IP Library Patent Application 11780447
Patent Application
App. No. 11/780,447

DIAGNOSIS OF MULTIPLE SCLEROSIS AND OTHER DEMYELINATING DISEASES

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Patent No.
US None
App. No.
11/780,447
Abstract

A method of diagnosing multiple sclerosis and other demyelinating diseases or predicting a predisposition to multiple sclerosis and other demyelinating diseases. The method utilizes detection of increased amounts of memory lymphocytes reacting to MS antigens, proinflammatory cytokines, and antibodies against MS antigens.

Claims (21)

1 . A method for diagnosing the likelihood and severity of multiple sclerosis in a patient, comprising the steps of:

a) determining a level of antibodies against α-B-crystallin in a sample from the patient;

b) comparing the level of antibodies determined in step a) with a normal level of the antibodies in control patients;

c) determining an amount of neuronal α-B-crystallin-specific activated T-cells or neuronal-specific memory lymphocytes in a sample from the patient;

d) obtaining a stimulation index from step c); and

e) comparing the stimulation index from step d) with a normal stimulation index, wherein:

(i) a normal level or lower than normal level of both stimulation index and antibodies for said α-B-crystallin indicate control patient conditions;

(ii) higher than normal levels of either stimulation index or antibodies for said α-B-crystallin indicate a possibility of multiple sclerosis; and

(iii) higher than normal levels of both stimulation index and antibodies for said α-B-crystallin indicate a likelihood of multiple sclerosis.

2 . The method according to claim 1 , wherein the normal level of antibodies is calculated by taking a mean of levels of antibodies in individuals without symptoms relating to multiple sclerosis.

3 . The method according to claim 1 , wherein the higher than normal level of antibodies is higher than about two standard deviations of normal level of antibodies of a control group.

4 . The method according to claim 1 , wherein determining the level of antibodies in any or all of steps a) and b) is accomplished using an immunoassay.

5 . The method according to claim 4 , wherein the immunoassay is an enzyme-linked immunosorbent assay.

6 . The method according to claim 1 , wherein the antibodies are selected from the group consisting of IgG, IgA, and IgM.

7 . The method according to claim 1 , wherein the normal stimulation index is calculated by taking a mean of stimulation indices in individuals without symptoms relating to multiple sclerosis.

8 . The method according to claim 1 , wherein the higher than normal stimulation index is higher than about two standard deviations of normal stimulation index of a control group.

9 . The method according to claim 1 , wherein the T-cells are antigen-specific CD3 activated T-cells.

10 . The method of claim 1 , further comprising a step of obtaining a clinical test result selected from the group consisting of MRI, evoked response, and cerebrospinal fluid.

11 . The method of claim 1 , further comprising a step of obtaining at least two clinical test results selected from the group consisting of MRI, evoked response, and cerebrospinal fluid.

12 . The method of claim 1 , further comprising a step of obtaining clinical test results of MRI, evoked response, and cerebrospinal fluid.

13 . The method of claim 1 , wherein the diagnosis is made according to Table 2.