Compositions and methods for treating alzheimer's disease

Abstract

The present disclosure provides for a hyperimmune preparation comprising human polyclonal antibodies or fragments thereof specific to a cyclic peptide having an amino acid sequence comprising SNK. The cyclic peptide may comprise an amino acid sequence GSNK (SEQ ID NO: 1), SNKG(SEQ ID NO: 2), GSNKG (SEQ ID N0:3), CSNKG (SEQ ID NO: 4), CGSNKGC (SEQ ID NO: 5), CGSNKGG (SEQ ID NO: 6), or CCGSNKGC (SEQ ID NO: 7). The antibodies in the hyperimmune preparation may have a titer ranging from about 200 to about 400 mean fluorescence intensity (MFI). In one embodiment, greater than about 80% of the antibodies in the hyperimmune preparation are IgG. The fragments of the antibodies are Fab, F(ab′)2, scFv, disulfide linked Fv, or mixtures thereof.

What is claimed is: 
     
         1 . A hyperimmune preparation comprising human polyclonal antibodies or fragments thereof specific to a cyclic peptide having an amino acid sequence comprising SNK. 
     
     
         2 . The hyperimmune preparation of  claim 1 , wherein the antibodies have a titer ranging from about 200 to about 400 mean fluorescence intensity (MFI). 
     
     
         3 . The hyperimmune preparation of  claim 1 , wherein greater than about 80% of the antibodies are IgG. 
     
     
         4 . The hyperimmune preparation of  claim 1 , wherein the hyperimmune preparation is prepared from human plasma or serum. 
     
     
         5 . The hyperimmune preparation of  claim 4 , wherein the hyperimmune preparation is intravenous immunoglobulin (IVIG). 
     
     
         6 . The hyperimmune preparation of  claim 1 , wherein the fragments of the antibodies are Fab, F(ab′) 2 , scFv, disulfide linked Fv, or mixtures thereof. 
     
     
         7 . The hyperimmune preparation of  claim 1 , in a form suitable for parenteral injection or infusion. 
     
     
         8 . The hyperimmune preparation of  claim 1 , wherein the cyclic peptide comprises an amino acid sequence GSNK (SEQ ID NO: 1), SNKG (SEQ ID NO: 2), GSNKG (SEQ ID NO: 3), CSNKG (SEQ ID NO: 4), CGSNKGC (SEQ ID NO: 5), CGSNKGG (SEQ ID NO: 6), or CCGSNKGC (SEQ ID NO: 7). 
     
     
         9 . A method for treatment or prophylaxis of Alzheimer's Disease in a subject comprising the step of administering to the subject a pharmaceutically effective amount of a hyperimmune preparation comprising human polyclonal antibodies or fragments thereof specific to a cyclic peptide having an amino acid sequence comprising SNK. 
     
     
         10 . The method of  claim 9 , wherein the hyperimmune preparation is administered by parenteral injection or infusion. 
     
     
         11 . The method of  claim 10 , wherein the hyperimmune preparation is administered by intravenous injection or infusion. 
     
     
         12 . The method of  claim 10 , wherein the hyperimmune preparation is administered at a dose ranging from about 10 μg to about 200 mg antibodies per kg body weight. 
     
     
         13 . The method of  claim 12 , wherein the hyperimmune preparation is administered at a dose ranging from about 10 μg to about 400 μg antibodies per kg body weight. 
     
     
         14 . The method of  claim 9 , wherein the hyperimmune preparation is administered subcutaneously, intramuscularly, transdermally or orally. 
     
     
         15 . The method of  claim 9 , wherein the hyperimmune preparation is administered consecutively, simultaneously or in combination with an acetylcholinesterase inhibitor or an NMDA receptor antagonist. 
     
     
         16 . The method of  claim 15 , wherein the acetylcholinesterase inhibitor is tacrine, rivastigmine, galantamine or donepezil. 
     
     
         17 . The method of  claim 15 , wherein the NMDA receptor antagonist is memantine. 
     
     
         18 . A method of diagnosing Alzheimer's Disease in a subject comprising the steps of:
 (a) obtaining a biological sample from the subject;   (b) quantifying in the sample the level of antibodies specific to a cyclic peptide having an amino acid sequence comprising SNK; and   (c) comparing the level of the antibodies in step (b) with a control sample.   
     
     
         19 . A method of predicting a subject's risk of developing Alzheimer's Disease comprising the steps of:
 (a) obtaining a biological sample from the subject;   (b) quantifying in the sample the level of antibodies specific to a cyclic peptide having an amino acid sequence comprising SNK; and   (c) comparing the level of the antibodies in step (b) with a control sample.   
     
     
         20 . The method of  claim 18  or  19 , wherein the biological sample is plasma, tissues, cells, biofluids, or combinations thereof. 
     
     
         21 . The method of  claim 20 , wherein the biofluid is cerebrospinal fluid (CSF) or blood. 
     
     
         22 . The method of  claim 18  or  19 , wherein the control sample is a sample from one or more Alzheimer's Disease-free subjects, or a sample from the subject obtained a time period ago wherein the time period ranges from about 6 months to about 5 years.