Chlorite in the Treatment of Neurodegenerative Disease

Abstract

The invention features methods of treating a macrophage-associated neurodegenerative disease such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease (AD), or multiple sclerosis (MS) in a subject by administering chlorite in an amount effective to decrease blood immune cell activation. The invention also features methods of monitoring therapy by assessing blood immune cell activation before and after therapy.

1 .- 20 . (canceled) 
     
     
         21 . A method comprising:
 assessing a level of activated monocytes and/or proliferating macrophages in a biological sample obtained from an individual, wherein said individual has or is suspected of having a macrophage-associated neurological disorder, wherein said individual is receiving a treatment, and wherein said treatment comprises administration of chlorite;   wherein said assessing provides guidance for providing or altering a level of said treatment.   
     
     
         22 . The method of  claim 21 , wherein said macrophage-associated neurological disorder is amyotrophic lateral sclerosis (ALS). 
     
     
         23 . The method of  claim 21 , wherein said assessing comprises assessing a level of activated monocytes by measuring one or more markers that indicate monocyte activation, differentiation and/or proliferation. 
     
     
         24 . The method of  claim 21 , wherein said assessing comprises assessing a level of activated monocytes by measuring a level of HLA-DR in a population of CD14+ cells and/or the presence of CD16+ cells in a population of CD14+ cells and/or the presence of CD14+/CD16+ cells in said sample. 
     
     
         25 . The method of  claim 21 , wherein said assessing comprises assessing a level of proliferating macrophages by measuring an elevation in proliferation and/or activation markers relative to non-disease blood macrophages. 
     
     
         26 . The method of  claim 21 , further comprising comparing said level of proliferating macrophages to a normal level of proliferating macrophages. 
     
     
         27 . The method of  claim 21 , wherein said chlorite is administered in a form of a matrix of chlorite ions. 
     
     
         28 . The method of  claim 21 , wherein said chlorite is administered in an aqueous formulation. 
     
     
         29 . The method of  claim 21 , wherein said chlorite is administered in a form of a pharmaceutically acceptable chlorite salt. 
     
     
         30 . The method of  claim 29 , wherein said chlorite salt is sodium chlorite. 
     
     
         31 . A method of monitoring therapy in a subject receiving treatment for ALS, the method comprising:
 assessing a level of pathologic macrophages in a sample obtained from a patient receiving treatment for amyotrophic lateral sclerosis (ALS), wherein the treatment comprises administration of chlorite, and   comparing the level of pathologic macrophages to a normal level of pathologic macrophages.   
     
     
         32 . The method of  claim 31 , wherein said assessing said level of pathologic macrophages comprises measuring one or more markers that indicate monocyte activation, differentiation and/or proliferation. 
     
     
         33 . The method of  claim 31 , wherein said assessing said level of pathologic macrophages comprises measuring a level of HLA-DR in a population of CD14+ cells and/or the presence of CD16+ cells in a population of CD14+ cells and/or the presence of CD14+/CD16+ cells in said sample. 
     
     
         34 . The method of  claim 31 , wherein said proliferating macrophages exhibit an elevation in proliferation and/or activation markers relative to non-disease blood macrophages. 
     
     
         35 . The method of  claim 31 , wherein said chlorite is administered in a form of a matrix of chlorite ions. 
     
     
         36 . The method of  claim 31 , wherein said chlorite is administered in an aqueous formulation. 
     
     
         37 . The method of  claim 31 , wherein said chlorite is administered in a form of a pharmaceutically acceptable chlorite salt. 
     
     
         38 . The method of  claim 37 , wherein said chlorite salt is sodium chlorite.