Method for the treatment, alleviation of symptoms of, relieving, improving and preventing a cognitive disease, disorder or condition

Abstract

The present invention provides uses of a salt adduct comprising at least one positively charged moiety being a pyridoxine or a derivative thereof and at least one carboxylated 5- to 7-membered lactam ring, optionally additionally substituted, for the preparation of a medicament for the treatment, alleviation of symptoms of, relieving, improving and preventing a cognitive disease, disorder or condition in a subject. Additionally, the invention provides use of said salt adducts for the preparation of medicaments for the improvement of cognitive functions in a healthy subject.

1 . Use of a salt adduct comprising at least one positively charged moiety being a pyridoxine or a derivative thereof and at least one carboxylated 5- to 7-membered lactam ring, optionally additionally substituted, for the preparation of a medicament for the treatment, alleviation of symptoms of, relieving, improving and preventing a cognitive disease, disorder or condition in a subject. 
     
     
         2 . Use of a salt adduct comprising at least one positively charged moiety being a pyridoxine or a derivative thereof and at least one carboxylated 5- to 7-membered lactam ring, optionally additionally substituted, for the preparation of a medicament for the improvement of cognitive functions in a healthy subject. 
     
     
         3 . Use according to  claim 1  or  2 , wherein said positively charged moiety is a compound of formula (I): 
       
         
           
           
               
               
           
         
         wherein 
         R 1  is straight or branched C 1 -C 6  alkyl; 
         R 2  is selected from —OH, straight or branched C 1 -C 6  alkoxy, and straight or branched C 1 -C 6  alkoxycarbonyl; 
         R 3  and R 4  are each independently selected from formyl, straight or branched C 1 -C 6  alkyl optionally substituted by at least one halogen, amine, hydroxy, C 1 -C 6  alkoxy, thiol and C 1 -C 6  alkoxycarbonyl. 
       
     
     
         4 . Use according to any one of the preceding claims, wherein said carboxylated lactam ring is selected from the group consisting of: 
       
         
           
           
               
               
           
         
         wherein 
         R 6  is selected from H, straight or branched C 1 -C 6  alkyl optionally substituted by at least one halogen, straight or branched C 2 -C 6  alkenyl, straight or branched C 2 -C 6  alkynyl, cycloalkyl, aryl and heteroaryl optionally substituted by a C 1 -C 6  alkyl; 
         R 7 , R 8 , R 9 , R 10  R 11 , R 12 , R 13  and R 14  are each independently selected from H, straight or branched C 1 -C 6  alkyl, C 2 -C 6  alkenyl, C 2 -C 6  alkynyl, cycloalkyl, aryl and heteroaryl optionally substituted by at least one group selected from C 1 -C 6  alkyl, halogen, amino, cyano, nitro, thiol, C 1 -C 6  alkoxy, aminocarbonyl, C 1 -C 6  alkoxycarbonyl, C 1 -C 6  carboxyalkyl, C 1 -C 6  alkoxycarbonylalkyl and amidino. 
       
     
     
         5 . Use according to any one of the preceding claims, wherein said salt adduct is selected from the following: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
     
     
         6 . Use according to  claim 1 , wherein said cognitive disease, disorder or condition is selected from Attention Deficit/Hyperactivity Disorder (ADHD/ADD), impaired memory (Amnesia), impaired wakefulness, mental fatigue conditions, Shift Work Sleep Disorder, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, poor concentration, and poor focus or any combination thereof. 
     
     
         7 . Use according to  claim 1 , wherein said cognitive disease, disorder or condition is selected from learning disabilities, impairment of memory, cognitive dysfunction, alteration of cognitive function, including Alzheimer's disease, or any type of encephalopathy, including uremic and hepatic encephalopathy. 
     
     
         8 . Use according to  claim 1 , wherein said cognitive disease, disorder or condition is a neurobehavioral disease, disorder or condition. 
     
     
         9 . Use according to  claim 8 , wherein said neurobehavioral disease, disorder or condition is selected from Attention Deficit Hyperactivity Disorder (ADHD), Attention Deficit Disorder (ADD), impaired memory, poor concentration, and poor focus. 
     
     
         10 . Use according to  claim 1 , wherein said cognitive disease, disorder or condition is selected from Attention Deficit Disorder (ADD) or Hyperactivity Disorder (ADHD/ADD), impaired memory (Amnesia), impaired wakefulness, mental fatigue conditions, Shift Work Sleep Disorder, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, poor concentration, and poor focus or any combination thereof. 
     
     
         11 . Use according to  claim 2 , wherein said cognitive function selected from temporary or long term learning disabilities, temporary or long term impairment of memory, temporary or long term cognitive dysfunction, temporary or long term alteration of cognitive function, temporary or long term concentration impairment, temporary or long term focus impairment, temporary or long term impaired wakefulness, temporary or long term mental fatigue conditions, temporary or long term Shift Work Sleep Disorder, or any combination thereof. 
     
     
         12 . Use according to any one of the preceding claims, wherein said subject is a child, an adolescent, an adult, or an elderly person. 
     
     
         13 . Use according to any one of the preceding claims, wherein said salt adduct is formulated in a sustained-, delayed or controlled-release dosage form. 
     
     
         14 . Use according to any one of the preceding claims, wherein said salt adduct is formulated in a sustained-, delayed or controlled-release dosage form combined with a salt adduct formulated in an immediate or burst effect dosage form. 
     
     
         15 . Use according to any one of the preceding claims, wherein said salt adduct is formulated to deliver up to 0.1-1000 mg/kg body weight/day of said salt adduct, preferably 1-400 mg/kg body weight of said salt adduct, in a single dose administration or portion thereof. 
     
     
         16 . Use according to any one of the preceding claims, wherein said salt adduct is formulated together with at least one additional pharmaceutically active agent.