Methods of Maintaining, Treating or Improving Cognitive Function

Abstract

A method of administering an effective amount of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof, to a patient in need thereof.

1 - 36 . (canceled) 
     
     
         37 . A method of minimizing progression of a cognitive impairment in a patient in need thereof, comprising:
 administering to the patient, for an extended period of at least 12 weeks, a daily dose of a pharmaceutical composition comprising (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof;   
       wherein the cognitive impairment is limited cognitive impairment (LCI), mild cognitive impairment (MCI), Alzheimer's disease, or dementia of the Alzheimer's-type; 
       wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: MMSE, ADAS-Cog-13, ADAS-Cog-11, COWAT, CFT, or CDR-SB. 
     
     
         38 . The method of  claim 37 , wherein the patient has scored a sub-normal value on one or more cognitive assessment tests, comprising: ADAS-Cog-13, ADAS-Cog-11, COWAT, CFT, or CDR-SB. 
     
     
         39 . The method of  claim 37 , wherein the patient has scored a sub-normal value on an MMSE test. 
     
     
         40 . The method of  claim 37 , wherein the patient has scored >14 to <24 on a MMSE test or a score of >2 on a CDR-SB test. 
     
     
         41 . The method of  claim 37 , wherein the daily dose is between 1.0 mg and 4.5 mg of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof. 
     
     
         42 . The method of  claim 37 , wherein the daily dose is 0.3 mg, 1.0 mg, 2.0 mg, or 3.0 mg, of (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof. 
     
     
         43 . The method of  claim 37 , wherein the extended period is at least 23 weeks. 
     
     
         44 . The method of  claim 37 , wherein the extended period is at least 24 weeks. 
     
     
         45 . The method of  claim 37 , wherein said patient has been previously treated or is currently being treated with an AChEI. 
     
     
         46 . The method of  claim 37 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate. 
     
     
         47 . The method of  claim 37 , wherein the pharmaceutically acceptable salt of the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, is (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, hydrochloride, monohydrate, polymorph form I. 
     
     
         48 . The method of  claim 37 , wherein the (R)-7-chloro-N-(quinuclidin-3-yl)benzo[b]thiophene-2-carboxamide, or a pharmaceutically acceptable salt thereof, is administered in the form of a pharmaceutical composition comprising at least one pharmaceutically acceptable carrier, excipient or diluent. 
     
     
         49 . The method of  claim 37 , wherein the pharmaceutical composition is in the form of a tablet. 
     
     
         50 . The method of  claim 37 , wherein the cognitive impairment is limited cognitive impairment (LCI). 
     
     
         51 . The method of  claim 37 , wherein the cognitive impairment is mild cognitive impairment (MCI). 
     
     
         52 . The method of  claim 37 , wherein the cognitive impairment is Alzheimer's disease. 
     
     
         53 . The method of  claim 52 , wherein the Alzheimer's disease is mild-to-moderate Alzheimer's disease. 
     
     
         54 . The method of  claim 37 , wherein the cognitive impairment is dementia of the Alzheimer's-type. 
     
     
         55 . The method of  claim 37 , wherein the method minimizes progression of one or more symptoms associated with the cognitive impairment in the patient. 
     
     
         56 . The method of  claim 37 , wherein the method improves one or more cognitive or behavioral symptoms associated with the cognitive impairment. 
     
     
         57 . The method of  claim 37 , wherein the method provides a pro-cognitive effect in at least one of the following: visual motor, learning, delayed memory, or executive function, in said patient.