Therapeutic agent composition and method of use, for treatment of mild congnitive impairment, depression, and psychological disorders

Abstract

The present invention generally relates to the use of cyclic Prolyl Glycine (“cyclic PG” or “cPG”) and analogues and mimetics thereof, as neuroprotective agents for the treatment and or prevention of cognitive impairment and neurological disorders including but not limited to cerebral ischemia or cerebral infarction, status epilepticus, perinatal asphyxia, anoxia, and cerebral trauma, as well as to the treatment and prevention of chronic neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, and Dementia with Lewy Bodies. The present invention also generally provides manufacturing methods to prepare of dosage forms. The present invention further generally relates to the use of cyclic Prolyl Glycine and analogues and mimetics thereof, as neuroprotective and neuro-regenerating agents for the treatment and or prevention of depression and other psychological disorders.

What is claimed is: 
     
         1 . A method of preventing the symptoms of Parkinson's disease in a mammal, comprising:
 a. providing a mammal in need of preventing the symptoms of Parkinson's disease;   b. administering a pharmaceutically effective amount of cyclic Prolyl Glycine (cPG) or its analogues (cyclic(tri(Prolyl Glycine) or cyclic Glycyl 2-Allyl Proline, or cyclic Glycyl-Alkyl Proline or cyclic Glycyl-2-Methyl-Proline (cPMeG), or a combination thereof, collectively called a cPG compound, to said mammal;   wherein said mammal is prevented from having the symptoms of Parkinson's disease.   
     
     
         2 . The method according to  claim 1 ,
 wherein said pharmaceutically effective amount of said cPG compound is from about 1 μg to about 100 mg per kg of body weight.   
     
     
         3 . The method of  claim 1 ,
 wherein said pharmaceutically effective amount of said cPG compound is administered at an amount from about 0.1 mg to about 10 mg/kg per day, from about 0.5 mg to about 20 mg/kg per day, from about 0.2 mg to about 40 mg/kg per day, from about 5 mg to about 50 mg/kg per day, or from about 10 micrograms to about 100 mg/kg per day.   
     
     
         4 . The method of  claim 1 ,
 wherein said pharmaceutically effective amount or said cPG compound has a lower limit of about 0.1 milligrams per kilogram mass (mg/kg) of said mammal and an upper limit of about 10 mg/kg of said mammal.   
     
     
         5 . The method of  claim 1   wherein said pharmaceutically effective amount of said cPG compound is between about 20 mg and about 80 mg per day, or between about 20 mg and about 100 per day.   
     
     
         6 . The method according to  claim 1 ,
 wherein said administering is in the form of a pharmaceutical composition including a pharmaceutically acceptable carrier.   
     
     
         7 . The method according to  claim 1 ,
 wherein said administering is in combination with artificial cerebrospinal fluid.   
     
     
         8 . The method according to  claim 1 ,
 wherein said administering is intravenous.   
     
     
         9 . The method according to  claim 1 ,
 wherein said administering is combined with the administration of a neuroprotective agent, insulin-like growth factor-I (IGF-I) insulin growth-dike factor-II (IGF-II), or a combination thereof.   
     
     
         10 . The method according to  claim 1 ,
 wherein said administering is combined with the administration of an anti-inflammatory agent, an anti-integrin alpha 4 subunit rea gent, or a combination thereof.   
     
     
         11 . The method of  claim 1 ,
 wherein said administering is combined with administration of an anti-inflammatory agent.   
     
     
         12 . The method of  claim 1 ,
 wherein said cPG compound comprises an aqueous solution and one or more pharmaceutically acceptable excipients, additives, carriers or adjuvants.   
     
     
         13 . The method of  claim 1 ,
 wherein said ePG compound comprises one or more pharmaceutically acceptable excipients, carriers, additives, adjuvants or binders in a tablet or capsule.   
     
     
         14 . The method of  claim 1 ,
 wherein said pharmaceutically effective amount of said cPG compound is administered via an oral, intraperitoneal, intravascular, peripheral circulation, subcutaneous, intraorbital, ophthalmic, intraspinal, intracisternal, topical, infusion, implant, aerosol, inhalation, scarification, intracapsular, intramuscular, intranasal, buccal, transdermal, pulmonary, rectal, vaginal, or a combination thereof.   
     
     
         15 . The method of  claim 1 ,
 wherein said mammal is a human.   
     
     
         16 . A method of treating the symptoms of Parkinson's disease in a mammal, comprising:
 a. providing a mammal in need of treating of the symptoms of Parkinson's disease;   b. administering a pharmaceutically effective amount of cyclic Prolyl Glycine (cPG) or its analogues (cyclic(tri(Prolyl Glycine) or cyclic Glycyl-2-Allyl Proline, or cyclic Glycyl-Alkyl Proline or cyclic Glycyl-2-Methyl-Proline (cPMeG), or a combination thereof, collectively called a cPG compound, to said mammal;   wherein said mammal is treated for symptoms of Parkinson's disease.   
     
     
         17 . A method of preventing the symptoms of Dementia with Lewy Bodies in a mammal, comprising:
 a. providing a mammal in need of preventing the symptoms of Dementia with Lewy Bodies;   b. administering a pharmaceutically effective amount of cyclic Prolyl Glycine (cPG) or its analogues (cyclic(tri(Prolyl Glycine) or cyclic Glycyl-2-Allyl Proline, or cyclic Glycyl-Alkyl Proline or cyclic Glycyl-2-Methyl-Proline (cPMeG), or a combination thereof, collectively called a cPG compound, to said mammal;   wherein said mammal is prevented from having the symptoms of Dementia with Lewy bodies.   
     
     
         18 . A method of treating the symptoms of Dementia with Lewy Bodies in a mammal, comprising:
 a. providing a mammal in need of treating the symptoms of Dementia with Lewy Bodies;   b. administering a pharmaceutically effective amount of cyclic Prolyl Glycine (cPG) or its analogues (cyclic(tri(Prolyl Glycine) or cyclic Glycyl-2-Allyl Proline, or cyclic Glycyl-Alkyl Proline or cyclic Glycyl-2-Methyl-Proline (cPMeG), or a combination thereof, collectively called a cPG compound, to said mammal;   wherein said mammal is treated for symptoms of Dementia with Lewy bodies.