Claims
- 1-41. (canceled).
- 42. A method for diagnosing probable Alzheimer's disease in a patient, the method comprising:
measuring the amount of one or more soluble amyloid-β peptide (x-≧41) (“Aβ(x-≧41)”) in a cerebrospinal fluid sample of the patient; comparing the measured amount of the soluble Aβ(x-≧41) with a predetermined indicator value of the Aβ(x-≧41); measuring the amount of tau in a cerebrospinal fluid sample of the patient; comparing the measured amount of tau with a predetermined indicator value of tau; and assessing patient status based on a difference between the measured amounts and predetermined indicator values, wherein a measured amount at or below the Aβ(x-≧41) indicator value and at or above the tau indicator value provides a positive indication in the diagnosis of probable Alzheimer's disease, and wherein a measured amount above the Aβ(x-≧41) indicator value and below the tau indicator value provides a negative indication in the diagnosis of probable Alzheimer's disease.
- 43. The method of claim 42 wherein the amount of the soluble Aβ(x-≧41) is measured by:
capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for an epitope within a junction region of Aβ disposed between amino acids 13-26; and detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment specific for Aβ(x-≧41).
- 44. The method of claim 42 wherein the amount of the soluble Aβ(x-≧41) is measured by:
capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for Aβ(x-≧41); and detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment that recognizes Aβ.
- 45. The method of claim 42 wherein the amount of the soluble Aβ(x-≧41) is measured by:
capturing the soluble Aβ(x-≧41) from the sample on a solid phase with a first antibody or antibody fragment specific for Aβ; and detecting capture of the soluble Aβ(x-≧41) using a second antibody or antibody fragment specific for Aβ(x-≧41).
- 46. The method of claim 42 wherein Aβ(x-≧41) is Aβ(x-42).
- 47. The method of claim 43 wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.
- 48. The method of claim 43 wherein the first antibody or antibody fragment has the specificity of an antibody raised against Aβ13-28.
- 49. The method of claim 43 wherein the second antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.
- 50. The method of claim 44 wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.
- 51. The method of claim 44 wherein the first antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.
- 52. The method of claim 44 wherein the second antibody or antibody fragment is specific for an epitope within a junction region of Aβ disposed between amino acids 13-26.
- 53. The method of claim 45 wherein the detecting step comprises detecting binding between the second antibody or antibody fragment and Aβ(x-≧41) using a third labeled antibody or antibody fragment that recognizes the second antibody or antibody fragment but not the first antibody or antibody fragment.
- 54. The method of claim 45 wherein the second antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.
- 55. The method of claim 47 wherein the label is an enzymatic label.
- 56. The method of claim 49 wherein the first antibody or antibody fragment has the specificity of an antibody raised against Aβ13-28.
- 57. The method of claim 50 wherein the label is an enzymatic label.
- 58. The method of claim 52 wherein the second antibody or antibody fragment has the specificity of an antibody raised against Aβ13-28.
- 59. The method of claim 53 wherein the label is an enzymatic label.
- 60. A kit comprising:
a first antibody or antibody fragment specific for Aβ(x-≧41) that does not cross-react with Aβ(x-≦40) and a second antibody or antibody fragment specific for tau.
- 61. The kit of claim 60 wherein the first antibody or antibody fragment has the specificity of an antibody raised against amino acids 33-42 of Aβ.
- 62. The kit of claim 60 further comprising a third antibody or antibody fragment specific for Aβ.
- 63. The kit of claim 60 wherein Aβ(x-≧41) is Aβ(x-42).
- 64. The kit of claim 60 wherein the first antibody and second antibody are whole immunoglobulins.
- 65. The kit of claim 60 further comprising a third antibody or antibody fragment that is labeled and that is specific for tau.
- 66. The kit of claim 62 wherein the third antibody or antibody fragment is specific for an epitope within a junction region of Aβ disposed between amino acids 13-26.
- 67. The kit of claim 62 further comprising a fourth labeled antibody or antibody fragment that recognizes the first antibody or antibody fragment but not the third antibody or antibody fragment.
- 68. The kit of claim 62 further comprising a fourth labeled antibody or antibody fragment that recognizes the third antibody or antibody fragment but not the first antibody or antibody fragment.
- 69. The kit of claim 66 wherein the third antibody or antibody fragment has the specificity of an antibody raised against Aβ13-28.
- 70. The kit of claim 67 wherein the label is an enzymatic label.
- 71. The kit of claim 68 wherein the label is an enzymatic label.
- 72. The method of claim 51 wherein the second antibody or antibody fragment recognizes an N-terminal region of Aβ.
- 73. The method of claim 54 wherein the first antibody or antibody fragment recognizes an N-terminal region of Aβ.
- 74. The kit of claim 62 wherein the third antibody or antibody fragment recognizes an N-terminal region of Aβ.
- 75. The method of claim 72 wherein the second antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.
- 76. The method of claim 73 wherein the first antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.
- 77. The kit of claim 74 wherein the third antibody or antibody fragment recognizes an epitope within amino acids 1-16 of Aβ.
Parent Case Info
[0001] This application is related to co-pending applications Ser. No. 07/965,972, filed Oct. 26, 1992, Ser. No. 08/079,511, filed Jun. 17, 1993, and Ser. No. 08/339,141, filed Nov. 14, 1994, all of which are incorporated herein by reference.
Divisions (2)
|
Number |
Date |
Country |
Parent |
08466554 |
Jun 1995 |
US |
Child |
10877688 |
Jun 2004 |
US |
Parent |
08419008 |
Apr 1995 |
US |
Child |
08466554 |
Jun 1995 |
US |
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
08339141 |
Nov 1994 |
US |
Child |
08419008 |
Apr 1995 |
US |