Use and composition for treating dementia

Abstract

There is described a method for increasing the maximal tolerated dose and thus the efficacy of an acetyl choline esterase inhibitor (AChEI) in a patient suffering from an Alzheimer type dementia by decreasing concomitant adverse effects by administration of said AChEI in combination with a non-selective, peripheral anticholinergic agent, whereby an enhanced acetyl choline esterase inhibition in the CNS of said patient is achieved and alleviation of the symptoms of Alzheimer type dementia in said patient is thereby improved to a greater extent. The use of a non-selective, peripheral anticholinergic agent (nsPAChA) for the preparation of a pharmaceutical composition for increasing the maximal tolerated dose and thus the efficacy of an acetyl choline esterase inhibitor (AChEI) in a patient suffering from an Alzheimer type dementia and pharmaceutical compositions comprising a non-selective peripheral anticholinergic agent of formula II as illustrated in the description and an acetylcholine esterase inhibitor are also described.

1 - 6 . (canceled) 
     
     
         7 . A pharmaceutical unit form which comprises
 (a) a non-selective, peripheral muscarinic anticholinergic agent (nsPAChA); and   
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
         (b) an anticholinesterase inhibitor (AChEI) selected from the group consisting of tacrine, donepezil, rivastigmine, galantamine, and pharmaceutically acceptable salts thereof, in a daily dose from 1.5 to 4 times greater than a recommended maximal dose approved by the U.S. FDA; in admixture with at least a pharmaceutical carrier. 
       
     
     
         8 . The unit form of  claim 7 , wherein said nsPAChA is a selected from the group consisting of pharmaceutical acceptable salts of trospium, pharmaceutically acceptable salts of solifenacin, pharmaceutically acceptable salts of propiverine, pharmaceutically acceptable salts of oxyphencyclimine and pharmaceutically acceptable salts of tolterodine. 
     
     
         9 . The unit form of  claim 7 , wherein said nsPAChA is a pharmaceutical acceptable salt of trospium in an amount of from 4 mg to 120 mg. 
     
     
         10 . The unit form of  claim 7 , wherein said nsPAChA is a pharmaceutically acceptable salt of trospium and AChEI is selected from the group consisting of tacrine, in an amount of from 10 mg to 160 mg, donepezil and its pharmaceutically acceptable salts, in an amount of from 5 mg to 40 mg, rivastigmine and its pharmaceutically acceptable salts, in an amount of from 1.5 to 36 mg, galantamine, in an amount of from 4 to 48 mg and huperzine A, in an amount of from 100 μg to 1.2 mg. 
     
     
         11 - 12 . (canceled)