Composition for improving cognition and memory

Abstract

The invention relates to a pharmacologically active combination, having utility in treating insomnia patients, which comprises: (a) at least one first active ingredient selected from melatonin, other melatonergic agents, melatonin agonists and melatonin antagonists; and (b) at least one second active ingredient selected from nicotine and nicotine receptor agonists; to use of a medicament containing component (a) with or without component (b) for alleviation of at least one adverse effect which occurs in a patient in the course of nicotine replacement therapy, or otherwise, selected from impairment of the quality of sleep, impairment of cognition and impairment of memory, as well as to a kit having utility in treating insomnia patients, which comprises components (a) and (b) in unit dosage form.

1 . A pharmacologically active combination comprising:
 (a) a first active ingredient selected from melatonin or a melatonin agonist; and   (b) at least one second active ingredient selected from nicotine or a nicotine receptor agonist;   wherein said first active ingredient is provided in controlled, sustained or prolonged release form and said pharmacologically active combination contains said first and second active ingredients in an amount effective for treatment of cognitive dysfunction and sleep impairment.   
     
     
         2 . The pharmacologically active combination of  claim 1 , which is characterized by at least one of the following features:
 (i) each ingredient comprises also at least one diluent, carrier or adjuvant;   (ii) the pharmacologically active combination is in the form of at least one dosage unit, and said at least one dosage unit for at least said first active ingredient is adapted for oral, rectal, parenteral, transbuccal, intrapulmonary or transdermal administration;   (iii) the pharmacologically active combination is in a depot form which will release said at least one of said first and second active ingredients slowly in the body, over a preselected time period;   (iv) said ingredient (a) is melatonin;   (v) said ingredient (b) is a nicotine receptor agonist;   (vi) said first and second active ingredients (a) and (b) are formulated in a single formulation.   
     
     
         3 . The pharmacologically active combination of  claim 2 , which is in said form of dosage units, wherein each dosage unit contains at least one of said active ingredients in an amount which lies within the range of 0.025-100 mg. 
     
     
         4 . The pharmacologically active combination of  claim 3 , wherein said amount lies within the range of 0.25 to 50 mg. 
     
     
         5 . The pharmacologically active combination of  claim 4 , wherein said amount lies within the range of 0.5 to 40 mg. 
     
     
         6 . A method of treating a patient suffering from cognitive dysfunction and sleep impairment comprising administering to said patient a first medicament and a second medicament, said first medicament comprising at least one first active ingredient (a) selected from melatonin or a melatonin agonist, and said second medicament comprising at least one second active ingredient (b) selected from nicotine or a nicotine receptor agonist. 
     
     
         7 . The method of  claim 6 , wherein each of said medicaments is characterized respectively by at least one of the following features:
 (i) at least one of said medicaments further comprises at least one diluent, carrier or adjuvant;   (ii) at least one of said medicaments is in the form of dosage units, and said dosage units are adapted for oral, rectal, parenteral, transbuccal, intrapulmonary or transdermal administration;   (iii) at least one of said medicaments is a controlled sustained or prolonged release formulation;   (iv) at least one of said medicaments is in a depot form which will release at least one of said active ingredients slowly in the body, over a preselected time period;   (v) said ingredient (a) is melatonin;   (vi) said ingredient (b) is a nicotine receptor agonist;   (vii) said first and second active ingredients (a) and (b) are formulated in a single formulation.   
     
     
         8 . The method according to  claim 7 , wherein each of said first and second medicaments is in the form of dosage units, wherein each said dosage unit contains at least one of said active ingredients in an amount which lies within the range of 0.025-100 mg. 
     
     
         9 . The method of  claim 8 , wherein said amount lies within the range of 0.25-50 mg. 
     
     
         10 . The method of  claim 9 , wherein said amount lies within the range of 0.5-40 mg. 
     
     
         11 . The method of  claim 6 , wherein said patient suffers from sleep impairment and at least one of Alzheimer's disease, schizophrenia, and attention deficit hyperactivity disorder (ADHD). 
     
     
         12 . The method of  claim 6 , wherein said patient suffers from sleep impairment and Alzheimer's disease. 
     
     
         13 . The method of  claim 6 , wherein said nicotine receptor agonist is an acetylcholinesterase inhibitor. 
     
     
         14 . The method of  claim 6 , wherein said patient further suffers from insomnia. 
     
     
         15 . A kit having utility in treating a patient suffering from cognitive dysfunction and sleep impairment comprising:
 (a) a first pharmaceutical formulation in unit dosage form comprising, in addition to at least one diluent, carrier or adjuvant, at least one first active ingredient selected from melatonin or a melatonin agonist, which is in a form adapted for controlled, sustained or prolonged release; and   (b) a second pharmaceutical formulation in unit dosage form comprising, in addition to at least one diluent, carrier or adjuvant, at least one second active ingredient selected from nicotine or a nicotine receptor agonist;   wherein the dosage units in (a) and (b) are independently selected from those adapted for oral, rectal, parenteral, transbuccal, intrapulmonary or transdermal administration.   
     
     
         16 . The kit of  claim 15 , wherein said component (b) is not in a controlled, sustained or prolonged release form. 
     
     
         17 . The kit of  claim 15 , which is further characterized by at least one of the following features:
 (i) said at least one first active ingredient comprises melatonin;   (ii) said at least one second active ingredient comprises a nicotine receptor agonist;   (iii) said first and second active ingredients, and said further active ingredient if present, are present in said dosage units in an amount which lies within the range of 0.025-100 mg.   
     
     
         17 . The kit of  claim 16 , wherein said first and second active ingredients, and said further active ingredient if present, are present in said dosage units in an amount which lies within the range of 0.25 to 50 mg. 
     
     
         18 . The kit of  claim 17 , wherein said first and second active ingredients, and said further active ingredient if present, are present in said dosage units in an amount which lies within the range of 0.5 to 40 mg.