US2005255122A1PendingUtilityA1

Prevention and treatment of amyloidogenic disease

69
Assignee: NEURALAB LTDPriority: Dec 2, 1997Filed: Sep 2, 2004Published: Nov 17, 2005
Est. expiryDec 2, 2017(expired)· nominal 20-yr term from priority
Inventors:Dale B. Schenk
A61K 2039/505A61K 38/193Y10T436/105831A61K 38/1709A61K 2039/55577C07K 16/18A61K 2039/53A61K 39/0007A61K 2039/605A61K 2039/55572A61K 2039/55566G01N 2800/2821A61K 2039/6037A61K 2039/55505
69
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Claims

Abstract

The invention provides compositions and methods for treatment of amyloidogenic diseases. Such methods entail administering an agent that induces a beneficial immune response against an amyloid deposit in the patient. The methods are particularly useful for prophylactic and therapeutic treatment of Alzheimer's disease. In such methods, a suitable agent is Aβ peptide or an antibody thereto.

Claims

exact text as granted — not AI-modified
1 . A method of therapeutically treating a disease characterized by an amyloid deposit of Aβ in a patient having the disease, comprising: 
 administering an Aβ peptide and an adjuvant in a regime effective to induce an immune response comprising antibodies to the Aβ peptide, the adjuvant enhancing the immune response to the Aβ peptide, and thereby therapeutically treat the disease in the patient; wherein the Aβ peptide is selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6.    
     
     
         2 . The method of  claim 1 , wherein the patient is a human.  
     
     
         3 . The method of  claim 1 , wherein the disease is Alzheimer's disease.  
     
     
         4 . The method of any one of claims  1 ,  2  or  3 , wherein the patient is under 50.  
     
     
         5 . The method of any one of claims  1 ,  2  or  3 , wherein the patient has inherited risk factors indicating susceptibility to Alzheimer's disease.  
     
     
         6 . The method of any one of claims  1 ,  2  or  3 , wherein the patient has no known risk factors for Alzheimer's disease.  
     
     
         7 . A method of therapeutically treating a disease characterized by an amyloid deposit of Aβ in a patient having the disease, comprising: 
 administering an Aβ peptide selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6, in a regime effective to induce an immune response comprising antibodies to the Aβ peptide and thereby therapeutically treat the disease in the patient, wherein the dose of the Aβ peptide administered to the patient is at least 50 μg.    
     
     
         8 . The method of  claim 7 , wherein the dose of the Aβ peptide administered to the patient is at least 100 μg.  
     
     
         9 . The method of  claim 7 , wherein the Aβ peptide is administered in aggregated form.  
     
     
         10 . The method of any one of claims  7 ,  8  or  9 , wherein the Aβ peptide is administered orally, subcutaneously, intramuscularly, topically or intravenously.  
     
     
         11 . The method of any one of claims  7 ,  8  or  9 , wherein the Aβ peptide is administered intramuscularly or subcutaneously.  
     
     
         12 . The method of any one of claims  7 ,  8  or  9 , further comprising monitoring the patient for the immune response.  
     
     
         13 . The method of  claim 7 , wherein the adjuvant and the Aβ peptide are administered together as a composition.  
     
     
         14 . The method of  claim 7 , wherein the adjuvant is administered before the Aβ peptide.  
     
     
         15 . The method of  claim 7 , wherein the adjuvant is administered after the Aβ peptide.  
     
     
         16 . The method of  claim 7 , wherein the adjuvant is alum.  
     
     
         17 . The method of  claim 7 , wherein the adjuvant is QS21.  
     
     
         18 . The method of  claim 7 , wherein the dose of the Aβ peptide is greater than 10 μg.  
     
     
         19 . The method of  claim 7 , wherein the Aβ peptide is administered with GM-CSF in the regime.  
     
     
         20 . A method of therapeutically treating a disease characterized by an amyloid deposit of Aβ in a patient having the disease, comprising: 
 administering an Aβ peptide selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6, in a regime effective to induce an immune response comprising antibodies to the Aβ peptide and thereby therapeutically treat the disease in the patient; and monitoring the patient for the immune response, wherein the monitoring comprises detecting antibodies having Aβ peptide binding specificity.    
     
     
         21 . The method of  claim 20 , wherein the adjuvant is M-CSF.  
     
     
         22 . The method of  claim 20 , wherein the dose of the Aβ peptide is greater than 20 μg.  
     
     
         23 . A method of prophylactically treating a disease characterized by an amyloid deposit of Aβ in a patient susceptible to the disease, comprising: 
 administering an Aβ peptide and an adjuvant in a regime effective to induce an immune response comprising antibodies to the Aβ peptide, the adjuvant enhancing the immune response to the Aβ peptide, and thereby prophylactically treat the disease in the patient; wherein the Aβ peptide is selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6.    
     
     
         24 . The method of  claim 23 , wherein the patient is a human.  
     
     
         25 . The method of  claim 23 , wherein the disease is Alzheimer's disease.  
     
     
         26 . The method of any one of claims  23 ,  24  or  25 , wherein the patient is asymptomatic.  
     
     
         27 . The method of any one of claims  23 ,  24  or  25 , wherein the patient is under 50.  
     
     
         28 . The method of any one of claims  23 ,  24  or  25 , wherein the patient has inherited risk factors indicating susceptibility to Alzheimer's disease.  
     
     
         29 . The method of any one of claims  23 ,  24  or  25 , wherein the patient has no known risk factors for Alzheimer's disease.  
     
     
         30 . The method of  claim 23 , wherein the dose of the Aβ peptide is greater than 20 μg.  
     
     
         31 . A method of prophylactically treating a disease characterized by an amyloid deposit of Aβ in a patient susceptible to the disease, comprising: 
 administering an Aβ peptide selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6, in a regime effective to induce an immune response comprising antibodies to the Aβ peptide and thereby prophylactically treat the disease in the patient, wherein the dose of the Aβ peptide administered to the patient is at least 50 μg.    
     
     
         32 . The method of  claim 31 , wherein the dose of the Aβ peptide administered to the patient is at least 100 μg.  
     
     
         33 . The method of  claim 31 , wherein the Aβ peptide is administered in aggregated form.  
     
     
         34 . The method of any one of claims  31 ,  32  or  33 , wherein the Aβ peptide is administered orally, subcutaneously, intramuscularly, topically or intravenously.  
     
     
         35 . The method of any one of claims  31 ,  32  or  33 , wherein the Aβ peptide is administered intramuscularly or subcutaneously.  
     
     
         36 . The method of any one of claims  31 ,  32  or  33 , further comprising monitoring the patient for the immune response, wherein the monitoring comprises detecting antibodies having Aβ peptide binding specificity.  
     
     
         37 . The method of  claim 31 , wherein the adjuvant and the Aβ peptide are administered together as a composition.  
     
     
         38 . The method of  claim 31 , wherein the adjuvant is administered before the Aβ peptide.  
     
     
         39 . The method of  claim 31 , wherein the adjuvant is administered after the Aβ peptide.  
     
     
         40 . The method of  claim 31 , wherein the adjuvant is alum.  
     
     
         41 . The method of  claim 31 , wherein the adjuvant is QS21.  
     
     
         43 . The method of  claim 31 , wherein the Aβ peptide is administered with GM-CSF in the regime.  
     
     
         44 . A method of prophylactically treating a disease characterized by an amyloid deposit of Aβ in a patient susceptible to the disease, comprising: 
 administering an Aβ peptide selected from the group consisting of the first 39 residues of SEQ ID NO:6, the first 40 residues of SEQ ID NO:6, the first 41 residues of SEQ ID NO:6, the first 42 residues of SEQ ID NO:6, and the amino acid sequence of SEQ ID NO:6, in a regime effective to induce an immune response comprising antibodies to the Aβ peptide and thereby prophylactically treat the disease in the patient; and monitoring the patient for the immune response, wherein the monitoring comprises detecting antibodies having Aβ peptide binding specificity.    
     
     
         45 . The method of  claim 44 , wherein the adjuvant is M-CSF.

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