fluid samples for a plurality of biomarkers, wherein said set of peripheral biological fluid samples is divisible into subsets on the basis of a neurological disease;
comparing the measured values from each subset for at least one biomarker; and
identifying at least one biomarker for which the measured values are significantly different between the subsets.- View Dependent Claims (33)
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34. A method of aiding diagnosis of a neurodegenerative disease comprising obtaining measured values of one or more biomarkers shown in Table 12A-12B with a q-value % of less than 1.5, and comparing the measured value to a reference value.
Specification